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Snake in the grass
Most accomplished public speakers will tell you that critical to their success is the ability to understand and adapt to their audiences. It turns out that even chimpanzees accept and use this cornerstone of effective communication.
In a study published in Science Advances (2017 Nov 15;3[11]:e1701742), three scientists working in Uganda reported that chimpanzees who encounter a potential threat in the form of a realistic snake model will vocalize significantly fewer alert hoots if they hear other alert calls coming from the jungle in the vicinity. In other words, the chimp is saying to himself, “Why should I bother wasting my time and lung power hooting to warn my troop mates? Those guys already know about the snake.”
To select which anticipatory guidance topics to include and still be effective communicators, we have to know the families we are trying to help. Gaining this more nuanced picture of a family takes time and is fostered by continuity. Seeing a different provider at each visit doesn’t work very well here. What are this unique family’s concerns, regardless of what some committee thinks we should be asking?
How much can we rely on the media and groups such as the American Academy of Pediatrics and the Centers for Disease Control and Prevention to get out the messages that we have decided to skip over to address this family’s special concerns? Is the message about the benefits of breastfeeding so widely known that we will be wasting our limited office time repeating it? Is the same true for gun safety and seat belts? This is where research can help us decide where to target messages on a national level. But large population studies don’t always apply to our communities and the families we serve.
Where does our role as primary care physicians fit into the bigger picture of health education? The warning messages issued on a national level may have little relevance for our individual patients’ concerns. Is it our role to echo the message, or are we the ones who must do the fine-tuning?
And then there are the recent depressing and counterintuitive findings that for hot-button topics like immunization, education has little if any value. Those families with firmly held beliefs might acknowledge the rationale of our reasoning, but then quickly slide to another argument to tighten their grips on their original position.
Finally, we must be careful to avoid being labeled as the folks whose message is all about what parents should be afraid of. There are plenty of snakes out there in the jungle, but the chimpanzees have realized that when enough of the population is aware of the threat, then it is time to adjust their message. Certainly enough health problems exist on a national level to warrant continued messaging from the large groups in organized medicine. However, it is up to us out in the jungle to learn enough about our patients to know when we should echo those alerts and when it’s time to save our breath. We can’t hoot about every snake in the grass.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
Most accomplished public speakers will tell you that critical to their success is the ability to understand and adapt to their audiences. It turns out that even chimpanzees accept and use this cornerstone of effective communication.
In a study published in Science Advances (2017 Nov 15;3[11]:e1701742), three scientists working in Uganda reported that chimpanzees who encounter a potential threat in the form of a realistic snake model will vocalize significantly fewer alert hoots if they hear other alert calls coming from the jungle in the vicinity. In other words, the chimp is saying to himself, “Why should I bother wasting my time and lung power hooting to warn my troop mates? Those guys already know about the snake.”
To select which anticipatory guidance topics to include and still be effective communicators, we have to know the families we are trying to help. Gaining this more nuanced picture of a family takes time and is fostered by continuity. Seeing a different provider at each visit doesn’t work very well here. What are this unique family’s concerns, regardless of what some committee thinks we should be asking?
How much can we rely on the media and groups such as the American Academy of Pediatrics and the Centers for Disease Control and Prevention to get out the messages that we have decided to skip over to address this family’s special concerns? Is the message about the benefits of breastfeeding so widely known that we will be wasting our limited office time repeating it? Is the same true for gun safety and seat belts? This is where research can help us decide where to target messages on a national level. But large population studies don’t always apply to our communities and the families we serve.
Where does our role as primary care physicians fit into the bigger picture of health education? The warning messages issued on a national level may have little relevance for our individual patients’ concerns. Is it our role to echo the message, or are we the ones who must do the fine-tuning?
And then there are the recent depressing and counterintuitive findings that for hot-button topics like immunization, education has little if any value. Those families with firmly held beliefs might acknowledge the rationale of our reasoning, but then quickly slide to another argument to tighten their grips on their original position.
Finally, we must be careful to avoid being labeled as the folks whose message is all about what parents should be afraid of. There are plenty of snakes out there in the jungle, but the chimpanzees have realized that when enough of the population is aware of the threat, then it is time to adjust their message. Certainly enough health problems exist on a national level to warrant continued messaging from the large groups in organized medicine. However, it is up to us out in the jungle to learn enough about our patients to know when we should echo those alerts and when it’s time to save our breath. We can’t hoot about every snake in the grass.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
Most accomplished public speakers will tell you that critical to their success is the ability to understand and adapt to their audiences. It turns out that even chimpanzees accept and use this cornerstone of effective communication.
In a study published in Science Advances (2017 Nov 15;3[11]:e1701742), three scientists working in Uganda reported that chimpanzees who encounter a potential threat in the form of a realistic snake model will vocalize significantly fewer alert hoots if they hear other alert calls coming from the jungle in the vicinity. In other words, the chimp is saying to himself, “Why should I bother wasting my time and lung power hooting to warn my troop mates? Those guys already know about the snake.”
To select which anticipatory guidance topics to include and still be effective communicators, we have to know the families we are trying to help. Gaining this more nuanced picture of a family takes time and is fostered by continuity. Seeing a different provider at each visit doesn’t work very well here. What are this unique family’s concerns, regardless of what some committee thinks we should be asking?
How much can we rely on the media and groups such as the American Academy of Pediatrics and the Centers for Disease Control and Prevention to get out the messages that we have decided to skip over to address this family’s special concerns? Is the message about the benefits of breastfeeding so widely known that we will be wasting our limited office time repeating it? Is the same true for gun safety and seat belts? This is where research can help us decide where to target messages on a national level. But large population studies don’t always apply to our communities and the families we serve.
Where does our role as primary care physicians fit into the bigger picture of health education? The warning messages issued on a national level may have little relevance for our individual patients’ concerns. Is it our role to echo the message, or are we the ones who must do the fine-tuning?
And then there are the recent depressing and counterintuitive findings that for hot-button topics like immunization, education has little if any value. Those families with firmly held beliefs might acknowledge the rationale of our reasoning, but then quickly slide to another argument to tighten their grips on their original position.
Finally, we must be careful to avoid being labeled as the folks whose message is all about what parents should be afraid of. There are plenty of snakes out there in the jungle, but the chimpanzees have realized that when enough of the population is aware of the threat, then it is time to adjust their message. Certainly enough health problems exist on a national level to warrant continued messaging from the large groups in organized medicine. However, it is up to us out in the jungle to learn enough about our patients to know when we should echo those alerts and when it’s time to save our breath. We can’t hoot about every snake in the grass.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
Fenfluramine Reduces Convulsive Seizure Frequency in Dravet Syndrome
WASHINGTON, DC—Among patients with Dravet syndrome, adjunctive treatment with fenfluramine hydrochloride oral solution significantly reduces convulsive seizure frequency, compared with placebo, according to data presented at the 71st Annual Meeting of the American Epilepsy Society. The treatment is generally well tolerated at doses of 30 mg/day or less, and no clinical or echocardiographic signs of cardiac valvulopathy or pulmonary hypertension were observed in a phase III trial, investigators said.
Fenfluramine has been used at higher doses for weight loss, but the drug was withdrawn from US and European markets because it was associated with cardiac valvulopathy and pulmonary hypertension. Investigators in Belgium, however, continued exploratory studies of low-dose fenfluramine for refractory pediatric epilepsy. The studies suggested that fenfluramine reduced seizure frequency. Zogenix, based in Emeryville, California, is developing the drug, known as ZX008.
No FDA-approved treatments for seizures associated with Dravet syndrome exist, and 45% of patients with Dravet syndrome have four or more tonic-clonic seizures per month despite polytherapy with antiepileptic drugs (AEDs), said the investigators.
A Placebo-Controlled Trial
Lieven Lagae, MD, PhD, Professor at the University of Leuven in Belgium and Head of the Pediatric Neurology Department and Director of the Childhood Epilepsy Program at the University of Leuven Hospitals, and colleagues conducted a phase III, randomized, placebo-controlled, double-blind, 14-week, fixed-dose clinical trial at sites in the United States, Canada, Europe, and Australia.
