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VIDEO: Hidradenitis suppurativa in pediatrics similar to that in adults
WASHINGTON– Hidradenitis suppurativa (HS) can present early in adolescence, and the approach to treatment in pediatric patients is similar to treatment in adults, “with a few caveats,” A. Yasmine Kirkorian, MD, said in a video interview at an educational session held by George Washington University.
While the literature often states that HS starts in a person’s 20s, it primarily starts in adolescence, sometimes earlier, with a presentation that is similar to that seen in adults and appearing at the same sites, such as the armpits and groin, said Dr. Kirkorian a pediatric dermatologist at Children’s National Health System and George Washington University, Washington.
“As dermatologists, we know this. Kids are getting this disease, but we need to characterize that better in the literature so that we can start to apply the adult style therapeutics in clinical trials ... to children,” she added.
In the interview, Dr. Kirkorian discussed treatment strategies, as well as familial cases of HS and the links between HS and Down syndrome and inflammatory bowel disease in children.
The meeting was sponsored by AbbVie. Dr. Kirkorian had no financial conflicts to disclose.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WASHINGTON– Hidradenitis suppurativa (HS) can present early in adolescence, and the approach to treatment in pediatric patients is similar to treatment in adults, “with a few caveats,” A. Yasmine Kirkorian, MD, said in a video interview at an educational session held by George Washington University.
While the literature often states that HS starts in a person’s 20s, it primarily starts in adolescence, sometimes earlier, with a presentation that is similar to that seen in adults and appearing at the same sites, such as the armpits and groin, said Dr. Kirkorian a pediatric dermatologist at Children’s National Health System and George Washington University, Washington.
“As dermatologists, we know this. Kids are getting this disease, but we need to characterize that better in the literature so that we can start to apply the adult style therapeutics in clinical trials ... to children,” she added.
In the interview, Dr. Kirkorian discussed treatment strategies, as well as familial cases of HS and the links between HS and Down syndrome and inflammatory bowel disease in children.
The meeting was sponsored by AbbVie. Dr. Kirkorian had no financial conflicts to disclose.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WASHINGTON– Hidradenitis suppurativa (HS) can present early in adolescence, and the approach to treatment in pediatric patients is similar to treatment in adults, “with a few caveats,” A. Yasmine Kirkorian, MD, said in a video interview at an educational session held by George Washington University.
While the literature often states that HS starts in a person’s 20s, it primarily starts in adolescence, sometimes earlier, with a presentation that is similar to that seen in adults and appearing at the same sites, such as the armpits and groin, said Dr. Kirkorian a pediatric dermatologist at Children’s National Health System and George Washington University, Washington.
“As dermatologists, we know this. Kids are getting this disease, but we need to characterize that better in the literature so that we can start to apply the adult style therapeutics in clinical trials ... to children,” she added.
In the interview, Dr. Kirkorian discussed treatment strategies, as well as familial cases of HS and the links between HS and Down syndrome and inflammatory bowel disease in children.
The meeting was sponsored by AbbVie. Dr. Kirkorian had no financial conflicts to disclose.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
New guideline: Address GTCS frequency to reduce SUDEP risk
BOSTON – Generalized tonic-clonic seizures (GTCS) are a major risk factor for sudden unexpected death in epilepsy (SUDEP), which underscores the importance of advising people with epilepsy about controlling such seizures, according to a new practice guideline from the American Academy of Neurology and the American Epilepsy Society.
Though SUDEP is rare, with an incidence rate of 0.22/1,000 patient-years in children with epilepsy and 1.2/1,000 patient-years in adults with epilepsy, the guideline committee found that people with three or more GTCS per year are 15 times more likely to die suddenly than are those without this seizure type. The risk increases with increasing GTCS frequency. This translates to an absolute risk of up to 18 deaths per 1,000 patient-years for people with epilepsy who have frequent GTCS.
Specifically, the guideline recommends that , she said, adding that the guideline shows that “being free of seizures, particularly tonic-clonic seizures, is strongly associated with a decreased risk.”
Guideline coauthor, Elizabeth Donner, MD, added that, for this reason, the guideline recommends “that health professionals work with people who continue to have, specifically, these kind of seizures to try and reduce them with medications or with epilepsy surgery, actively weighing the risks and benefits of any new approach to seizure management.”
The recommendations are based on moderate (Level B) evidence.
The team also looked at numerous other risk factors for SUDEP and found that the strength of the evidence was too weak to support additional recommendations, said Dr. Donner, director of the comprehensive epilepsy program at The Hospital for Sick Children in Toronto and chair of the American Epilepsy Society SUDEP Task Force.
“More research is now needed to identify other preventable risk factors for SUDEP so that we can focus future studies on finding ways to reduce how often SUDEP occurs,” she added.
While the message regarding the importance of reducing seizure frequency is not new, it is important that this message be reiterated in the context of SUDEP, Dr. Donner said.
“It’s very important for it to be clear that the risk of frequent generalized tonic-clonic seizures – and we’re not talking about really frequent here; we’re talking about significant increased risk of death with only three per year – is not related only to maintaining a driver’s license, maintaining work, or other outcomes like that. It’s actually related to risk of death,” she said, noting that she hopes this is a motivator for pursuing treatments beyond medication when medication isn’t successful for treating seizures.
The guideline, which is endorsed by the International Child Neurology Association, is available online and in print (Neurology. 2017;88:1674–80).
Dr. Harden receives royalties from Wiley and Up-to-Date. Dr. Donner has received research support from the Canadian Institutes of Health Research, Dravet Canada, and SUDEP Aware. Other guideline authors reported numerous disclosures, including many industry sources.
BOSTON – Generalized tonic-clonic seizures (GTCS) are a major risk factor for sudden unexpected death in epilepsy (SUDEP), which underscores the importance of advising people with epilepsy about controlling such seizures, according to a new practice guideline from the American Academy of Neurology and the American Epilepsy Society.
Though SUDEP is rare, with an incidence rate of 0.22/1,000 patient-years in children with epilepsy and 1.2/1,000 patient-years in adults with epilepsy, the guideline committee found that people with three or more GTCS per year are 15 times more likely to die suddenly than are those without this seizure type. The risk increases with increasing GTCS frequency. This translates to an absolute risk of up to 18 deaths per 1,000 patient-years for people with epilepsy who have frequent GTCS.
Specifically, the guideline recommends that , she said, adding that the guideline shows that “being free of seizures, particularly tonic-clonic seizures, is strongly associated with a decreased risk.”
Guideline coauthor, Elizabeth Donner, MD, added that, for this reason, the guideline recommends “that health professionals work with people who continue to have, specifically, these kind of seizures to try and reduce them with medications or with epilepsy surgery, actively weighing the risks and benefits of any new approach to seizure management.”
The recommendations are based on moderate (Level B) evidence.
The team also looked at numerous other risk factors for SUDEP and found that the strength of the evidence was too weak to support additional recommendations, said Dr. Donner, director of the comprehensive epilepsy program at The Hospital for Sick Children in Toronto and chair of the American Epilepsy Society SUDEP Task Force.
“More research is now needed to identify other preventable risk factors for SUDEP so that we can focus future studies on finding ways to reduce how often SUDEP occurs,” she added.
While the message regarding the importance of reducing seizure frequency is not new, it is important that this message be reiterated in the context of SUDEP, Dr. Donner said.
“It’s very important for it to be clear that the risk of frequent generalized tonic-clonic seizures – and we’re not talking about really frequent here; we’re talking about significant increased risk of death with only three per year – is not related only to maintaining a driver’s license, maintaining work, or other outcomes like that. It’s actually related to risk of death,” she said, noting that she hopes this is a motivator for pursuing treatments beyond medication when medication isn’t successful for treating seizures.
The guideline, which is endorsed by the International Child Neurology Association, is available online and in print (Neurology. 2017;88:1674–80).
Dr. Harden receives royalties from Wiley and Up-to-Date. Dr. Donner has received research support from the Canadian Institutes of Health Research, Dravet Canada, and SUDEP Aware. Other guideline authors reported numerous disclosures, including many industry sources.
BOSTON – Generalized tonic-clonic seizures (GTCS) are a major risk factor for sudden unexpected death in epilepsy (SUDEP), which underscores the importance of advising people with epilepsy about controlling such seizures, according to a new practice guideline from the American Academy of Neurology and the American Epilepsy Society.
Though SUDEP is rare, with an incidence rate of 0.22/1,000 patient-years in children with epilepsy and 1.2/1,000 patient-years in adults with epilepsy, the guideline committee found that people with three or more GTCS per year are 15 times more likely to die suddenly than are those without this seizure type. The risk increases with increasing GTCS frequency. This translates to an absolute risk of up to 18 deaths per 1,000 patient-years for people with epilepsy who have frequent GTCS.
Specifically, the guideline recommends that , she said, adding that the guideline shows that “being free of seizures, particularly tonic-clonic seizures, is strongly associated with a decreased risk.”
Guideline coauthor, Elizabeth Donner, MD, added that, for this reason, the guideline recommends “that health professionals work with people who continue to have, specifically, these kind of seizures to try and reduce them with medications or with epilepsy surgery, actively weighing the risks and benefits of any new approach to seizure management.”