The researchers included patients with Dravet syndrome ages 2 to 18 whose seizures were not completely controlled by their current AED regimen and whose medications and interventions (eg, ketogenic diet and vagal nerve stimulation) had been stable for at least four weeks before screening. The researchers excluded patients with a history of cardiovascular or cerebrovascular disease, concomitant serotonergic or cannabinoid treatment, treatment with stiripentol in the 21 days before screening, or any diagnosis that might alter the risk–benefit ratio or impede participation in the trial.
Patients underwent six weeks of baseline observation before they were randomized 1:1:1 to receive ZX008 (0.8 mg/kg/day), ZX008 (0.2 mg/kg/day), or placebo. The treatment period included a two-week titration period followed by a 12-week maintenance period. The maximum daily dose was 30 mg. The primary efficacy end point was change in mean convulsive seizure frequency from the baseline period to the 14-week treatment period between ZX008 (0.8 mg/kg/day) and placebo.
Frequency of Seizures
The study included 119 patients. Patients had a mean age of 9, and about 54% were male. Average baseline convulsive seizure frequency was about 42 seizures per 28 days.
Patients who received ZX008 (0.8 mg/kg/day) had a 63.9% reduction in mean monthly convulsive seizures, compared with placebo. The median percent reduction in monthly convulsive seizure frequency was 72.4% among patients who received ZX008 (0.8 mg/kg/day), compared with 17.4% among patients who received placebo.
Significantly more patients who received either dose of ZX008 had at least a 25%, 50%, or 75% reduction in convulsive seizures during treatment, compared with patients who received placebo. The median longest seizure-free interval was significantly longer in patients treated with ZX008 (0.8 mg/kg/day) or ZX008 (0.2 mg/kg/day), compared with patients who received placebo (20.5 days, 14 days, and nine days, respectively).
Noncardiovascular treatment-emergent adverse events included diarrhea, fatigue, lethargy, and decreased weight and appetite. “No cases of FDA-defined cardiac valvulopathy were observed during the trial,” the researchers said. “No echocardiographic findings or clinical symptoms suggesting pulmonary hypertension were noted.”
Caregivers and clinicians rated a greater proportion of patients who received ZX008 to be very much or much improved following treatment, compared with patients who received placebo. Results from another phase III trial are expected in 2018.
“Patients treated with ZX008 achieved a clinically meaningful reduction in seizure frequency,” said Dr. Lagae. “If approved, ZX008 could play an important role in changing the treatment paradigm for patients and their families whose lives have been greatly impacted by the lack of effective seizure control provided by current treatment options.”
WASHINGTON, DC—Among patients with Dravet syndrome, adjunctive treatment with fenfluramine hydrochloride oral solution significantly reduces convulsive seizure frequency, compared with placebo, according to data presented at the 71st Annual Meeting of the American Epilepsy Society. The treatment is generally well tolerated at doses of 30 mg/day or less, and no clinical or echocardiographic signs of cardiac valvulopathy or pulmonary hypertension were observed in a phase III trial, investigators said.
Fenfluramine has been used at higher doses for weight loss, but the drug was withdrawn from US and European markets because it was associated with cardiac valvulopathy and pulmonary hypertension. Investigators in Belgium, however, continued exploratory studies of low-dose fenfluramine for refractory pediatric epilepsy. The studies suggested that fenfluramine reduced seizure frequency. Zogenix, based in Emeryville, California, is developing the drug, known as ZX008.
No FDA-approved treatments for seizures associated with Dravet syndrome exist, and 45% of patients with Dravet syndrome have four or more tonic-clonic seizures per month despite polytherapy with antiepileptic drugs (AEDs), said the investigators.
A Placebo-Controlled Trial
Lieven Lagae, MD, PhD, Professor at the University of Leuven in Belgium and Head of the Pediatric Neurology Department and Director of the Childhood Epilepsy Program at the University of Leuven Hospitals, and colleagues conducted a phase III, randomized, placebo-controlled, double-blind, 14-week, fixed-dose clinical trial at sites in the United States, Canada, Europe, and Australia.
The researchers included patients with Dravet syndrome ages 2 to 18 whose seizures were not completely controlled by their current AED regimen and whose medications and interventions (eg, ketogenic diet and vagal nerve stimulation) had been stable for at least four weeks before screening. The researchers excluded patients with a history of cardiovascular or cerebrovascular disease, concomitant serotonergic or cannabinoid treatment, treatment with stiripentol in the 21 days before screening, or any diagnosis that might alter the risk–benefit ratio or impede participation in the trial.
Patients underwent six weeks of baseline observation before they were randomized 1:1:1 to receive ZX008 (0.8 mg/kg/day), ZX008 (0.2 mg/kg/day), or placebo. The treatment period included a two-week titration period followed by a 12-week maintenance period. The maximum daily dose was 30 mg. The primary efficacy end point was change in mean convulsive seizure frequency from the baseline period to the 14-week treatment period between ZX008 (0.8 mg/kg/day) and placebo.
Frequency of Seizures
The study included 119 patients. Patients had a mean age of 9, and about 54% were male. Average baseline convulsive seizure frequency was about 42 seizures per 28 days.
Patients who received ZX008 (0.8 mg/kg/day) had a 63.9% reduction in mean monthly convulsive seizures, compared with placebo. The median percent reduction in monthly convulsive seizure frequency was 72.4% among patients who received ZX008 (0.8 mg/kg/day), compared with 17.4% among patients who received placebo.
Significantly more patients who received either dose of ZX008 had at least a 25%, 50%, or 75% reduction in convulsive seizures during treatment, compared with patients who received placebo. The median longest seizure-free interval was significantly longer in patients treated with ZX008 (0.8 mg/kg/day) or ZX008 (0.2 mg/kg/day), compared with patients who received placebo (20.5 days, 14 days, and nine days, respectively).
Noncardiovascular treatment-emergent adverse events included diarrhea, fatigue, lethargy, and decreased weight and appetite. “No cases of FDA-defined cardiac valvulopathy were observed during the trial,” the researchers said. “No echocardiographic findings or clinical symptoms suggesting pulmonary hypertension were noted.”
Caregivers and clinicians rated a greater proportion of patients who received ZX008 to be very much or much improved following treatment, compared with patients who received placebo. Results from another phase III trial are expected in 2018.
“Patients treated with ZX008 achieved a clinically meaningful reduction in seizure frequency,” said Dr. Lagae. “If approved, ZX008 could play an important role in changing the treatment paradigm for patients and their families whose lives have been greatly impacted by the lack of effective seizure control provided by current treatment options.”
WASHINGTON, DC—Among patients with Dravet syndrome, adjunctive treatment with fenfluramine hydrochloride oral solution significantly reduces convulsive seizure frequency, compared with placebo, according to data presented at the 71st Annual Meeting of the American Epilepsy Society. The treatment is generally well tolerated at doses of 30 mg/day or less, and no clinical or echocardiographic signs of cardiac valvulopathy or pulmonary hypertension were observed in a phase III trial, investigators said.
Fenfluramine has been used at higher doses for weight loss, but the drug was withdrawn from US and European markets because it was associated with cardiac valvulopathy and pulmonary hypertension. Investigators in Belgium, however, continued exploratory studies of low-dose fenfluramine for refractory pediatric epilepsy. The studies suggested that fenfluramine reduced seizure frequency. Zogenix, based in Emeryville, California, is developing the drug, known as ZX008.
No FDA-approved treatments for seizures associated with Dravet syndrome exist, and 45% of patients with Dravet syndrome have four or more tonic-clonic seizures per month despite polytherapy with antiepileptic drugs (AEDs), said the investigators.
A Placebo-Controlled Trial
Lieven Lagae, MD, PhD, Professor at the University of Leuven in Belgium and Head of the Pediatric Neurology Department and Director of the Childhood Epilepsy Program at the University of Leuven Hospitals, and colleagues conducted a phase III, randomized, placebo-controlled, double-blind, 14-week, fixed-dose clinical trial at sites in the United States, Canada, Europe, and Australia.
The researchers included patients with Dravet syndrome ages 2 to 18 whose seizures were not completely controlled by their current AED regimen and whose medications and interventions (eg, ketogenic diet and vagal nerve stimulation) had been stable for at least four weeks before screening. The researchers excluded patients with a history of cardiovascular or cerebrovascular disease, concomitant serotonergic or cannabinoid treatment, treatment with stiripentol in the 21 days before screening, or any diagnosis that might alter the risk–benefit ratio or impede participation in the trial.
Patients underwent six weeks of baseline observation before they were randomized 1:1:1 to receive ZX008 (0.8 mg/kg/day), ZX008 (0.2 mg/kg/day), or placebo. The treatment period included a two-week titration period followed by a 12-week maintenance period. The maximum daily dose was 30 mg. The primary efficacy end point was change in mean convulsive seizure frequency from the baseline period to the 14-week treatment period between ZX008 (0.8 mg/kg/day) and placebo.
Frequency of Seizures
The study included 119 patients. Patients had a mean age of 9, and about 54% were male. Average baseline convulsive seizure frequency was about 42 seizures per 28 days.
Patients who received ZX008 (0.8 mg/kg/day) had a 63.9% reduction in mean monthly convulsive seizures, compared with placebo. The median percent reduction in monthly convulsive seizure frequency was 72.4% among patients who received ZX008 (0.8 mg/kg/day), compared with 17.4% among patients who received placebo.
Significantly more patients who received either dose of ZX008 had at least a 25%, 50%, or 75% reduction in convulsive seizures during treatment, compared with patients who received placebo. The median longest seizure-free interval was significantly longer in patients treated with ZX008 (0.8 mg/kg/day) or ZX008 (0.2 mg/kg/day), compared with patients who received placebo (20.5 days, 14 days, and nine days, respectively).
Noncardiovascular treatment-emergent adverse events included diarrhea, fatigue, lethargy, and decreased weight and appetite. “No cases of FDA-defined cardiac valvulopathy were observed during the trial,” the researchers said. “No echocardiographic findings or clinical symptoms suggesting pulmonary hypertension were noted.”
Caregivers and clinicians rated a greater proportion of patients who received ZX008 to be very much or much improved following treatment, compared with patients who received placebo. Results from another phase III trial are expected in 2018.
“Patients treated with ZX008 achieved a clinically meaningful reduction in seizure frequency,” said Dr. Lagae. “If approved, ZX008 could play an important role in changing the treatment paradigm for patients and their families whose lives have been greatly impacted by the lack of effective seizure control provided by current treatment options.”
AAP adds peramivir to influenza recommendations
The American Academy of Pediatrics Committee on Infectious Diseases has added information on peramivir, a recently approved antiviral medication, to its Recommendations for Prevention and Control of Influenza in Children for 2017-2018.
Peramivir (Rapivab) was approved by the Food and Drug Administration in September 2017, as an intravenous treatment for acute, uncomplicated influenza in nonhospitalized children aged 2 years and older who have been symptomatic for no more than 2 days, according to the update.
Peramivir is given to 2-12 year olds as a single infusion at 12 mg/kg, with a maximum dose of 600 mg, according to the guideline update (Pediatrics. 2017 Oct;140[4]:e20172550). Patients 13 years and older should receive the 600-mg dose.
“Rapivab is a great addition to our armamentarium of antiviral agents to combat influenza,” John A. Vanchiere, MD, PhD, chief of the section of pediatric infectious diseases at LSU Health Sciences Center, Shreveport. said in a press release from the drug’s manufacturer, BioCryst Pharmaceuticals. “It will be especially helpful for patients who cannot tolerate oral medications. In addition, the long half-life allows for one-time dosing, which will improve compliance.”
Dr. Vanchiere is the lead author in a study of peramivir’s effectiveness against pediatric influenza that was presented as a poster at ID Week 2017.
The phase 3, randomized, control trial included 122 patients, ranging in age from newborns to 18-year-olds, with acute uncomplicated influenza symptoms.
Investigators gave 92 patients peramivir, while the remaining 23 received oral oseltamivir (Tamiflu).
Nearly all (93%) of the patients were white; 61% had an influenza A strain infection, and there were comparable numbers of male and female study subjects.
Vomiting, fever, and tympanic membrane erythema were the most common adverse effects specifically reported in the study, which was funded by BioCryst.
Peramivir is the third neuraminidase inhibitor (NAI) to be approved; other approved NAIs include oral oseltamivir and inhaled zanamivir.
A fourth NAI, intravenous zanamivir, is still investigational in the United States.
Peramivir, like other antiviral drugs, may interfere with a live attenuated influenza vaccine and should not be used within 2 weeks after or 48 hours before the use of an LAIV.
While the AAP’s recommendations highlight the antiviral’s effectiveness in controlling influenza, the Academy warns that antivirals are not a substitute for influenza vaccination.
ezimmerman@frontlinemedcom.com
The American Academy of Pediatrics Committee on Infectious Diseases has added information on peramivir, a recently approved antiviral medication, to its Recommendations for Prevention and Control of Influenza in Children for 2017-2018.
Peramivir (Rapivab) was approved by the Food and Drug Administration in September 2017, as an intravenous treatment for acute, uncomplicated influenza in nonhospitalized children aged 2 years and older who have been symptomatic for no more than 2 days, according to the update.
Peramivir is given to 2-12 year olds as a single infusion at 12 mg/kg, with a maximum dose of 600 mg, according to the guideline update (Pediatrics. 2017 Oct;140[4]:e20172550). Patients 13 years and older should receive the 600-mg dose.
“Rapivab is a great addition to our armamentarium of antiviral agents to combat influenza,” John A. Vanchiere, MD, PhD, chief of the section of pediatric infectious diseases at LSU Health Sciences Center, Shreveport. said in a press release from the drug’s manufacturer, BioCryst Pharmaceuticals. “It will be especially helpful for patients who cannot tolerate oral medications. In addition, the long half-life allows for one-time dosing, which will improve compliance.”
Dr. Vanchiere is the lead author in a study of peramivir’s effectiveness against pediatric influenza that was presented as a poster at ID Week 2017.
The phase 3, randomized, control trial included 122 patients, ranging in age from newborns to 18-year-olds, with acute uncomplicated influenza symptoms.
Investigators gave 92 patients peramivir, while the remaining 23 received oral oseltamivir (Tamiflu).
Nearly all (93%) of the patients were white; 61% had an influenza A strain infection, and there were comparable numbers of male and female study subjects.
Vomiting, fever, and tympanic membrane erythema were the most common adverse effects specifically reported in the study, which was funded by BioCryst.
Peramivir is the third neuraminidase inhibitor (NAI) to be approved; other approved NAIs include oral oseltamivir and inhaled zanamivir.
A fourth NAI, intravenous zanamivir, is still investigational in the United States.
Peramivir, like other antiviral drugs, may interfere with a live attenuated influenza vaccine and should not be used within 2 weeks after or 48 hours before the use of an LAIV.
While the AAP’s recommendations highlight the antiviral’s effectiveness in controlling influenza, the Academy warns that antivirals are not a substitute for influenza vaccination.
ezimmerman@frontlinemedcom.com
The American Academy of Pediatrics Committee on Infectious Diseases has added information on peramivir, a recently approved antiviral medication, to its Recommendations for Prevention and Control of Influenza in Children for 2017-2018.
Peramivir (Rapivab) was approved by the Food and Drug Administration in September 2017, as an intravenous treatment for acute, uncomplicated influenza in nonhospitalized children aged 2 years and older who have been symptomatic for no more than 2 days, according to the update.
Peramivir is given to 2-12 year olds as a single infusion at 12 mg/kg, with a maximum dose of 600 mg, according to the guideline update (Pediatrics. 2017 Oct;140[4]:e20172550). Patients 13 years and older should receive the 600-mg dose.