The recommendations are based on moderate (Level B) evidence.
The team also looked at numerous other risk factors for SUDEP and found that the strength of the evidence was too weak to support additional recommendations, said Dr. Donner, director of the comprehensive epilepsy program at The Hospital for Sick Children in Toronto and chair of the American Epilepsy Society SUDEP Task Force.
“More research is now needed to identify other preventable risk factors for SUDEP so that we can focus future studies on finding ways to reduce how often SUDEP occurs,” she added.
While the message regarding the importance of reducing seizure frequency is not new, it is important that this message be reiterated in the context of SUDEP, Dr. Donner said.
“It’s very important for it to be clear that the risk of frequent generalized tonic-clonic seizures – and we’re not talking about really frequent here; we’re talking about significant increased risk of death with only three per year – is not related only to maintaining a driver’s license, maintaining work, or other outcomes like that. It’s actually related to risk of death,” she said, noting that she hopes this is a motivator for pursuing treatments beyond medication when medication isn’t successful for treating seizures.
The guideline, which is endorsed by the International Child Neurology Association, is available online and in print (Neurology. 2017;88:1674–80).
Dr. Harden receives royalties from Wiley and Up-to-Date. Dr. Donner has received research support from the Canadian Institutes of Health Research, Dravet Canada, and SUDEP Aware. Other guideline authors reported numerous disclosures, including many industry sources.
AT AAN 2017
Parents rate telepediatric experience as better than office visits
Three-quarters of parents who have used telemedicine services for their children say the experience was better than an in-person office visit, according to a new study.
The analysis, released April 23, 2017, by Nemours Children’s Health System operating in five states, surveyed 500 child caregivers between February 15 and 20 about their awareness and usage of telemedicine services for their children aged 17 years and younger (mean age 10 years). Of caregivers surveyed, 15% had tried telemedicine services for their children, while another 61% reported they plan to use telemedicine in the next year for their children’s medical care, according to the study. Eight percent of caregivers did not plan to use telemedicine, and 31% of those surveyed were unsure.
Of child caregivers who have used telemedicine, 75% of reported their telemedicine experience was better than an in-person visit, according to the survey. Convenience, after-hours accessibility, and immediacy were the top three reasons caregivers sought an online visit for their child. Compared with a similar survey conducted by Nemours in 2014, parents’ use of telemedicine for their children has grown by 125% and awareness of the practice has increased by 88%, the study found.
The overall takeaway is that parents are using telemedicine because of its ease and accessibility and they’re having satisfactory experiences with the technology, said Shayan Vyas, MD, a pediatrician based in Nemours’ Orlando location and director of telemedicine for Nemours Children’s Hospital.
“Parents are citing telemedicine because of convenience and that’s true for other industries that have gone mobile,” Dr. Vyas said in an interview. “We no longer hail a cab at the intersection, we use our smartphones. We now use Amazon and other companies to order diapers and other everyday items. ... More and more, patients are driving telemedicine more than the systems or the providers.”
Caregivers surveyed said they are most willing to use telehealth services for cold and flu (58%), pink eye (51%), and rashes (48%) as well as well-child visits (41%). However, parents and caregivers were hesitant to use telemedicine for chronic conditions and reported they would likely never consider telehealth services for diabetes (53%), asthma (43%), ear pain (37%), and ADHD (36%).
The findings are expected because there are limitations for providers when it comes to treating some conditions and chronic diseases with telemedicine, Dr. Vyas said. He also stressed that telemedicine should not be used to replace the medical home for children.
“We’re working really hard to ensure there’s great pediatric care online and that the medical home stays intact,” he said. “We don’t want telemedicine to become the wild wild west of retail clinics where children are getting care from providers they don’t know or who are not in touch with their primary care world.”
Nemours has incorporated telemedicine throughout its health system with direct-to-consumer care for acute, chronic, and postsurgical appointments. The telehealth program, called Nemours CareConnect, is a 24/7, on-demand pediatric service that provides access to Nemours pediatricians through smartphones, tablets, or computers. In addition, Nemours CareConnect is used to bring pediatric specialists into affiliated community hospitals.
“At Nemours, we’ve seen how telemedicine can positively impact patients’ lives,” Dr. Vyas said. “The overwhelmingly positive response we’ve seen from parents who are early adopters of telemedicine really reinforces the feasibility of online doctor visits and sets the stage for real change in the way health care is delivered.”
agallegos@frontlinemedcom.com
On Twitter @legal_med
Three-quarters of parents who have used telemedicine services for their children say the experience was better than an in-person office visit, according to a new study.
The analysis, released April 23, 2017, by Nemours Children’s Health System operating in five states, surveyed 500 child caregivers between February 15 and 20 about their awareness and usage of telemedicine services for their children aged 17 years and younger (mean age 10 years). Of caregivers surveyed, 15% had tried telemedicine services for their children, while another 61% reported they plan to use telemedicine in the next year for their children’s medical care, according to the study. Eight percent of caregivers did not plan to use telemedicine, and 31% of those surveyed were unsure.
Of child caregivers who have used telemedicine, 75% of reported their telemedicine experience was better than an in-person visit, according to the survey. Convenience, after-hours accessibility, and immediacy were the top three reasons caregivers sought an online visit for their child. Compared with a similar survey conducted by Nemours in 2014, parents’ use of telemedicine for their children has grown by 125% and awareness of the practice has increased by 88%, the study found.
The overall takeaway is that parents are using telemedicine because of its ease and accessibility and they’re having satisfactory experiences with the technology, said Shayan Vyas, MD, a pediatrician based in Nemours’ Orlando location and director of telemedicine for Nemours Children’s Hospital.
“Parents are citing telemedicine because of convenience and that’s true for other industries that have gone mobile,” Dr. Vyas said in an interview. “We no longer hail a cab at the intersection, we use our smartphones. We now use Amazon and other companies to order diapers and other everyday items. ... More and more, patients are driving telemedicine more than the systems or the providers.”
Caregivers surveyed said they are most willing to use telehealth services for cold and flu (58%), pink eye (51%), and rashes (48%) as well as well-child visits (41%). However, parents and caregivers were hesitant to use telemedicine for chronic conditions and reported they would likely never consider telehealth services for diabetes (53%), asthma (43%), ear pain (37%), and ADHD (36%).
The findings are expected because there are limitations for providers when it comes to treating some conditions and chronic diseases with telemedicine, Dr. Vyas said. He also stressed that telemedicine should not be used to replace the medical home for children.
“We’re working really hard to ensure there’s great pediatric care online and that the medical home stays intact,” he said. “We don’t want telemedicine to become the wild wild west of retail clinics where children are getting care from providers they don’t know or who are not in touch with their primary care world.”
Nemours has incorporated telemedicine throughout its health system with direct-to-consumer care for acute, chronic, and postsurgical appointments. The telehealth program, called Nemours CareConnect, is a 24/7, on-demand pediatric service that provides access to Nemours pediatricians through smartphones, tablets, or computers. In addition, Nemours CareConnect is used to bring pediatric specialists into affiliated community hospitals.
“At Nemours, we’ve seen how telemedicine can positively impact patients’ lives,” Dr. Vyas said. “The overwhelmingly positive response we’ve seen from parents who are early adopters of telemedicine really reinforces the feasibility of online doctor visits and sets the stage for real change in the way health care is delivered.”
agallegos@frontlinemedcom.com
On Twitter @legal_med
Three-quarters of parents who have used telemedicine services for their children say the experience was better than an in-person office visit, according to a new study.
The analysis, released April 23, 2017, by Nemours Children’s Health System operating in five states, surveyed 500 child caregivers between February 15 and 20 about their awareness and usage of telemedicine services for their children aged 17 years and younger (mean age 10 years). Of caregivers surveyed, 15% had tried telemedicine services for their children, while another 61% reported they plan to use telemedicine in the next year for their children’s medical care, according to the study. Eight percent of caregivers did not plan to use telemedicine, and 31% of those surveyed were unsure.
Of child caregivers who have used telemedicine, 75% of reported their telemedicine experience was better than an in-person visit, according to the survey. Convenience, after-hours accessibility, and immediacy were the top three reasons caregivers sought an online visit for their child. Compared with a similar survey conducted by Nemours in 2014, parents’ use of telemedicine for their children has grown by 125% and awareness of the practice has increased by 88%, the study found.
The overall takeaway is that parents are using telemedicine because of its ease and accessibility and they’re having satisfactory experiences with the technology, said Shayan Vyas, MD, a pediatrician based in Nemours’ Orlando location and director of telemedicine for Nemours Children’s Hospital.
“Parents are citing telemedicine because of convenience and that’s true for other industries that have gone mobile,” Dr. Vyas said in an interview. “We no longer hail a cab at the intersection, we use our smartphones. We now use Amazon and other companies to order diapers and other everyday items. ... More and more, patients are driving telemedicine more than the systems or the providers.”
Caregivers surveyed said they are most willing to use telehealth services for cold and flu (58%), pink eye (51%), and rashes (48%) as well as well-child visits (41%). However, parents and caregivers were hesitant to use telemedicine for chronic conditions and reported they would likely never consider telehealth services for diabetes (53%), asthma (43%), ear pain (37%), and ADHD (36%).