“Rapivab is a great addition to our armamentarium of antiviral agents to combat influenza,” John A. Vanchiere, MD, PhD, chief of the section of pediatric infectious diseases at LSU Health Sciences Center, Shreveport. said in a press release from the drug’s manufacturer, BioCryst Pharmaceuticals. “It will be especially helpful for patients who cannot tolerate oral medications. In addition, the long half-life allows for one-time dosing, which will improve compliance.”
Dr. Vanchiere is the lead author in a study of peramivir’s effectiveness against pediatric influenza that was presented as a poster at ID Week 2017.
The phase 3, randomized, control trial included 122 patients, ranging in age from newborns to 18-year-olds, with acute uncomplicated influenza symptoms.
Investigators gave 92 patients peramivir, while the remaining 23 received oral oseltamivir (Tamiflu).
Nearly all (93%) of the patients were white; 61% had an influenza A strain infection, and there were comparable numbers of male and female study subjects.
Vomiting, fever, and tympanic membrane erythema were the most common adverse effects specifically reported in the study, which was funded by BioCryst.
Peramivir is the third neuraminidase inhibitor (NAI) to be approved; other approved NAIs include oral oseltamivir and inhaled zanamivir.
A fourth NAI, intravenous zanamivir, is still investigational in the United States.
Peramivir, like other antiviral drugs, may interfere with a live attenuated influenza vaccine and should not be used within 2 weeks after or 48 hours before the use of an LAIV.
While the AAP’s recommendations highlight the antiviral’s effectiveness in controlling influenza, the Academy warns that antivirals are not a substitute for influenza vaccination.
ezimmerman@frontlinemedcom.com
Study: Atopic dermatitis subgroups identified in children
Identification of subphenotypes of atopic dermatitis (AD) in children, with differing risk factors, prognoses, and comorbidities, could lead to a stratified approach to managing pediatric AD, said Lavinia Paternoster, PhD, of the University of Bristol, England, and her associates.
The study identified six classes of AD in these children. Early-onset/early-resolving AD, occurring in 13%-15% of the children, was most prevalent and was associated with male gender. Children in this class had a favorable prognosis, and there was only a very weak association with asthma in later life.
Two classes of persistent disease were identified: early-onset persistent AD (rash occurring in most of this class by 30 months and resolving in half by 16.5 years) and early-onset/late-resolving AD (rash occurring in most by 30 months and resolving in most by 16.5 years). These classes, occurring in about 7% of the children, had the strongest association with an AD genetic risk score; a strong link with personal and parental history of atopic disease; and a strong tie to asthma.
An unrecognized class of mid-onset-resolving AD, occurring in 7% of children, was not significantly linked to FLG mutations but was tied to asthma. In those children, AD prevalence rose sharply from 2.5 years of age and peaked at about 6 years, Dr. Paternoster and her associates said.
The investigators also found an unaffected/transient AD class in which children either had never reported rash; had one or two isolated occasions of rash; or reported a rash consistent with AD at 6-18 months that declined with age. In the two cohorts, 58%-63% children fell into this class. Late-onset-resolving AD occurred in 7%-8% of children, with most developing rash by 12 years and declining by 16.5 years.
There was a preponderance of females in the early-onset persistent AD and the late onset classes, and more males in the early-onset resolving class. “The associations with asthma at ages 7 and 11-13 years were strongest with the persistent class, but all AD classes showed evidence of some increased risk of asthma at these ages,” Dr. Paternoster and her associates wrote.
“There was evidence that FLG null mutations were associated with all classes, however ... the association was strongest in the group with early-onset-persistent disease,” the researchers said. The “heterogeneity of effect of genetic variants on different disease profiles, emphasizes the need for patient stratification in future genetic studies. Stratification may be used to increase the power to detect variants associated with specific classes; stratification could also allow the identification of phenotype-specific mechanistic pathways as future therapeutic targets.”
Read more at (J Allerg Clin Immunol. 2017 Nov 10. doi: 10.1016/j.jaci.2017.09.044).
Identification of subphenotypes of atopic dermatitis (AD) in children, with differing risk factors, prognoses, and comorbidities, could lead to a stratified approach to managing pediatric AD, said Lavinia Paternoster, PhD, of the University of Bristol, England, and her associates.
The study identified six classes of AD in these children. Early-onset/early-resolving AD, occurring in 13%-15% of the children, was most prevalent and was associated with male gender. Children in this class had a favorable prognosis, and there was only a very weak association with asthma in later life.
Two classes of persistent disease were identified: early-onset persistent AD (rash occurring in most of this class by 30 months and resolving in half by 16.5 years) and early-onset/late-resolving AD (rash occurring in most by 30 months and resolving in most by 16.5 years). These classes, occurring in about 7% of the children, had the strongest association with an AD genetic risk score; a strong link with personal and parental history of atopic disease; and a strong tie to asthma.
An unrecognized class of mid-onset-resolving AD, occurring in 7% of children, was not significantly linked to FLG mutations but was tied to asthma. In those children, AD prevalence rose sharply from 2.5 years of age and peaked at about 6 years, Dr. Paternoster and her associates said.
The investigators also found an unaffected/transient AD class in which children either had never reported rash; had one or two isolated occasions of rash; or reported a rash consistent with AD at 6-18 months that declined with age. In the two cohorts, 58%-63% children fell into this class. Late-onset-resolving AD occurred in 7%-8% of children, with most developing rash by 12 years and declining by 16.5 years.
There was a preponderance of females in the early-onset persistent AD and the late onset classes, and more males in the early-onset resolving class. “The associations with asthma at ages 7 and 11-13 years were strongest with the persistent class, but all AD classes showed evidence of some increased risk of asthma at these ages,” Dr. Paternoster and her associates wrote.
“There was evidence that FLG null mutations were associated with all classes, however ... the association was strongest in the group with early-onset-persistent disease,” the researchers said. The “heterogeneity of effect of genetic variants on different disease profiles, emphasizes the need for patient stratification in future genetic studies. Stratification may be used to increase the power to detect variants associated with specific classes; stratification could also allow the identification of phenotype-specific mechanistic pathways as future therapeutic targets.”
Read more at (J Allerg Clin Immunol. 2017 Nov 10. doi: 10.1016/j.jaci.2017.09.044).
Identification of subphenotypes of atopic dermatitis (AD) in children, with differing risk factors, prognoses, and comorbidities, could lead to a stratified approach to managing pediatric AD, said Lavinia Paternoster, PhD, of the University of Bristol, England, and her associates.
The study identified six classes of AD in these children. Early-onset/early-resolving AD, occurring in 13%-15% of the children, was most prevalent and was associated with male gender. Children in this class had a favorable prognosis, and there was only a very weak association with asthma in later life.
Two classes of persistent disease were identified: early-onset persistent AD (rash occurring in most of this class by 30 months and resolving in half by 16.5 years) and early-onset/late-resolving AD (rash occurring in most by 30 months and resolving in most by 16.5 years). These classes, occurring in about 7% of the children, had the strongest association with an AD genetic risk score; a strong link with personal and parental history of atopic disease; and a strong tie to asthma.
An unrecognized class of mid-onset-resolving AD, occurring in 7% of children, was not significantly linked to FLG mutations but was tied to asthma. In those children, AD prevalence rose sharply from 2.5 years of age and peaked at about 6 years, Dr. Paternoster and her associates said.
The investigators also found an unaffected/transient AD class in which children either had never reported rash; had one or two isolated occasions of rash; or reported a rash consistent with AD at 6-18 months that declined with age. In the two cohorts, 58%-63% children fell into this class. Late-onset-resolving AD occurred in 7%-8% of children, with most developing rash by 12 years and declining by 16.5 years.
There was a preponderance of females in the early-onset persistent AD and the late onset classes, and more males in the early-onset resolving class. “The associations with asthma at ages 7 and 11-13 years were strongest with the persistent class, but all AD classes showed evidence of some increased risk of asthma at these ages,” Dr. Paternoster and her associates wrote.
“There was evidence that FLG null mutations were associated with all classes, however ... the association was strongest in the group with early-onset-persistent disease,” the researchers said. The “heterogeneity of effect of genetic variants on different disease profiles, emphasizes the need for patient stratification in future genetic studies. Stratification may be used to increase the power to detect variants associated with specific classes; stratification could also allow the identification of phenotype-specific mechanistic pathways as future therapeutic targets.”