The findings are expected because there are limitations for providers when it comes to treating some conditions and chronic diseases with telemedicine, Dr. Vyas said. He also stressed that telemedicine should not be used to replace the medical home for children.
“We’re working really hard to ensure there’s great pediatric care online and that the medical home stays intact,” he said. “We don’t want telemedicine to become the wild wild west of retail clinics where children are getting care from providers they don’t know or who are not in touch with their primary care world.”
Nemours has incorporated telemedicine throughout its health system with direct-to-consumer care for acute, chronic, and postsurgical appointments. The telehealth program, called Nemours CareConnect, is a 24/7, on-demand pediatric service that provides access to Nemours pediatricians through smartphones, tablets, or computers. In addition, Nemours CareConnect is used to bring pediatric specialists into affiliated community hospitals.
“At Nemours, we’ve seen how telemedicine can positively impact patients’ lives,” Dr. Vyas said. “The overwhelmingly positive response we’ve seen from parents who are early adopters of telemedicine really reinforces the feasibility of online doctor visits and sets the stage for real change in the way health care is delivered.”
agallegos@frontlinemedcom.com
On Twitter @legal_med
Prognostic tool may allow tailored therapy for Hodgkin lymphoma
A newly developed “robust and inexpensive” prognostic tool, the Childhood Hodgkin International Prognostic Score (CHIPS), may allow better tailoring of therapy at the time of diagnosis for children and adolescents who have intermediate-risk Hodgkin lymphoma.
Researchers in the Children’s Oncology Group first assessed 562 patients receiving uniform standard treatment to identify which risk factors present at diagnosis best predicted response to therapy, and used them to develop the prognostic score. They considered such factors as patient age, the number of involved sites, hemoglobin level, albumin level, erythrocyte sedimentation rate, the presence or absence of a large mediastinal mass, nodal involvement, the total bulk of disease, and the presence or absence of B symptoms (fever, weight loss, and/or night sweats). The final CHIPS prognostic tool included four predictors of poor event-free survival that are easily ascertained at diagnosis: stage IV disease, a large mediastinal mass (one with a tumor to thoracic diameter ratio over 0.33), the presence of fever, and hypoalbuminemia (a level of less than 3.5 g/dL).
The investigators then confirmed the accuracy of that score in a validation cohort of 541 patients from the United States, Canada, Switzerland, Australia, New Zealand, the Netherlands, and Israel. All the study participants received four cycles of doxorubicin, bleomycin, vincristine, and etoposide (ABVE) with prednisone and cyclophosphamide (PC), followed by involved-field radiation therapy, said Cindy L. Schwartz, MD, of the division of pediatrics, University of Texas MD Anderson Cancer Center, Houston, and her associates.
Patients who had low a CHIPS of 0 or 1 had excellent 4-year event-free survival (93% and 89%, respectively), while patients with a high CHIPS of 2 or 3 had poorer 4-year event-free survival (78% and 69%, respectively). These findings remained consistent across all subgroups of patients, regardless of whether the tumors had nodular sclerosis histology or mixed cellular histology (Pediatr Blood Cancer. 2017 Apr;64[4]).
The study results suggest that patients with CHIPS 2 or 3 could be considered for high-risk Hodgkin lymphoma treatment such as higher-dose cyclophosphamide or the addition of brentuximab vedotin, while those with a CHIPS 0 or 1 could be considered for less aggressive treatment such as foregoing or reducing radiation therapy, Dr. Schwartz and her associates said.
This study was supported by a grant from the National Cancer Institute to the Children’s Oncology Group. Dr. Schwartz and her associates reported having no relevant financial disclosures.
A newly developed “robust and inexpensive” prognostic tool, the Childhood Hodgkin International Prognostic Score (CHIPS), may allow better tailoring of therapy at the time of diagnosis for children and adolescents who have intermediate-risk Hodgkin lymphoma.
Researchers in the Children’s Oncology Group first assessed 562 patients receiving uniform standard treatment to identify which risk factors present at diagnosis best predicted response to therapy, and used them to develop the prognostic score. They considered such factors as patient age, the number of involved sites, hemoglobin level, albumin level, erythrocyte sedimentation rate, the presence or absence of a large mediastinal mass, nodal involvement, the total bulk of disease, and the presence or absence of B symptoms (fever, weight loss, and/or night sweats). The final CHIPS prognostic tool included four predictors of poor event-free survival that are easily ascertained at diagnosis: stage IV disease, a large mediastinal mass (one with a tumor to thoracic diameter ratio over 0.33), the presence of fever, and hypoalbuminemia (a level of less than 3.5 g/dL).
The investigators then confirmed the accuracy of that score in a validation cohort of 541 patients from the United States, Canada, Switzerland, Australia, New Zealand, the Netherlands, and Israel. All the study participants received four cycles of doxorubicin, bleomycin, vincristine, and etoposide (ABVE) with prednisone and cyclophosphamide (PC), followed by involved-field radiation therapy, said Cindy L. Schwartz, MD, of the division of pediatrics, University of Texas MD Anderson Cancer Center, Houston, and her associates.
Patients who had low a CHIPS of 0 or 1 had excellent 4-year event-free survival (93% and 89%, respectively), while patients with a high CHIPS of 2 or 3 had poorer 4-year event-free survival (78% and 69%, respectively). These findings remained consistent across all subgroups of patients, regardless of whether the tumors had nodular sclerosis histology or mixed cellular histology (Pediatr Blood Cancer. 2017 Apr;64[4]).
The study results suggest that patients with CHIPS 2 or 3 could be considered for high-risk Hodgkin lymphoma treatment such as higher-dose cyclophosphamide or the addition of brentuximab vedotin, while those with a CHIPS 0 or 1 could be considered for less aggressive treatment such as foregoing or reducing radiation therapy, Dr. Schwartz and her associates said.
This study was supported by a grant from the National Cancer Institute to the Children’s Oncology Group. Dr. Schwartz and her associates reported having no relevant financial disclosures.
A newly developed “robust and inexpensive” prognostic tool, the Childhood Hodgkin International Prognostic Score (CHIPS), may allow better tailoring of therapy at the time of diagnosis for children and adolescents who have intermediate-risk Hodgkin lymphoma.
Researchers in the Children’s Oncology Group first assessed 562 patients receiving uniform standard treatment to identify which risk factors present at diagnosis best predicted response to therapy, and used them to develop the prognostic score. They considered such factors as patient age, the number of involved sites, hemoglobin level, albumin level, erythrocyte sedimentation rate, the presence or absence of a large mediastinal mass, nodal involvement, the total bulk of disease, and the presence or absence of B symptoms (fever, weight loss, and/or night sweats). The final CHIPS prognostic tool included four predictors of poor event-free survival that are easily ascertained at diagnosis: stage IV disease, a large mediastinal mass (one with a tumor to thoracic diameter ratio over 0.33), the presence of fever, and hypoalbuminemia (a level of less than 3.5 g/dL).
The investigators then confirmed the accuracy of that score in a validation cohort of 541 patients from the United States, Canada, Switzerland, Australia, New Zealand, the Netherlands, and Israel. All the study participants received four cycles of doxorubicin, bleomycin, vincristine, and etoposide (ABVE) with prednisone and cyclophosphamide (PC), followed by involved-field radiation therapy, said Cindy L. Schwartz, MD, of the division of pediatrics, University of Texas MD Anderson Cancer Center, Houston, and her associates.
Patients who had low a CHIPS of 0 or 1 had excellent 4-year event-free survival (93% and 89%, respectively), while patients with a high CHIPS of 2 or 3 had poorer 4-year event-free survival (78% and 69%, respectively). These findings remained consistent across all subgroups of patients, regardless of whether the tumors had nodular sclerosis histology or mixed cellular histology (Pediatr Blood Cancer. 2017 Apr;64[4]).
The study results suggest that patients with CHIPS 2 or 3 could be considered for high-risk Hodgkin lymphoma treatment such as higher-dose cyclophosphamide or the addition of brentuximab vedotin, while those with a CHIPS 0 or 1 could be considered for less aggressive treatment such as foregoing or reducing radiation therapy, Dr. Schwartz and her associates said.
This study was supported by a grant from the National Cancer Institute to the Children’s Oncology Group. Dr. Schwartz and her associates reported having no relevant financial disclosures.
Key clinical point: A newly developed “robust and inexpensive” prognostic tool, the Childhood Hodgkin International Prognostic Score, or CHIPS, may allow more tailored therapy for children and adolescents who have intermediate-risk Hodgkin lymphoma.
Major finding: Patients who had a low CHIPS of 0 or 1 had excellent 4-year event-free survival (93.1% and 88.5%, respectively), while patients with a high CHIPS of 2 or 3 had poorer 4-year event-free survival (77.6% and 69.2%).
Data source: A cohort study to develop (in 562 patients) and validate (in 541 patients) a score for predicting the response to standard treatment in pediatric Hodgkin lymphoma.
Disclosures: This study was supported by a grant from the National Cancer Institute to the Children’s Oncology Group. Dr. Schwartz and her associates reported having no relevant financial disclosures.
Preterm infants face increased pertussis risk
Pertussis is more likely in infants who are born prematurely, compared with infants carried to term, according to Dr. Øystein Rolandsen Riise of the Norwegian Institute of Public Health, Oslo, and associates.
Using data from the Medical Birth Registry of Norway, 713,166 children were monitored until the age of 2 years from 1998 to 2010, during which time 968 cases of pertussis were laboratory confirmed. The incidence rate in term infants was 67.9 cases per 100,000 person-years, and was 115.2 cases per 100,000 person-years for preterm infants. The overall incidence rate ratio (IRR) of pertussis for preterm infants was 1.65, compared with term infants.
Hospitalization due to pertussis also was significantly more likely in preterm infants, with an overall IRR of 1.99, and infants born at 23-27 weeks again faced a greatly increased risk, with an IRR of 5.28.
Three-dose vaccine effectiveness against reported pertussis was 88.8% in term infants and 93% in preterm infants.
“Early and timely pediatric vaccinations as well as other strategies to prevent transmission to preterm infants are of utmost importance,” the investigators wrote.
Find the full study in the Pediatric Infectious Disease Journal (2017 May. doi: 10.1097/INF.0000000000001545).
Pertussis is more likely in infants who are born prematurely, compared with infants carried to term, according to Dr. Øystein Rolandsen Riise of the Norwegian Institute of Public Health, Oslo, and associates.
Using data from the Medical Birth Registry of Norway, 713,166 children were monitored until the age of 2 years from 1998 to 2010, during which time 968 cases of pertussis were laboratory confirmed. The incidence rate in term infants was 67.9 cases per 100,000 person-years, and was 115.2 cases per 100,000 person-years for preterm infants. The overall incidence rate ratio (IRR) of pertussis for preterm infants was 1.65, compared with term infants.
Hospitalization due to pertussis also was significantly more likely in preterm infants, with an overall IRR of 1.99, and infants born at 23-27 weeks again faced a greatly increased risk, with an IRR of 5.28.
Three-dose vaccine effectiveness against reported pertussis was 88.8% in term infants and 93% in preterm infants.
“Early and timely pediatric vaccinations as well as other strategies to prevent transmission to preterm infants are of utmost importance,” the investigators wrote.
Find the full study in the Pediatric Infectious Disease Journal (2017 May. doi: 10.1097/INF.0000000000001545).
Pertussis is more likely in infants who are born prematurely, compared with infants carried to term, according to Dr. Øystein Rolandsen Riise of the Norwegian Institute of Public Health, Oslo, and associates.
Using data from the Medical Birth Registry of Norway, 713,166 children were monitored until the age of 2 years from 1998 to 2010, during which time 968 cases of pertussis were laboratory confirmed. The incidence rate in term infants was 67.9 cases per 100,000 person-years, and was 115.2 cases per 100,000 person-years for preterm infants. The overall incidence rate ratio (IRR) of pertussis for preterm infants was 1.65, compared with term infants.
Hospitalization due to pertussis also was significantly more likely in preterm infants, with an overall IRR of 1.99, and infants born at 23-27 weeks again faced a greatly increased risk, with an IRR of 5.28.
Three-dose vaccine effectiveness against reported pertussis was 88.8% in term infants and 93% in preterm infants.
“Early and timely pediatric vaccinations as well as other strategies to prevent transmission to preterm infants are of utmost importance,” the investigators wrote.
Find the full study in the Pediatric Infectious Disease Journal (2017 May. doi: 10.1097/INF.0000000000001545).
Dealing with stealing
A 7-year-old boy, Jacob, with a history of ADHD and frequent impulsive behavior, takes a calculator from another child’s desk. About 3 months before, he had come home after taking another child’s action figure. His parents have been working on parent training for ADHD, but don’t know how to respond to this behavior and are very upset at their son.
Discussion
Stealing is an issue of serious concern to parents. To understand how common this is in younger children, researchers need to rely on the reports of parents and teachers, which may be underestimates of the problem because stealing is usually a hidden or covert behavior. Research on older youth can include anonymous self-reports.
Stealing and dishonesty are such disappointing behaviors to adults that it is tempting to resort to harsh punishments, long lectures, or harshly disparaging words. But these kinds of punishments backfire. The goal is an overall positive relationship and a calm consistent response to undesired behaviors. Parents often need support in how to be positive with a child who is frustrating them. Taking 15 minutes a day to do some activity a child likes – playing catch, playing a board game, cooking together, or doing crafts – all while noticing the positive things a child is doing rather than teaching, criticizing, or grilling a child on what happened in school sets a happier tone to the relationship, which is a background for any discipline. Jacob’s parents had already been working on this through their parent training class, but it helped to encourage them to keep doing this.
Because of the covert nature of stealing, it is sometimes hard to know where an item has come from, and children are likely to lie about this, saying that a friend gave it to them or they found it. To avoid this, when working with a child who has been stealing, the expectation should be made clear in advance that it is the child’s responsibility to avoid suspicion by having nothing in his possession that is not known to the adult. It is important to avoid back and forth arguments. The adult’s decision is final. With frequent stealing, it is helpful to make an inventory of the child’s possessions as a baseline.
When it comes to consequences, the important thing is to be sure that they are consistent and predictable. Returning an item to the owner and apologizing are logical. Another excellent type of consequence for behaviors that happen rarely is an extra work chore of about half an hour.
So a parent might say something like, “Jacob, we know that a stealing monster has been getting you, and we want to fight against him. I have made up a list of everything you have right now, and it is going to be your responsibility to make sure you don’t bring home anything else. So that means even if you find something or someone gives you something, you shouldn’t take it. If I find anything that isn’t on the list, you are going to have to return it to the person it belongs to and apologize, and then do an extra work chore for half an hour. A habit can be hard to change, but I know we can do it together. Let’s go play catch.” Then when the child is found with something in his possession, the adult should remain calm, avoid a lecture, and just say something like, “Jacob, this is something that doesn’t belong to you. You need to return it to the person it belongs to, and you have an extra half hour of raking leaves. No TV until the leaves are done.” The parent also should be alert to opportunities to attend to or praise behaviors like the child saving money to spend on things he wants, or asking to borrow things from other family members rather than just taking them.
Stealing can be a tough problem and often goes along with other rule-breaking behavior. If a parent is struggling to stay calm and find the positive, referral to group or individual parent training through programs like the Incredible Years or Triple P can give a parent the chance to learn and practice skills step by step.
As children enter their teen years, stealing becomes much more common, and can be reinforced by peers as well as by the action itself. The same principles of finding positive activities, continuing positive interactions with parents, and predictable and consistent – rather than harsh – consequences continue to apply, but may require additional supports. Larger programs such as Multisystemic Therapy, which works with families, peers, and communities, have been demonstrated to be effective for young people with juvenile delinquency.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures.
Resource
Stealing, in “Children’s needs III: Development, prevention, and intervention,” (Washington: National Association of School Psychologists, 2006, pp. 171-83).
A 7-year-old boy, Jacob, with a history of ADHD and frequent impulsive behavior, takes a calculator from another child’s desk. About 3 months before, he had come home after taking another child’s action figure. His parents have been working on parent training for ADHD, but don’t know how to respond to this behavior and are very upset at their son.
Discussion
Stealing is an issue of serious concern to parents. To understand how common this is in younger children, researchers need to rely on the reports of parents and teachers, which may be underestimates of the problem because stealing is usually a hidden or covert behavior. Research on older youth can include anonymous self-reports.
Stealing and dishonesty are such disappointing behaviors to adults that it is tempting to resort to harsh punishments, long lectures, or harshly disparaging words. But these kinds of punishments backfire. The goal is an overall positive relationship and a calm consistent response to undesired behaviors. Parents often need support in how to be positive with a child who is frustrating them. Taking 15 minutes a day to do some activity a child likes – playing catch, playing a board game, cooking together, or doing crafts – all while noticing the positive things a child is doing rather than teaching, criticizing, or grilling a child on what happened in school sets a happier tone to the relationship, which is a background for any discipline. Jacob’s parents had already been working on this through their parent training class, but it helped to encourage them to keep doing this.
Because of the covert nature of stealing, it is sometimes hard to know where an item has come from, and children are likely to lie about this, saying that a friend gave it to them or they found it. To avoid this, when working with a child who has been stealing, the expectation should be made clear in advance that it is the child’s responsibility to avoid suspicion by having nothing in his possession that is not known to the adult. It is important to avoid back and forth arguments. The adult’s decision is final. With frequent stealing, it is helpful to make an inventory of the child’s possessions as a baseline.
When it comes to consequences, the important thing is to be sure that they are consistent and predictable. Returning an item to the owner and apologizing are logical. Another excellent type of consequence for behaviors that happen rarely is an extra work chore of about half an hour.
So a parent might say something like, “Jacob, we know that a stealing monster has been getting you, and we want to fight against him. I have made up a list of everything you have right now, and it is going to be your responsibility to make sure you don’t bring home anything else. So that means even if you find something or someone gives you something, you shouldn’t take it. If I find anything that isn’t on the list, you are going to have to return it to the person it belongs to and apologize, and then do an extra work chore for half an hour. A habit can be hard to change, but I know we can do it together. Let’s go play catch.” Then when the child is found with something in his possession, the adult should remain calm, avoid a lecture, and just say something like, “Jacob, this is something that doesn’t belong to you. You need to return it to the person it belongs to, and you have an extra half hour of raking leaves. No TV until the leaves are done.” The parent also should be alert to opportunities to attend to or praise behaviors like the child saving money to spend on things he wants, or asking to borrow things from other family members rather than just taking them.