Read more at (J Allerg Clin Immunol. 2017 Nov 10. doi: 10.1016/j.jaci.2017.09.044).
FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Contraceptive use appears low in teen girls on teratogenic medications
SAN DIEGO – A majority of U.S. teenage girls on Medicaid who were prescribed teratogenic medications for rheumatic diseases did not receive or fill prescriptions for contraception, and some became pregnant while taking the medication, a study showed.
The analysis of a Medicaid database of paid claims from 12 unidentified U.S. states during 2013-2015 found a pregnancy rate of 7.6% in 4,853 females aged 15-19 who were prescribed at least one of eight teratogenic medications, mostly labeled as category D or X: cyclophosphamide, enalapril, leflunomide, lisinopril, losartan, methotrexate, mycophenolate, and cyclosporine (category C). This rate varied from 2.2% in 15-year-olds to 13.6% in 19-year-olds.
The number of filled prescriptions for contraception was low despite the associated risk of the teratogenic medications, said Dr. Hays, a third-year pediatric rheumatology fellow at the Medical University of South Carolina in Charleston.
“Each teratogenic medication carries a different risk,” she said. “Certain teratogenic medications carry a greater risk than other teratogenic medications. The associated risk may vary based on the timing and duration of use.”
“The risks and benefits of using a teratogenic medication for treatment should be discussed with teens and women of reproductive age,” Dr. Hays said. “Disease activity should be low, and the teratogenic medication should be replaced with a safer medication prior to pregnancy if one is available. Highly effective forms of contraception should be offered to patients who are at risk for unintended pregnancy and those who are not trying to conceive.”
In addition to rheumatic diseases, the eight teratogenic medications cited in the study are used to treat other conditions such as inflammatory bowel disease, hypertension, kidney disease, and malignancy, Dr. Hays said.
The study population was made up of 45.0% whites, 36.6% blacks, 4.8% Hispanics, and 13.6% others.
About 10% were defined as having a specific rheumatic disease, mainly systemic lupus erythematosus (70%), Dr. Hays said. “However, more than 10% had a rheumatic condition of some kind. Generalizations in ICD-9 coding made it difficult to identify specific diseases in some cases.”
The study did not examine birth defect outcomes in the babies born to the females in the cohort, but Dr. Hays said researchers are considering whether to track these numbers via claims data. The study also was not able to capture the use of nonprescribed contraception, such as condoms.
Moving forward, Dr. Hays said the researchers “are planning to also look at pregnancy and contraception rates in age-matched teens not taking teratogenic medications using the same Medicaid claims database. We are also hoping to research patient and provider perspectives pertaining to teratogenic medication use/risk and contraception.”
In addition, researchers hope to examine how commonly the individual drugs were prescribed and link them to contraception use and pregnancy, she said.
The study authors had no relevant financial disclosures, and the study had no external funding. The Medical University of South Carolina provided funding for database access.
SOURCE: Hays K et al. ACR 2017 Abstract 1813.
SAN DIEGO – A majority of U.S. teenage girls on Medicaid who were prescribed teratogenic medications for rheumatic diseases did not receive or fill prescriptions for contraception, and some became pregnant while taking the medication, a study showed.
The analysis of a Medicaid database of paid claims from 12 unidentified U.S. states during 2013-2015 found a pregnancy rate of 7.6% in 4,853 females aged 15-19 who were prescribed at least one of eight teratogenic medications, mostly labeled as category D or X: cyclophosphamide, enalapril, leflunomide, lisinopril, losartan, methotrexate, mycophenolate, and cyclosporine (category C). This rate varied from 2.2% in 15-year-olds to 13.6% in 19-year-olds.
The number of filled prescriptions for contraception was low despite the associated risk of the teratogenic medications, said Dr. Hays, a third-year pediatric rheumatology fellow at the Medical University of South Carolina in Charleston.
“Each teratogenic medication carries a different risk,” she said. “Certain teratogenic medications carry a greater risk than other teratogenic medications. The associated risk may vary based on the timing and duration of use.”
“The risks and benefits of using a teratogenic medication for treatment should be discussed with teens and women of reproductive age,” Dr. Hays said. “Disease activity should be low, and the teratogenic medication should be replaced with a safer medication prior to pregnancy if one is available. Highly effective forms of contraception should be offered to patients who are at risk for unintended pregnancy and those who are not trying to conceive.”
In addition to rheumatic diseases, the eight teratogenic medications cited in the study are used to treat other conditions such as inflammatory bowel disease, hypertension, kidney disease, and malignancy, Dr. Hays said.
The study population was made up of 45.0% whites, 36.6% blacks, 4.8% Hispanics, and 13.6% others.
About 10% were defined as having a specific rheumatic disease, mainly systemic lupus erythematosus (70%), Dr. Hays said. “However, more than 10% had a rheumatic condition of some kind. Generalizations in ICD-9 coding made it difficult to identify specific diseases in some cases.”
The study did not examine birth defect outcomes in the babies born to the females in the cohort, but Dr. Hays said researchers are considering whether to track these numbers via claims data. The study also was not able to capture the use of nonprescribed contraception, such as condoms.
Moving forward, Dr. Hays said the researchers “are planning to also look at pregnancy and contraception rates in age-matched teens not taking teratogenic medications using the same Medicaid claims database. We are also hoping to research patient and provider perspectives pertaining to teratogenic medication use/risk and contraception.”
In addition, researchers hope to examine how commonly the individual drugs were prescribed and link them to contraception use and pregnancy, she said.
The study authors had no relevant financial disclosures, and the study had no external funding. The Medical University of South Carolina provided funding for database access.
SOURCE: Hays K et al. ACR 2017 Abstract 1813.
SAN DIEGO – A majority of U.S. teenage girls on Medicaid who were prescribed teratogenic medications for rheumatic diseases did not receive or fill prescriptions for contraception, and some became pregnant while taking the medication, a study showed.
The analysis of a Medicaid database of paid claims from 12 unidentified U.S. states during 2013-2015 found a pregnancy rate of 7.6% in 4,853 females aged 15-19 who were prescribed at least one of eight teratogenic medications, mostly labeled as category D or X: cyclophosphamide, enalapril, leflunomide, lisinopril, losartan, methotrexate, mycophenolate, and cyclosporine (category C). This rate varied from 2.2% in 15-year-olds to 13.6% in 19-year-olds.
The number of filled prescriptions for contraception was low despite the associated risk of the teratogenic medications, said Dr. Hays, a third-year pediatric rheumatology fellow at the Medical University of South Carolina in Charleston.
“Each teratogenic medication carries a different risk,” she said. “Certain teratogenic medications carry a greater risk than other teratogenic medications. The associated risk may vary based on the timing and duration of use.”
“The risks and benefits of using a teratogenic medication for treatment should be discussed with teens and women of reproductive age,” Dr. Hays said. “Disease activity should be low, and the teratogenic medication should be replaced with a safer medication prior to pregnancy if one is available. Highly effective forms of contraception should be offered to patients who are at risk for unintended pregnancy and those who are not trying to conceive.”
In addition to rheumatic diseases, the eight teratogenic medications cited in the study are used to treat other conditions such as inflammatory bowel disease, hypertension, kidney disease, and malignancy, Dr. Hays said.
The study population was made up of 45.0% whites, 36.6% blacks, 4.8% Hispanics, and 13.6% others.
About 10% were defined as having a specific rheumatic disease, mainly systemic lupus erythematosus (70%), Dr. Hays said. “However, more than 10% had a rheumatic condition of some kind. Generalizations in ICD-9 coding made it difficult to identify specific diseases in some cases.”
The study did not examine birth defect outcomes in the babies born to the females in the cohort, but Dr. Hays said researchers are considering whether to track these numbers via claims data. The study also was not able to capture the use of nonprescribed contraception, such as condoms.
Moving forward, Dr. Hays said the researchers “are planning to also look at pregnancy and contraception rates in age-matched teens not taking teratogenic medications using the same Medicaid claims database. We are also hoping to research patient and provider perspectives pertaining to teratogenic medication use/risk and contraception.”