Stealing can be a tough problem and often goes along with other rule-breaking behavior. If a parent is struggling to stay calm and find the positive, referral to group or individual parent training through programs like the Incredible Years or Triple P can give a parent the chance to learn and practice skills step by step.
As children enter their teen years, stealing becomes much more common, and can be reinforced by peers as well as by the action itself. The same principles of finding positive activities, continuing positive interactions with parents, and predictable and consistent – rather than harsh – consequences continue to apply, but may require additional supports. Larger programs such as Multisystemic Therapy, which works with families, peers, and communities, have been demonstrated to be effective for young people with juvenile delinquency.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures.
Resource
Stealing, in “Children’s needs III: Development, prevention, and intervention,” (Washington: National Association of School Psychologists, 2006, pp. 171-83).
A 7-year-old boy, Jacob, with a history of ADHD and frequent impulsive behavior, takes a calculator from another child’s desk. About 3 months before, he had come home after taking another child’s action figure. His parents have been working on parent training for ADHD, but don’t know how to respond to this behavior and are very upset at their son.
Discussion
Stealing is an issue of serious concern to parents. To understand how common this is in younger children, researchers need to rely on the reports of parents and teachers, which may be underestimates of the problem because stealing is usually a hidden or covert behavior. Research on older youth can include anonymous self-reports.
Stealing and dishonesty are such disappointing behaviors to adults that it is tempting to resort to harsh punishments, long lectures, or harshly disparaging words. But these kinds of punishments backfire. The goal is an overall positive relationship and a calm consistent response to undesired behaviors. Parents often need support in how to be positive with a child who is frustrating them. Taking 15 minutes a day to do some activity a child likes – playing catch, playing a board game, cooking together, or doing crafts – all while noticing the positive things a child is doing rather than teaching, criticizing, or grilling a child on what happened in school sets a happier tone to the relationship, which is a background for any discipline. Jacob’s parents had already been working on this through their parent training class, but it helped to encourage them to keep doing this.
Because of the covert nature of stealing, it is sometimes hard to know where an item has come from, and children are likely to lie about this, saying that a friend gave it to them or they found it. To avoid this, when working with a child who has been stealing, the expectation should be made clear in advance that it is the child’s responsibility to avoid suspicion by having nothing in his possession that is not known to the adult. It is important to avoid back and forth arguments. The adult’s decision is final. With frequent stealing, it is helpful to make an inventory of the child’s possessions as a baseline.
When it comes to consequences, the important thing is to be sure that they are consistent and predictable. Returning an item to the owner and apologizing are logical. Another excellent type of consequence for behaviors that happen rarely is an extra work chore of about half an hour.
So a parent might say something like, “Jacob, we know that a stealing monster has been getting you, and we want to fight against him. I have made up a list of everything you have right now, and it is going to be your responsibility to make sure you don’t bring home anything else. So that means even if you find something or someone gives you something, you shouldn’t take it. If I find anything that isn’t on the list, you are going to have to return it to the person it belongs to and apologize, and then do an extra work chore for half an hour. A habit can be hard to change, but I know we can do it together. Let’s go play catch.” Then when the child is found with something in his possession, the adult should remain calm, avoid a lecture, and just say something like, “Jacob, this is something that doesn’t belong to you. You need to return it to the person it belongs to, and you have an extra half hour of raking leaves. No TV until the leaves are done.” The parent also should be alert to opportunities to attend to or praise behaviors like the child saving money to spend on things he wants, or asking to borrow things from other family members rather than just taking them.
Stealing can be a tough problem and often goes along with other rule-breaking behavior. If a parent is struggling to stay calm and find the positive, referral to group or individual parent training through programs like the Incredible Years or Triple P can give a parent the chance to learn and practice skills step by step.
As children enter their teen years, stealing becomes much more common, and can be reinforced by peers as well as by the action itself. The same principles of finding positive activities, continuing positive interactions with parents, and predictable and consistent – rather than harsh – consequences continue to apply, but may require additional supports. Larger programs such as Multisystemic Therapy, which works with families, peers, and communities, have been demonstrated to be effective for young people with juvenile delinquency.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures.
Resource
Stealing, in “Children’s needs III: Development, prevention, and intervention,” (Washington: National Association of School Psychologists, 2006, pp. 171-83).
DTC genetic health risk tests: Beware
The Food and Drug Administration recently authorized 23andMe to provide consumers with results of germline DNA sequence variants associated with risk for 10 health conditions, among them hereditary hemochromatosis, alpha-1 antitrypsin deficiency, celiac disease, Alzheimer’s disease, and Parkinson’s disease. After they submit a saliva sample and pay a test fee, customers ordering the online test will receive a report delineating their ancestry markers and informing them whether they carry any of the genetic variants associated with selected health risks included on the targeted DNA sequencing panel.
As more consumers partake in “recreational genomic testing,” clinicians should understand the limitations of DTC genetic tests and should be prepared to discuss with patients why these should not supersede clinical diagnostic evaluations.
Dr. Stoffel is a gastroenterologist, assistant professor of internal medicine, and director of the cancer genetics clinic at the University of Michigan, Ann Arbor. She has no disclosures.
The Food and Drug Administration recently authorized 23andMe to provide consumers with results of germline DNA sequence variants associated with risk for 10 health conditions, among them hereditary hemochromatosis, alpha-1 antitrypsin deficiency, celiac disease, Alzheimer’s disease, and Parkinson’s disease. After they submit a saliva sample and pay a test fee, customers ordering the online test will receive a report delineating their ancestry markers and informing them whether they carry any of the genetic variants associated with selected health risks included on the targeted DNA sequencing panel.
As more consumers partake in “recreational genomic testing,” clinicians should understand the limitations of DTC genetic tests and should be prepared to discuss with patients why these should not supersede clinical diagnostic evaluations.
Dr. Stoffel is a gastroenterologist, assistant professor of internal medicine, and director of the cancer genetics clinic at the University of Michigan, Ann Arbor. She has no disclosures.
The Food and Drug Administration recently authorized 23andMe to provide consumers with results of germline DNA sequence variants associated with risk for 10 health conditions, among them hereditary hemochromatosis, alpha-1 antitrypsin deficiency, celiac disease, Alzheimer’s disease, and Parkinson’s disease. After they submit a saliva sample and pay a test fee, customers ordering the online test will receive a report delineating their ancestry markers and informing them whether they carry any of the genetic variants associated with selected health risks included on the targeted DNA sequencing panel.
As more consumers partake in “recreational genomic testing,” clinicians should understand the limitations of DTC genetic tests and should be prepared to discuss with patients why these should not supersede clinical diagnostic evaluations.
Dr. Stoffel is a gastroenterologist, assistant professor of internal medicine, and director of the cancer genetics clinic at the University of Michigan, Ann Arbor. She has no disclosures.
Revaccinate HIV-infected teens with hepatitis B vaccine
Consider revaccinating all perinatally HIV-infected adolescents who did not initiate highly active antiretroviral therapy (HAART) at the time of initial infant hepatitis B virus (HBV) vaccination, with a three-dose HBV schedule, recommended researchers at Mahidol University, Bangkok, in a recent study.
In a prospective study from March 2012 to March 2014 ultimately involving 162 perinatally HIV-infected adolescents with immune reconstitution, only 3.6% were receiving HAART at the time of initial infant HBV vaccination and 96.3% had undetectable antihepatitis B surface antibodies (anti-HBs) at baseline. Adolescents with breakthrough HBV infection had been excluded from the cohort.
In a multivariate analysis, there was no independent factor that was associated with the presence of immune memory defined as anti-HBs greater than or equal to 100 mIU/mL, wrote lead researcher Keswadee Lapphra, MD, and her associates.
In a previous study, 71% of three-dose revaccinated persons retained protective antibodies against HBV at 3-year follow-up; this was a similar rate to that reported in healthy HIV-infected children after their infant primary HBV series (Vaccine. 2011 May 23;29[23]:3977-81), they said.
Read more at (Ped Inf Dis J. 2017. doi: 10.1097/inf.0000000000001613).
Consider revaccinating all perinatally HIV-infected adolescents who did not initiate highly active antiretroviral therapy (HAART) at the time of initial infant hepatitis B virus (HBV) vaccination, with a three-dose HBV schedule, recommended researchers at Mahidol University, Bangkok, in a recent study.
In a prospective study from March 2012 to March 2014 ultimately involving 162 perinatally HIV-infected adolescents with immune reconstitution, only 3.6% were receiving HAART at the time of initial infant HBV vaccination and 96.3% had undetectable antihepatitis B surface antibodies (anti-HBs) at baseline. Adolescents with breakthrough HBV infection had been excluded from the cohort.
In a multivariate analysis, there was no independent factor that was associated with the presence of immune memory defined as anti-HBs greater than or equal to 100 mIU/mL, wrote lead researcher Keswadee Lapphra, MD, and her associates.
In a previous study, 71% of three-dose revaccinated persons retained protective antibodies against HBV at 3-year follow-up; this was a similar rate to that reported in healthy HIV-infected children after their infant primary HBV series (Vaccine. 2011 May 23;29[23]:3977-81), they said.
Read more at (Ped Inf Dis J. 2017. doi: 10.1097/inf.0000000000001613).
Consider revaccinating all perinatally HIV-infected adolescents who did not initiate highly active antiretroviral therapy (HAART) at the time of initial infant hepatitis B virus (HBV) vaccination, with a three-dose HBV schedule, recommended researchers at Mahidol University, Bangkok, in a recent study.
In a prospective study from March 2012 to March 2014 ultimately involving 162 perinatally HIV-infected adolescents with immune reconstitution, only 3.6% were receiving HAART at the time of initial infant HBV vaccination and 96.3% had undetectable antihepatitis B surface antibodies (anti-HBs) at baseline. Adolescents with breakthrough HBV infection had been excluded from the cohort.
In a multivariate analysis, there was no independent factor that was associated with the presence of immune memory defined as anti-HBs greater than or equal to 100 mIU/mL, wrote lead researcher Keswadee Lapphra, MD, and her associates.
In a previous study, 71% of three-dose revaccinated persons retained protective antibodies against HBV at 3-year follow-up; this was a similar rate to that reported in healthy HIV-infected children after their infant primary HBV series (Vaccine. 2011 May 23;29[23]:3977-81), they said.
Read more at (Ped Inf Dis J. 2017. doi: 10.1097/inf.0000000000001613).
FROM THE PEDIATRIC INFECTIOUS DISEASE JOURNAL
FDA warns against use of codeine, tramadol in children
The Food and Drug Administration is restricting the use of two opiates – codeine and tramadol – in children, and also warns they are potentially dangerous to infants of breastfeeding women.
Codeine is approved to treat pain and cough; tramadol is approved to treat pain.
“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Douglas Throckmorton, MD, the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, said in a statement.
In 2013, the FDA updated prescription codeine labeling to contain a boxed warning and contraindication for children up to age 18 years regarding the risk of slowed breathing from codeine prescribed after tonsillectomy and/or adenoidectomy. And in 2015, the agency issued warnings about the risk of serious breathing problems in children who had ultrarapid metabolism of codeine and tramadol.
In the current safety statement, the FDA said it will require additional labeling changes, including contraindications for use of codeine or tramadol in all children younger than 12 years of age and a new contraindication for tramadol in children younger than 18 years being treated for pain after tonsillectomy and/or adenoidectomy, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.
Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults, the agency noted.
The agency cited particular concerns over those who are “ultra-rapid metabolizers” of substrates of the cytochrome P450 isoenzyme 2D6 (CYP2D6) genotype. These people more quickly convert codeine into potentially dangerously high levels of morphine, which can lead to fatal respiratory depression.
Supporting the restrictions and warning were data on 64 cases of respiratory depression that occurred worldwide between 1969 and 2015, when a codeine-based medicine was used in children younger than 18 years. Twenty-four of these children died.
The most frequently cited medicines in the cases were acetaminophen with codeine and promethazine with codeine with or without phenylephrine, either given to soothe postoperative pain, general pain, sore or strep throat pain, or cough and cold.
Ten of the 64 cases implicated the CYP2D6 genotype. Seven of the patients were “ultrarapid metabolizers,” five of whom died.
Data cited on tramadol included nine worldwide cases of tramadol-related respiratory depression occurring between 1969 and 2016, resulting in the deaths of three children, all under the age of 6 years, and all of whom were taking the drug for postoperative pain or fever.
All but one case of respiratory depression occurred within the first 24 hours of taking the drug. One of the patients was genotyped for CYP2D6, and found to have three functional alleles consistent with ultrarapid metabolism.
Mothers who are ultrarapid metabolizers of codeine can have high levels of morphine in their breast milk that are dangerous to their breastfed infants, whereas there is less of a threat posed by women with normal codeine metabolism because the amount of codeine secreted into the breast milk is low and dose dependent.
The FDA stated that data reveal numerous reports of respiratory depression and at least one death in infants of breastfeeding mothers taking these medicines, particularly mothers with the CYP2D6 genotype. Although there are FDA-cleared tests for ultrarapid metabolism, they are not commonly used.
The agency stated that breastfeeding women taking any opioid pain medicine, including codeine or tramadol should contact their health care provider if they notice the infant is sleeping more than 4 hours at a time, or if the infant is having difficulty breastfeeding or seems limp.
Clinicians are urged to report side effects that occur while using codeine or tramadol to the FDA’s MedWatch Adverse Event Reporting program.
The Food and Drug Administration is restricting the use of two opiates – codeine and tramadol – in children, and also warns they are potentially dangerous to infants of breastfeeding women.
Codeine is approved to treat pain and cough; tramadol is approved to treat pain.
“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Douglas Throckmorton, MD, the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, said in a statement.
In 2013, the FDA updated prescription codeine labeling to contain a boxed warning and contraindication for children up to age 18 years regarding the risk of slowed breathing from codeine prescribed after tonsillectomy and/or adenoidectomy. And in 2015, the agency issued warnings about the risk of serious breathing problems in children who had ultrarapid metabolism of codeine and tramadol.
In the current safety statement, the FDA said it will require additional labeling changes, including contraindications for use of codeine or tramadol in all children younger than 12 years of age and a new contraindication for tramadol in children younger than 18 years being treated for pain after tonsillectomy and/or adenoidectomy, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.
Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults, the agency noted.
The agency cited particular concerns over those who are “ultra-rapid metabolizers” of substrates of the cytochrome P450 isoenzyme 2D6 (CYP2D6) genotype. These people more quickly convert codeine into potentially dangerously high levels of morphine, which can lead to fatal respiratory depression.
Supporting the restrictions and warning were data on 64 cases of respiratory depression that occurred worldwide between 1969 and 2015, when a codeine-based medicine was used in children younger than 18 years. Twenty-four of these children died.
The most frequently cited medicines in the cases were acetaminophen with codeine and promethazine with codeine with or without phenylephrine, either given to soothe postoperative pain, general pain, sore or strep throat pain, or cough and cold.
Ten of the 64 cases implicated the CYP2D6 genotype. Seven of the patients were “ultrarapid metabolizers,” five of whom died.
Data cited on tramadol included nine worldwide cases of tramadol-related respiratory depression occurring between 1969 and 2016, resulting in the deaths of three children, all under the age of 6 years, and all of whom were taking the drug for postoperative pain or fever.
All but one case of respiratory depression occurred within the first 24 hours of taking the drug. One of the patients was genotyped for CYP2D6, and found to have three functional alleles consistent with ultrarapid metabolism.
Mothers who are ultrarapid metabolizers of codeine can have high levels of morphine in their breast milk that are dangerous to their breastfed infants, whereas there is less of a threat posed by women with normal codeine metabolism because the amount of codeine secreted into the breast milk is low and dose dependent.
The FDA stated that data reveal numerous reports of respiratory depression and at least one death in infants of breastfeeding mothers taking these medicines, particularly mothers with the CYP2D6 genotype. Although there are FDA-cleared tests for ultrarapid metabolism, they are not commonly used.
The agency stated that breastfeeding women taking any opioid pain medicine, including codeine or tramadol should contact their health care provider if they notice the infant is sleeping more than 4 hours at a time, or if the infant is having difficulty breastfeeding or seems limp.
Clinicians are urged to report side effects that occur while using codeine or tramadol to the FDA’s MedWatch Adverse Event Reporting program.
The Food and Drug Administration is restricting the use of two opiates – codeine and tramadol – in children, and also warns they are potentially dangerous to infants of breastfeeding women.
Codeine is approved to treat pain and cough; tramadol is approved to treat pain.
“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Douglas Throckmorton, MD, the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, said in a statement.
In 2013, the FDA updated prescription codeine labeling to contain a boxed warning and contraindication for children up to age 18 years regarding the risk of slowed breathing from codeine prescribed after tonsillectomy and/or adenoidectomy. And in 2015, the agency issued warnings about the risk of serious breathing problems in children who had ultrarapid metabolism of codeine and tramadol.
In the current safety statement, the FDA said it will require additional labeling changes, including contraindications for use of codeine or tramadol in all children younger than 12 years of age and a new contraindication for tramadol in children younger than 18 years being treated for pain after tonsillectomy and/or adenoidectomy, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.
Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults, the agency noted.
The agency cited particular concerns over those who are “ultra-rapid metabolizers” of substrates of the cytochrome P450 isoenzyme 2D6 (CYP2D6) genotype. These people more quickly convert codeine into potentially dangerously high levels of morphine, which can lead to fatal respiratory depression.
Supporting the restrictions and warning were data on 64 cases of respiratory depression that occurred worldwide between 1969 and 2015, when a codeine-based medicine was used in children younger than 18 years. Twenty-four of these children died.
The most frequently cited medicines in the cases were acetaminophen with codeine and promethazine with codeine with or without phenylephrine, either given to soothe postoperative pain, general pain, sore or strep throat pain, or cough and cold.
Ten of the 64 cases implicated the CYP2D6 genotype. Seven of the patients were “ultrarapid metabolizers,” five of whom died.