In addition, researchers hope to examine how commonly the individual drugs were prescribed and link them to contraception use and pregnancy, she said.
The study authors had no relevant financial disclosures, and the study had no external funding. The Medical University of South Carolina provided funding for database access.
SOURCE: Hays K et al. ACR 2017 Abstract 1813.
REPORTING FROM ACR 2017
Key clinical point:
Major finding: A total of 7.6% of teen girls taking teratogenic medications became pregnant during a 3-year period.
Study details: An analysis of 4,853 females aged 15-19 on Medicaid who were taking teratogenic medications.
Disclosures: The study authors had no relevant financial disclosures. The study had no external funding. The Medical University of South Carolina provided funding for database access.
Source: Hays K et al. ACR 2017 Abstract 1813.
Identity crisis
The provider has received “advanced-level education in pharmacology, pathophysiology, and physical assessment, diagnosis, and management” and provides patient care in a medical home “in a holistic fashion including physical care, therapeutic treatments, education, and coordination of services.”
This quote comes from a recent story in Pediatric News about collaborative practice. Was the author offering a job description of a) a chiropractor, b) a nurse practitioner, c) a pediatric oncologist, or d) a primary care physician?
Based on my personal experience working with nurse practitioners, both in hospital and office settings, I wholeheartedly concur with Dr. Haut’s list of their qualifications and capabilities. My problem is that she doesn’t list, nor can I comfortably imagine, the additional skills that a physician should have in his or her toolbox to complete the complementary relationships in a primary care practice that Dr. Haut envisions.
From my perspective, nurse practitioners and primary care physicians share the same job description, the one I listed in the first paragraph of this column. They both provide face-to-face, usually hands-on, medical care. At that critical interface between patient and provider, how do their roles differ? What other skills does a physician need to complement those of a competent and already experienced nurse practitioner?
Does being a physician guarantee that he or she has more experience than a nurse practitioner? You know as well as I do that you finished your training pretty wet behind the ears, and the first 5 years or more of your practice career were when you really began to feel like a competent provider. If my child has an earache, I would probably be more comfortable, or at least as comfortable, with her seeing a nurse practitioner with 5 years of experience in a busy practice than a newly minted, board-eligible pediatrician.
Is the breadth of a physician’s training in medical school an asset? Does the 2-month rotation he or she did on the adult neurology service taking care of stroke victims give the physician an advantage when it comes to taking care of pediatric patients with asthma?
Actually, I can imagine a suite of skills that a physician might bring to a collaborative practice that a nurse practitioner may not have, or more likely may have chosen not to pursue. Those skills have little to do with direct patient care, but can be critical for survival in today’s medical care environment. Here I am thinking of things such as negotiating with third-party payers, and leading and/or administering the complexities of a medium-sized or larger medical group. Does having a degree from a medical school automatically mean that the graduate is a skilled leader or administrator?
I can envision that over time a physician and a nurse practitioner might create an arrangement in which one of them focuses on the patients with asthma and attention-deficit/hyperactivity disorder, and the other develops an expertise in breastfeeding management and picky eating. That kind of relationship fits my definition of complementary. However, a relationship in which the doctor is the boss and the nurse practitioner is not doesn’t feel complementary or collaborative to me.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
The provider has received “advanced-level education in pharmacology, pathophysiology, and physical assessment, diagnosis, and management” and provides patient care in a medical home “in a holistic fashion including physical care, therapeutic treatments, education, and coordination of services.”
This quote comes from a recent story in Pediatric News about collaborative practice. Was the author offering a job description of a) a chiropractor, b) a nurse practitioner, c) a pediatric oncologist, or d) a primary care physician?
Based on my personal experience working with nurse practitioners, both in hospital and office settings, I wholeheartedly concur with Dr. Haut’s list of their qualifications and capabilities. My problem is that she doesn’t list, nor can I comfortably imagine, the additional skills that a physician should have in his or her toolbox to complete the complementary relationships in a primary care practice that Dr. Haut envisions.
From my perspective, nurse practitioners and primary care physicians share the same job description, the one I listed in the first paragraph of this column. They both provide face-to-face, usually hands-on, medical care. At that critical interface between patient and provider, how do their roles differ? What other skills does a physician need to complement those of a competent and already experienced nurse practitioner?
Does being a physician guarantee that he or she has more experience than a nurse practitioner? You know as well as I do that you finished your training pretty wet behind the ears, and the first 5 years or more of your practice career were when you really began to feel like a competent provider. If my child has an earache, I would probably be more comfortable, or at least as comfortable, with her seeing a nurse practitioner with 5 years of experience in a busy practice than a newly minted, board-eligible pediatrician.
Is the breadth of a physician’s training in medical school an asset? Does the 2-month rotation he or she did on the adult neurology service taking care of stroke victims give the physician an advantage when it comes to taking care of pediatric patients with asthma?
Actually, I can imagine a suite of skills that a physician might bring to a collaborative practice that a nurse practitioner may not have, or more likely may have chosen not to pursue. Those skills have little to do with direct patient care, but can be critical for survival in today’s medical care environment. Here I am thinking of things such as negotiating with third-party payers, and leading and/or administering the complexities of a medium-sized or larger medical group. Does having a degree from a medical school automatically mean that the graduate is a skilled leader or administrator?
I can envision that over time a physician and a nurse practitioner might create an arrangement in which one of them focuses on the patients with asthma and attention-deficit/hyperactivity disorder, and the other develops an expertise in breastfeeding management and picky eating. That kind of relationship fits my definition of complementary. However, a relationship in which the doctor is the boss and the nurse practitioner is not doesn’t feel complementary or collaborative to me.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
The provider has received “advanced-level education in pharmacology, pathophysiology, and physical assessment, diagnosis, and management” and provides patient care in a medical home “in a holistic fashion including physical care, therapeutic treatments, education, and coordination of services.”
This quote comes from a recent story in Pediatric News about collaborative practice. Was the author offering a job description of a) a chiropractor, b) a nurse practitioner, c) a pediatric oncologist, or d) a primary care physician?
Based on my personal experience working with nurse practitioners, both in hospital and office settings, I wholeheartedly concur with Dr. Haut’s list of their qualifications and capabilities. My problem is that she doesn’t list, nor can I comfortably imagine, the additional skills that a physician should have in his or her toolbox to complete the complementary relationships in a primary care practice that Dr. Haut envisions.
From my perspective, nurse practitioners and primary care physicians share the same job description, the one I listed in the first paragraph of this column. They both provide face-to-face, usually hands-on, medical care. At that critical interface between patient and provider, how do their roles differ? What other skills does a physician need to complement those of a competent and already experienced nurse practitioner?
Does being a physician guarantee that he or she has more experience than a nurse practitioner? You know as well as I do that you finished your training pretty wet behind the ears, and the first 5 years or more of your practice career were when you really began to feel like a competent provider. If my child has an earache, I would probably be more comfortable, or at least as comfortable, with her seeing a nurse practitioner with 5 years of experience in a busy practice than a newly minted, board-eligible pediatrician.
Is the breadth of a physician’s training in medical school an asset? Does the 2-month rotation he or she did on the adult neurology service taking care of stroke victims give the physician an advantage when it comes to taking care of pediatric patients with asthma?
Actually, I can imagine a suite of skills that a physician might bring to a collaborative practice that a nurse practitioner may not have, or more likely may have chosen not to pursue. Those skills have little to do with direct patient care, but can be critical for survival in today’s medical care environment. Here I am thinking of things such as negotiating with third-party payers, and leading and/or administering the complexities of a medium-sized or larger medical group. Does having a degree from a medical school automatically mean that the graduate is a skilled leader or administrator?
I can envision that over time a physician and a nurse practitioner might create an arrangement in which one of them focuses on the patients with asthma and attention-deficit/hyperactivity disorder, and the other develops an expertise in breastfeeding management and picky eating. That kind of relationship fits my definition of complementary. However, a relationship in which the doctor is the boss and the nurse practitioner is not doesn’t feel complementary or collaborative to me.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
FDA axes asthma drugs’ boxed warning
The Food and Drug Administration has eliminated the boxed warning for risk of asthma-related death from the labels of products containing both an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), the agency announced.
In 2011, the FDA required companies manufacturing fixed-dose LABA-ICS combination products to conduct 26-week clinical safety trials to evaluate the risks of serious adverse asthma-related events in patients treated with these drugs. Specifically, the companies had to compare the risks of taking a LABA in combination with an ICS with the risks of taking an ICS alone.
The removal of the boxed warning follows the FDA’s review of these trials, which found that treating asthma with LABAs in combination with ICS did not result in patients experiencing significantly more serious asthma-related side effects and asthma-related deaths, compared with those being treated with an ICS alone, according to the FDA announcement. “Results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results,” the statement added.
“These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone,” the FDA said in the statement.
The trials also demonstrated that using the combination reduced asthma exacerbations, compared with using ICS alone, and that most of the exacerbations “were those that required at least 3 days of systemic corticosteroids” – information that is being added the product labels, according to the FDA.
The products that will no longer carry this boxed warning in their labels include AstraZeneca’s budesonide/formoterol fumarate dihydrate (Symbicort) and GlaxoSmithKline’s fluticasone furoate/vilanterol (Breo Ellipta) and fluticasone propionate/salmeterol (Advair Diskus and Advair HFA).
The FDA also approved updates to the Warnings and Precautions section of labeling for the ICS/LABA class, which now includes a description of the four trials. Information on the efficacy of the drugs, found in the trials, has been added to the Clinical Studies section of the labels as well.
In a related safety announcement, the FDA stated the following: “Using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labels of all single-ingredient LABA medicines, which are approved to treat asthma, chronic obstructive pulmonary disease (COPD), and wheezing caused by exercise. The labels of medicines that contain both an ICS and LABA also retain a Warning and Precaution related to the increased risk of asthma-related death when LABAs are used without an ICS to treat asthma.
The Food and Drug Administration has eliminated the boxed warning for risk of asthma-related death from the labels of products containing both an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), the agency announced.
In 2011, the FDA required companies manufacturing fixed-dose LABA-ICS combination products to conduct 26-week clinical safety trials to evaluate the risks of serious adverse asthma-related events in patients treated with these drugs. Specifically, the companies had to compare the risks of taking a LABA in combination with an ICS with the risks of taking an ICS alone.
The removal of the boxed warning follows the FDA’s review of these trials, which found that treating asthma with LABAs in combination with ICS did not result in patients experiencing significantly more serious asthma-related side effects and asthma-related deaths, compared with those being treated with an ICS alone, according to the FDA announcement. “Results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results,” the statement added.
“These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone,” the FDA said in the statement.
The trials also demonstrated that using the combination reduced asthma exacerbations, compared with using ICS alone, and that most of the exacerbations “were those that required at least 3 days of systemic corticosteroids” – information that is being added the product labels, according to the FDA.
The products that will no longer carry this boxed warning in their labels include AstraZeneca’s budesonide/formoterol fumarate dihydrate (Symbicort) and GlaxoSmithKline’s fluticasone furoate/vilanterol (Breo Ellipta) and fluticasone propionate/salmeterol (Advair Diskus and Advair HFA).
The FDA also approved updates to the Warnings and Precautions section of labeling for the ICS/LABA class, which now includes a description of the four trials. Information on the efficacy of the drugs, found in the trials, has been added to the Clinical Studies section of the labels as well.
In a related safety announcement, the FDA stated the following: “Using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labels of all single-ingredient LABA medicines, which are approved to treat asthma, chronic obstructive pulmonary disease (COPD), and wheezing caused by exercise. The labels of medicines that contain both an ICS and LABA also retain a Warning and Precaution related to the increased risk of asthma-related death when LABAs are used without an ICS to treat asthma.
The Food and Drug Administration has eliminated the boxed warning for risk of asthma-related death from the labels of products containing both an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), the agency announced.
In 2011, the FDA required companies manufacturing fixed-dose LABA-ICS combination products to conduct 26-week clinical safety trials to evaluate the risks of serious adverse asthma-related events in patients treated with these drugs. Specifically, the companies had to compare the risks of taking a LABA in combination with an ICS with the risks of taking an ICS alone.
The removal of the boxed warning follows the FDA’s review of these trials, which found that treating asthma with LABAs in combination with ICS did not result in patients experiencing significantly more serious asthma-related side effects and asthma-related deaths, compared with those being treated with an ICS alone, according to the FDA announcement. “Results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results,” the statement added.
“These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone,” the FDA said in the statement.
The trials also demonstrated that using the combination reduced asthma exacerbations, compared with using ICS alone, and that most of the exacerbations “were those that required at least 3 days of systemic corticosteroids” – information that is being added the product labels, according to the FDA.
The products that will no longer carry this boxed warning in their labels include AstraZeneca’s budesonide/formoterol fumarate dihydrate (Symbicort) and GlaxoSmithKline’s fluticasone furoate/vilanterol (Breo Ellipta) and fluticasone propionate/salmeterol (Advair Diskus and Advair HFA).
The FDA also approved updates to the Warnings and Precautions section of labeling for the ICS/LABA class, which now includes a description of the four trials. Information on the efficacy of the drugs, found in the trials, has been added to the Clinical Studies section of the labels as well.
In a related safety announcement, the FDA stated the following: “Using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labels of all single-ingredient LABA medicines, which are approved to treat asthma, chronic obstructive pulmonary disease (COPD), and wheezing caused by exercise. The labels of medicines that contain both an ICS and LABA also retain a Warning and Precaution related to the increased risk of asthma-related death when LABAs are used without an ICS to treat asthma.
Update on Otitis
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Drug approved for kids with sickle cell anemia
The US Food and Drug Administration (FDA) has approved a hydroxyurea product (Addmedica’s Siklos) for use in pediatric patients with sickle cell anemia.
Siklos is intended to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients age 2 and older who have sickle cell anemia and recurrent moderate to severe painful crises.
The recommended dose of Siklos is 20 mg/kg once daily.
The FDA granted priority review and orphan drug designation to the application for Siklos.
The agency’s approval of Siklos was based on data from the ESCORT HU study (NCT02516579). The trial was an evaluation of Siklos in 405 patients, ages 2 to 18, with sickle cell disease (SCD).
Thirty-five percent of these patients (n=141) had not received hydroxyurea prior to study enrollment and were therefore evaluable for efficacy. The median follow-up was 23 months (range, 12 to 80 months).
The researchers found that Siklos prompted an increase in fetal hemoglobin. Median fetal hemoglobin percentages were 5.6% (range, 1.3 to 15.0) at baseline and 12.8% (range, 2.1 to 37.2) at around 6 months after Siklos initiation (the value closest to 6 months collected between 5 and 14 months).
In addition, the percentage of patients with at least 1 vaso-occlusive episode, 1 episode of acute chest syndrome, 1 hospitalization due to SCD, or 1 blood transfusion decreased after 12 months of Siklos treatment.
The proportion of patients with at least 1 vaso-occlusive episode was 69.2% at baseline and 42.5% at 12 months. The proportion with at least 1 episode of acute chest syndrome was 23.6% and 5.7%, respectively.
The proportion with at least 1 hospitalization due to SCD was 75.5% and 41.8%, respectively. And the proportion with at least 1 blood transfusion was 45.9% and 23.0%, respectively.
The most common adverse events (occurring in at least 10% of patients) were infections (39.8%), gastrointestinal disorders (13.1%), neutropenia (12.6%), nervous system disorders (11.1%), and metabolic and nutrition disorders (10.9%).
Full prescribing information for Siklos is available on the FDA website. 
The US Food and Drug Administration (FDA) has approved a hydroxyurea product (Addmedica’s Siklos) for use in pediatric patients with sickle cell anemia.
Siklos is intended to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients age 2 and older who have sickle cell anemia and recurrent moderate to severe painful crises.
The recommended dose of Siklos is 20 mg/kg once daily.