Data cited on tramadol included nine worldwide cases of tramadol-related respiratory depression occurring between 1969 and 2016, resulting in the deaths of three children, all under the age of 6 years, and all of whom were taking the drug for postoperative pain or fever.
All but one case of respiratory depression occurred within the first 24 hours of taking the drug. One of the patients was genotyped for CYP2D6, and found to have three functional alleles consistent with ultrarapid metabolism.
Mothers who are ultrarapid metabolizers of codeine can have high levels of morphine in their breast milk that are dangerous to their breastfed infants, whereas there is less of a threat posed by women with normal codeine metabolism because the amount of codeine secreted into the breast milk is low and dose dependent.
The FDA stated that data reveal numerous reports of respiratory depression and at least one death in infants of breastfeeding mothers taking these medicines, particularly mothers with the CYP2D6 genotype. Although there are FDA-cleared tests for ultrarapid metabolism, they are not commonly used.
The agency stated that breastfeeding women taking any opioid pain medicine, including codeine or tramadol should contact their health care provider if they notice the infant is sleeping more than 4 hours at a time, or if the infant is having difficulty breastfeeding or seems limp.
Clinicians are urged to report side effects that occur while using codeine or tramadol to the FDA’s MedWatch Adverse Event Reporting program.
Can high hematocrit predict early shunt thrombosis?
Shunt occlusion has been a well-documented cause of shunt failure in newborns who have had systemic to pulmonary shunt placement, and little has been known about why shunts occlude. However, researchers have reported in a small retrospective study that higher postoperative hematocrit levels immediately after surgery may be predictors of shunt occlusion.
Reporting in the April 2017 issue of The Journal of Thoracic and Cardiovascular Surgery, Brett R. Anderson, MD, of New York-Presbyterian/Morgan Stanley Children’s Hospital, Columbia University Medical Center in New York, and coauthors, found that every 5-point increase in postoperative hematocrit more than doubled an infant’s odds of having early shunt occlusion (J Thorac Cardiovasc Surg. 2017;153:947-55).
“Beginning in the latter half of 2014, we noticed an increase in the incidence of early shunt occlusions in our neonatal cardiac intensive care unit,” Dr. Anderson and coauthors said. So they conducted a retrospective chart review of 80 infants who had undergone systemic to pulmonary shunt placement from January 2010 to July 2015, hypothesizing that increased hematocrit in the early postoperative period might have caused early shunt occlusion. They investigated the association between the first postoperative hematocrit and early shunt occlusion and in-hospital mortality in these patients.
Five patients (6.3%) experienced early shunt occlusion – that is, within 24 hours of placement (actually, within 10 hours of placement). Overall, 12 infants (15%) experienced shunt occlusion. The physicians at New York-Presbyterian do not administer anticoagulation in these patients during the first 12 hours after shunt placement.
The median initial postoperative hematocrit was 41.7%, with a range of 31.7%-55.8%. The survival analysis the researchers performed found that for every 5 additional percentage points, the hazard ratio for early shunt occlusion was 2.7 (P = .007) and 1.74 for any shunt occlusion (P less than .001). Incidentally, four cases of early shunt occlusion occurred in the later study period after 2014, during which the average first postoperative hematocrit was significantly higher than in the pre-2014 study period, 45.3% vs. 41.5% (P = .21), and the odds of early shunt occlusion were 16 times higher (P less than .001). Dr. Anderson and coauthors said the possible explanation for this variation was a switch to a new point-of-care analyzer in 2013.
With regard to mortality, six infants overall (7.4%) died before discharge, and four (5%) within 30 days of shunt placement. No infants with early shunt occlusion died, although two with late shunt occlusion died. Increased inotrope score and first postoperative arterial oxygen tension were the only factors associated with increased mortality. “No significant association was identified between hematocrit and 30-day mortality,” Dr. Anderson and coauthors said.
In the first 24 hours after surgery, 11 infants (13.8%) received packed red blood cell (PRBC) transfusions, seven (8.8%) received platelets, and four (5%) received fresh frozen plasma/cryoprecipitate. Higher postoperative PRBC transfusion volumes were associated with increased odds of mortality (P = .001), but none of these factors were significantly associated with early shunt occlusion.
Dr. Anderson and coauthors acknowledged that shunt occlusion is a “vexing problem” in infants with cyanotic heart disease. While other researchers studied postoperative hematocrit levels and possible associations with outcomes, including shunt occlusion and mortality, the New York-Presbyterian investigators said this is the first study of the first postoperative hematocrit.
Dr. Anderson and coauthors said their findings raise the question about the ideal perioperative prophylactic antithrombotic therapy in these patients. These researchers initiate aspirin therapy 12 hours after surgery if hemostasis is established.
As a result of this study, Dr. Anderson and coauthors instituted a number of practice changes at their center. They include:
• Cardiac anesthesiologists have been asked not to transfuse shunted neonates with hematocrit level of greater than or equal to 35%, and hematocrits are then immediately repeated when a patient returns to the cardiac ICU.
• Patients with hematocrits greater than or equal to 55% get partial exchange transfusions.
• An individualized approach for patients with lower hematocrits who are more cyanotic than expected. This includes a diagnostic echocardiogram, nitric oxide, oxygen and heparin, escalated inotropic support if necessary and sometimes a cautious approach to transfusions if symptoms do not resolve and an acute shunt occlusion if not likely.
Dr. Anderson and coauthors acknowledged limits to their study, most notably its retrospective nature and a small population at a single center, and that large investigations are needed to validate their findings.
Dr. Anderson disclosed receiving salary support from the National Center for Advancing Translational Sciences. Coauthor Jennifer M. Duchon, MDCM, MPH, receives salary support from the National Institute of Allergy and Infectious Disease. The remaining coauthors had no financial relationships to disclose.
In her invited commentary, Nancy S. Ghanayem, MD, of the Medical College of Wisconsin, gives credit to Dr. Anderson and coauthors for introducing the notion that high initial postoperative hematocrit may increase the risk of early shunt thrombosis in newborns, but with a caveat: “we remain somewhat hesitant regarding wholesale acceptance of the validity of the conclusions for several reasons” (J Thorac Cardiovasc Surg. 2017;153:956).
Those reasons include the low number of reported events, failure to list the actual hematocrits of the five patients who experienced early shunt occlusion and the lack of hemodynamic data – the latter of which she called “a significant limitation.”
A patient with low cardiac output, especially one who is cyanotic or has a single ventricle, is at higher risk for thrombosis and more likely to be transfused, “which in this case would potentially be masked by the method of comparing transfused volumes,” Dr. Ghanayem said. The inotrope score, while useful, is not a surrogate for actual cardiac output. She asks, “Accordingly, is early shunt occlusion due predominantly to passenger (corpuscular) overload or to a slow-moving train?”
Dr. Ghanayem had no financial relationships to disclose.
In her invited commentary, Nancy S. Ghanayem, MD, of the Medical College of Wisconsin, gives credit to Dr. Anderson and coauthors for introducing the notion that high initial postoperative hematocrit may increase the risk of early shunt thrombosis in newborns, but with a caveat: “we remain somewhat hesitant regarding wholesale acceptance of the validity of the conclusions for several reasons” (J Thorac Cardiovasc Surg. 2017;153:956).
Those reasons include the low number of reported events, failure to list the actual hematocrits of the five patients who experienced early shunt occlusion and the lack of hemodynamic data – the latter of which she called “a significant limitation.”
A patient with low cardiac output, especially one who is cyanotic or has a single ventricle, is at higher risk for thrombosis and more likely to be transfused, “which in this case would potentially be masked by the method of comparing transfused volumes,” Dr. Ghanayem said. The inotrope score, while useful, is not a surrogate for actual cardiac output. She asks, “Accordingly, is early shunt occlusion due predominantly to passenger (corpuscular) overload or to a slow-moving train?”
Dr. Ghanayem had no financial relationships to disclose.
In her invited commentary, Nancy S. Ghanayem, MD, of the Medical College of Wisconsin, gives credit to Dr. Anderson and coauthors for introducing the notion that high initial postoperative hematocrit may increase the risk of early shunt thrombosis in newborns, but with a caveat: “we remain somewhat hesitant regarding wholesale acceptance of the validity of the conclusions for several reasons” (J Thorac Cardiovasc Surg. 2017;153:956).
Those reasons include the low number of reported events, failure to list the actual hematocrits of the five patients who experienced early shunt occlusion and the lack of hemodynamic data – the latter of which she called “a significant limitation.”
A patient with low cardiac output, especially one who is cyanotic or has a single ventricle, is at higher risk for thrombosis and more likely to be transfused, “which in this case would potentially be masked by the method of comparing transfused volumes,” Dr. Ghanayem said. The inotrope score, while useful, is not a surrogate for actual cardiac output. She asks, “Accordingly, is early shunt occlusion due predominantly to passenger (corpuscular) overload or to a slow-moving train?”
Dr. Ghanayem had no financial relationships to disclose.
Shunt occlusion has been a well-documented cause of shunt failure in newborns who have had systemic to pulmonary shunt placement, and little has been known about why shunts occlude. However, researchers have reported in a small retrospective study that higher postoperative hematocrit levels immediately after surgery may be predictors of shunt occlusion.