The FDA granted priority review and orphan drug designation to the application for Siklos.
The agency’s approval of Siklos was based on data from the ESCORT HU study (NCT02516579). The trial was an evaluation of Siklos in 405 patients, ages 2 to 18, with sickle cell disease (SCD).
Thirty-five percent of these patients (n=141) had not received hydroxyurea prior to study enrollment and were therefore evaluable for efficacy. The median follow-up was 23 months (range, 12 to 80 months).
The researchers found that Siklos prompted an increase in fetal hemoglobin. Median fetal hemoglobin percentages were 5.6% (range, 1.3 to 15.0) at baseline and 12.8% (range, 2.1 to 37.2) at around 6 months after Siklos initiation (the value closest to 6 months collected between 5 and 14 months).
In addition, the percentage of patients with at least 1 vaso-occlusive episode, 1 episode of acute chest syndrome, 1 hospitalization due to SCD, or 1 blood transfusion decreased after 12 months of Siklos treatment.
The proportion of patients with at least 1 vaso-occlusive episode was 69.2% at baseline and 42.5% at 12 months. The proportion with at least 1 episode of acute chest syndrome was 23.6% and 5.7%, respectively.
The proportion with at least 1 hospitalization due to SCD was 75.5% and 41.8%, respectively. And the proportion with at least 1 blood transfusion was 45.9% and 23.0%, respectively.
The most common adverse events (occurring in at least 10% of patients) were infections (39.8%), gastrointestinal disorders (13.1%), neutropenia (12.6%), nervous system disorders (11.1%), and metabolic and nutrition disorders (10.9%).
Full prescribing information for Siklos is available on the FDA website.
The US Food and Drug Administration (FDA) has approved a hydroxyurea product (Addmedica’s Siklos) for use in pediatric patients with sickle cell anemia.
Siklos is intended to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients age 2 and older who have sickle cell anemia and recurrent moderate to severe painful crises.
The recommended dose of Siklos is 20 mg/kg once daily.
The FDA granted priority review and orphan drug designation to the application for Siklos.
The agency’s approval of Siklos was based on data from the ESCORT HU study (NCT02516579). The trial was an evaluation of Siklos in 405 patients, ages 2 to 18, with sickle cell disease (SCD).
Thirty-five percent of these patients (n=141) had not received hydroxyurea prior to study enrollment and were therefore evaluable for efficacy. The median follow-up was 23 months (range, 12 to 80 months).
The researchers found that Siklos prompted an increase in fetal hemoglobin. Median fetal hemoglobin percentages were 5.6% (range, 1.3 to 15.0) at baseline and 12.8% (range, 2.1 to 37.2) at around 6 months after Siklos initiation (the value closest to 6 months collected between 5 and 14 months).
In addition, the percentage of patients with at least 1 vaso-occlusive episode, 1 episode of acute chest syndrome, 1 hospitalization due to SCD, or 1 blood transfusion decreased after 12 months of Siklos treatment.
The proportion of patients with at least 1 vaso-occlusive episode was 69.2% at baseline and 42.5% at 12 months. The proportion with at least 1 episode of acute chest syndrome was 23.6% and 5.7%, respectively.
The proportion with at least 1 hospitalization due to SCD was 75.5% and 41.8%, respectively. And the proportion with at least 1 blood transfusion was 45.9% and 23.0%, respectively.
The most common adverse events (occurring in at least 10% of patients) were infections (39.8%), gastrointestinal disorders (13.1%), neutropenia (12.6%), nervous system disorders (11.1%), and metabolic and nutrition disorders (10.9%).
Full prescribing information for Siklos is available on the FDA website.
When cannabis use becomes another disorder
Despite the justified concern about rising opiate use in the United States, cannabis remains the most commonly used substance in the 12- to 17-year-old population.1 Cannabis use is widespread, particularly in states in which it has been decriminalized or legalized. While use of alcohol and nicotine has fallen among high school students from the years 2010 to 2015, marijuana use has remained relatively constant.2 In addition, the potency of cannabis with regard to tetrahydrocannabinol (THC) content has increased over the years. Despite the common belief among the public that cannabis use is benign, accumulating research is revealing a number of concerning consequences, especially in vulnerable populations and those who use cannabis regularly.
Case summary
Case discussion
Treatment for these adverse effects of cannabis is cessation of the drug. This can be accomplished through hard work with a counselor, who may recommend any of a number of treatments, including contingency management, cognitive behavioral therapy, systematic multidimensional family therapy, and motivational enhancement therapy, among others.5 While common lore is that it is impossible to stop cannabis use, the effect sizes of these treatments is in the moderate to large range. There are viable options to stop cannabis use, especially when it becomes problematic.
Dr. Althoff is associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Email him at pdnews@frontlinemedcom.com.
References
1. “Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings,” Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality, 2013.
2. “Monitoring the Future Survey, 2015,” National Institute on Drug Abuse.
3. Pharmaceuticals (Basel). 2012 Jul;5(7):719-26.
4. Nat Rev Neurosci. 2007 Nov;8(11):885-95.
5. Dtsch Arztebl Int. 2016 Sep;113(39): 653-9.
Despite the justified concern about rising opiate use in the United States, cannabis remains the most commonly used substance in the 12- to 17-year-old population.1 Cannabis use is widespread, particularly in states in which it has been decriminalized or legalized. While use of alcohol and nicotine has fallen among high school students from the years 2010 to 2015, marijuana use has remained relatively constant.2 In addition, the potency of cannabis with regard to tetrahydrocannabinol (THC) content has increased over the years. Despite the common belief among the public that cannabis use is benign, accumulating research is revealing a number of concerning consequences, especially in vulnerable populations and those who use cannabis regularly.
Case summary
Case discussion
Treatment for these adverse effects of cannabis is cessation of the drug. This can be accomplished through hard work with a counselor, who may recommend any of a number of treatments, including contingency management, cognitive behavioral therapy, systematic multidimensional family therapy, and motivational enhancement therapy, among others.5 While common lore is that it is impossible to stop cannabis use, the effect sizes of these treatments is in the moderate to large range. There are viable options to stop cannabis use, especially when it becomes problematic.
Dr. Althoff is associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Email him at pdnews@frontlinemedcom.com.
References
1. “Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings,” Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality, 2013.
2. “Monitoring the Future Survey, 2015,” National Institute on Drug Abuse.
3. Pharmaceuticals (Basel). 2012 Jul;5(7):719-26.
4. Nat Rev Neurosci. 2007 Nov;8(11):885-95.
5. Dtsch Arztebl Int. 2016 Sep;113(39): 653-9.
Despite the justified concern about rising opiate use in the United States, cannabis remains the most commonly used substance in the 12- to 17-year-old population.1 Cannabis use is widespread, particularly in states in which it has been decriminalized or legalized. While use of alcohol and nicotine has fallen among high school students from the years 2010 to 2015, marijuana use has remained relatively constant.2 In addition, the potency of cannabis with regard to tetrahydrocannabinol (THC) content has increased over the years. Despite the common belief among the public that cannabis use is benign, accumulating research is revealing a number of concerning consequences, especially in vulnerable populations and those who use cannabis regularly.
Case summary
Case discussion
Treatment for these adverse effects of cannabis is cessation of the drug. This can be accomplished through hard work with a counselor, who may recommend any of a number of treatments, including contingency management, cognitive behavioral therapy, systematic multidimensional family therapy, and motivational enhancement therapy, among others.5 While common lore is that it is impossible to stop cannabis use, the effect sizes of these treatments is in the moderate to large range. There are viable options to stop cannabis use, especially when it becomes problematic.
Dr. Althoff is associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Email him at pdnews@frontlinemedcom.com.
References
1. “Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings,” Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality, 2013.
2. “Monitoring the Future Survey, 2015,” National Institute on Drug Abuse.
3. Pharmaceuticals (Basel). 2012 Jul;5(7):719-26.
4. Nat Rev Neurosci. 2007 Nov;8(11):885-95.
5. Dtsch Arztebl Int. 2016 Sep;113(39): 653-9.