Reporting in the April 2017 issue of The Journal of Thoracic and Cardiovascular Surgery, Brett R. Anderson, MD, of New York-Presbyterian/Morgan Stanley Children’s Hospital, Columbia University Medical Center in New York, and coauthors, found that every 5-point increase in postoperative hematocrit more than doubled an infant’s odds of having early shunt occlusion (J Thorac Cardiovasc Surg. 2017;153:947-55).
“Beginning in the latter half of 2014, we noticed an increase in the incidence of early shunt occlusions in our neonatal cardiac intensive care unit,” Dr. Anderson and coauthors said. So they conducted a retrospective chart review of 80 infants who had undergone systemic to pulmonary shunt placement from January 2010 to July 2015, hypothesizing that increased hematocrit in the early postoperative period might have caused early shunt occlusion. They investigated the association between the first postoperative hematocrit and early shunt occlusion and in-hospital mortality in these patients.
Five patients (6.3%) experienced early shunt occlusion – that is, within 24 hours of placement (actually, within 10 hours of placement). Overall, 12 infants (15%) experienced shunt occlusion. The physicians at New York-Presbyterian do not administer anticoagulation in these patients during the first 12 hours after shunt placement.
The median initial postoperative hematocrit was 41.7%, with a range of 31.7%-55.8%. The survival analysis the researchers performed found that for every 5 additional percentage points, the hazard ratio for early shunt occlusion was 2.7 (P = .007) and 1.74 for any shunt occlusion (P less than .001). Incidentally, four cases of early shunt occlusion occurred in the later study period after 2014, during which the average first postoperative hematocrit was significantly higher than in the pre-2014 study period, 45.3% vs. 41.5% (P = .21), and the odds of early shunt occlusion were 16 times higher (P less than .001). Dr. Anderson and coauthors said the possible explanation for this variation was a switch to a new point-of-care analyzer in 2013.
With regard to mortality, six infants overall (7.4%) died before discharge, and four (5%) within 30 days of shunt placement. No infants with early shunt occlusion died, although two with late shunt occlusion died. Increased inotrope score and first postoperative arterial oxygen tension were the only factors associated with increased mortality. “No significant association was identified between hematocrit and 30-day mortality,” Dr. Anderson and coauthors said.
In the first 24 hours after surgery, 11 infants (13.8%) received packed red blood cell (PRBC) transfusions, seven (8.8%) received platelets, and four (5%) received fresh frozen plasma/cryoprecipitate. Higher postoperative PRBC transfusion volumes were associated with increased odds of mortality (P = .001), but none of these factors were significantly associated with early shunt occlusion.
Dr. Anderson and coauthors acknowledged that shunt occlusion is a “vexing problem” in infants with cyanotic heart disease. While other researchers studied postoperative hematocrit levels and possible associations with outcomes, including shunt occlusion and mortality, the New York-Presbyterian investigators said this is the first study of the first postoperative hematocrit.
Dr. Anderson and coauthors said their findings raise the question about the ideal perioperative prophylactic antithrombotic therapy in these patients. These researchers initiate aspirin therapy 12 hours after surgery if hemostasis is established.
As a result of this study, Dr. Anderson and coauthors instituted a number of practice changes at their center. They include:
• Cardiac anesthesiologists have been asked not to transfuse shunted neonates with hematocrit level of greater than or equal to 35%, and hematocrits are then immediately repeated when a patient returns to the cardiac ICU.
• Patients with hematocrits greater than or equal to 55% get partial exchange transfusions.
• An individualized approach for patients with lower hematocrits who are more cyanotic than expected. This includes a diagnostic echocardiogram, nitric oxide, oxygen and heparin, escalated inotropic support if necessary and sometimes a cautious approach to transfusions if symptoms do not resolve and an acute shunt occlusion if not likely.
Dr. Anderson and coauthors acknowledged limits to their study, most notably its retrospective nature and a small population at a single center, and that large investigations are needed to validate their findings.
Dr. Anderson disclosed receiving salary support from the National Center for Advancing Translational Sciences. Coauthor Jennifer M. Duchon, MDCM, MPH, receives salary support from the National Institute of Allergy and Infectious Disease. The remaining coauthors had no financial relationships to disclose.
Shunt occlusion has been a well-documented cause of shunt failure in newborns who have had systemic to pulmonary shunt placement, and little has been known about why shunts occlude. However, researchers have reported in a small retrospective study that higher postoperative hematocrit levels immediately after surgery may be predictors of shunt occlusion.
Reporting in the April 2017 issue of The Journal of Thoracic and Cardiovascular Surgery, Brett R. Anderson, MD, of New York-Presbyterian/Morgan Stanley Children’s Hospital, Columbia University Medical Center in New York, and coauthors, found that every 5-point increase in postoperative hematocrit more than doubled an infant’s odds of having early shunt occlusion (J Thorac Cardiovasc Surg. 2017;153:947-55).
“Beginning in the latter half of 2014, we noticed an increase in the incidence of early shunt occlusions in our neonatal cardiac intensive care unit,” Dr. Anderson and coauthors said. So they conducted a retrospective chart review of 80 infants who had undergone systemic to pulmonary shunt placement from January 2010 to July 2015, hypothesizing that increased hematocrit in the early postoperative period might have caused early shunt occlusion. They investigated the association between the first postoperative hematocrit and early shunt occlusion and in-hospital mortality in these patients.
Five patients (6.3%) experienced early shunt occlusion – that is, within 24 hours of placement (actually, within 10 hours of placement). Overall, 12 infants (15%) experienced shunt occlusion. The physicians at New York-Presbyterian do not administer anticoagulation in these patients during the first 12 hours after shunt placement.
The median initial postoperative hematocrit was 41.7%, with a range of 31.7%-55.8%. The survival analysis the researchers performed found that for every 5 additional percentage points, the hazard ratio for early shunt occlusion was 2.7 (P = .007) and 1.74 for any shunt occlusion (P less than .001). Incidentally, four cases of early shunt occlusion occurred in the later study period after 2014, during which the average first postoperative hematocrit was significantly higher than in the pre-2014 study period, 45.3% vs. 41.5% (P = .21), and the odds of early shunt occlusion were 16 times higher (P less than .001). Dr. Anderson and coauthors said the possible explanation for this variation was a switch to a new point-of-care analyzer in 2013.
With regard to mortality, six infants overall (7.4%) died before discharge, and four (5%) within 30 days of shunt placement. No infants with early shunt occlusion died, although two with late shunt occlusion died. Increased inotrope score and first postoperative arterial oxygen tension were the only factors associated with increased mortality. “No significant association was identified between hematocrit and 30-day mortality,” Dr. Anderson and coauthors said.
In the first 24 hours after surgery, 11 infants (13.8%) received packed red blood cell (PRBC) transfusions, seven (8.8%) received platelets, and four (5%) received fresh frozen plasma/cryoprecipitate. Higher postoperative PRBC transfusion volumes were associated with increased odds of mortality (P = .001), but none of these factors were significantly associated with early shunt occlusion.
Dr. Anderson and coauthors acknowledged that shunt occlusion is a “vexing problem” in infants with cyanotic heart disease. While other researchers studied postoperative hematocrit levels and possible associations with outcomes, including shunt occlusion and mortality, the New York-Presbyterian investigators said this is the first study of the first postoperative hematocrit.
Dr. Anderson and coauthors said their findings raise the question about the ideal perioperative prophylactic antithrombotic therapy in these patients. These researchers initiate aspirin therapy 12 hours after surgery if hemostasis is established.
As a result of this study, Dr. Anderson and coauthors instituted a number of practice changes at their center. They include:
• Cardiac anesthesiologists have been asked not to transfuse shunted neonates with hematocrit level of greater than or equal to 35%, and hematocrits are then immediately repeated when a patient returns to the cardiac ICU.
• Patients with hematocrits greater than or equal to 55% get partial exchange transfusions.
• An individualized approach for patients with lower hematocrits who are more cyanotic than expected. This includes a diagnostic echocardiogram, nitric oxide, oxygen and heparin, escalated inotropic support if necessary and sometimes a cautious approach to transfusions if symptoms do not resolve and an acute shunt occlusion if not likely.
Dr. Anderson and coauthors acknowledged limits to their study, most notably its retrospective nature and a small population at a single center, and that large investigations are needed to validate their findings.
Dr. Anderson disclosed receiving salary support from the National Center for Advancing Translational Sciences. Coauthor Jennifer M. Duchon, MDCM, MPH, receives salary support from the National Institute of Allergy and Infectious Disease. The remaining coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Higher hematocrit levels have been associated with early shunt occlusion in newborns having systemic to pulmonary artery shunt placement.
Major finding: For every 5 additional percentage points of hematocrit, an infant’s odds of early shunt occlusion more than doubled (odds ratio, 2.70; P = .009).
Data source: Retrospective study of all newborns who underwent primary systemic to pulmonary artery shunt placement from January 2010 to July 2015 at a single center.
Disclosure: Dr. Anderson receives salary support from the National Center for Advancing Translational Sciences. Coauthor Jennifer M. Duchon, MDCM, MPH, receives salary support from the National Institute of Allergy and Infectious Disease. The remaining coauthors had no financial relationships to disclose.