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Christopher Palmer has been an associate editor at MDedge News since 2017. When he's not tidying grammar, he writes short pieces about breaking FDA announcements and approvals, as well as journal articles. He proudly holds a BA in English and philosophy. Follow him on Twitter @cmacmpalm.
Poststroke hemorrhage risk higher with clopidogrel/aspirin than aspirin
A secondary analysis of the POINT randomized, clinical trial found that the risk of major hemorrhage associated with clopidogrel plus aspirin was higher than that with placebo plus aspirin (0.9% vs. 0.2%; hazard ratio, 3.57; 95% confidence interval, 1.44-8.85; P = .003). The study, which was published in JAMA Neurology, randomized nearly 4,900 patients at centers worldwide and concluded that overall the risk for hemorrhage was low with either treatment, although it did also find higher risk of minor hemorrhage with the combination than aspirin alone.
We previously covered results from POINT when they were presented at the World Stroke Congress, which can be found below.
SOURCE: Tillman H et al. JAMA Neurol. 2019 Apr 29. doi: 10.1001/jamaneurol.2019.0932.
A secondary analysis of the POINT randomized, clinical trial found that the risk of major hemorrhage associated with clopidogrel plus aspirin was higher than that with placebo plus aspirin (0.9% vs. 0.2%; hazard ratio, 3.57; 95% confidence interval, 1.44-8.85; P = .003). The study, which was published in JAMA Neurology, randomized nearly 4,900 patients at centers worldwide and concluded that overall the risk for hemorrhage was low with either treatment, although it did also find higher risk of minor hemorrhage with the combination than aspirin alone.
We previously covered results from POINT when they were presented at the World Stroke Congress, which can be found below.
SOURCE: Tillman H et al. JAMA Neurol. 2019 Apr 29. doi: 10.1001/jamaneurol.2019.0932.
A secondary analysis of the POINT randomized, clinical trial found that the risk of major hemorrhage associated with clopidogrel plus aspirin was higher than that with placebo plus aspirin (0.9% vs. 0.2%; hazard ratio, 3.57; 95% confidence interval, 1.44-8.85; P = .003). The study, which was published in JAMA Neurology, randomized nearly 4,900 patients at centers worldwide and concluded that overall the risk for hemorrhage was low with either treatment, although it did also find higher risk of minor hemorrhage with the combination than aspirin alone.
We previously covered results from POINT when they were presented at the World Stroke Congress, which can be found below.
SOURCE: Tillman H et al. JAMA Neurol. 2019 Apr 29. doi: 10.1001/jamaneurol.2019.0932.
FROM JAMA NEUROLOGY
EU authorization recommended for buprenorphine implant
The European Medicines Agency announced April 26 that its human medicines committee has recommended granting a marketing authorization for Sixmo, a long-lasting implant delivering buprenorphine as treatment for opioid use disorder (OUD).
This recommendation is a step toward making the product available to patients with OUD in the European Union, according to a press release from the EMA. Safety and efficacy of the implant were studied in three trials with a total of 628 patients.
Standard treatment of OUD includes psychological and social counseling, as well as substitution opioid therapy – such as methadone or buprenorphine. The Sixmo implant involves four small rods implanted in the patient’s upper arm under local anesthetic.
The most common adverse events associated with the medicine were in keeping with the known events associated with buprenorphine – headache, constipation, and insomnia. Insertion and removal were associated with pain, severe itching, and hematoma at the implant site.
The full release can be found on the EMA website.
The European Medicines Agency announced April 26 that its human medicines committee has recommended granting a marketing authorization for Sixmo, a long-lasting implant delivering buprenorphine as treatment for opioid use disorder (OUD).
This recommendation is a step toward making the product available to patients with OUD in the European Union, according to a press release from the EMA. Safety and efficacy of the implant were studied in three trials with a total of 628 patients.
Standard treatment of OUD includes psychological and social counseling, as well as substitution opioid therapy – such as methadone or buprenorphine. The Sixmo implant involves four small rods implanted in the patient’s upper arm under local anesthetic.
The most common adverse events associated with the medicine were in keeping with the known events associated with buprenorphine – headache, constipation, and insomnia. Insertion and removal were associated with pain, severe itching, and hematoma at the implant site.
The full release can be found on the EMA website.
The European Medicines Agency announced April 26 that its human medicines committee has recommended granting a marketing authorization for Sixmo, a long-lasting implant delivering buprenorphine as treatment for opioid use disorder (OUD).
This recommendation is a step toward making the product available to patients with OUD in the European Union, according to a press release from the EMA. Safety and efficacy of the implant were studied in three trials with a total of 628 patients.
Standard treatment of OUD includes psychological and social counseling, as well as substitution opioid therapy – such as methadone or buprenorphine. The Sixmo implant involves four small rods implanted in the patient’s upper arm under local anesthetic.
The most common adverse events associated with the medicine were in keeping with the known events associated with buprenorphine – headache, constipation, and insomnia. Insertion and removal were associated with pain, severe itching, and hematoma at the implant site.
The full release can be found on the EMA website.
Deadly overlap of fentanyl and stimulants on the rise
Rates of a potentially deadly overlap between use of nonprescribed fentanyl and use of either cocaine or methamphetamine have been increasing, a cross-sectional study of 1 million urine drug tests shows.
Leah LaRue, PharmD, of Millennium Health in San Diego, and colleagues performed the study, which sampled 1 million urine drug tests submitted by health care professionals “as part of routine care” during Jan. 1, 2013–Sept. 30, 2018. They isolated tests that were positive for either cocaine or methamphetamine – but not positive for both – and then determined how many in each group were also positive for nonprescribed fentanyl. Their analyses showed that the rate of cocaine-positive tests that also were positive for nonprescribed fentanyl increased from 0.9% in 2013 (n = 84; 95% confidence interval, 0.7%-1.1%) to 17.6% in 2018 (n = 427; 95% CI, 16.1%-19.1%), an increase of 1,850% (P less than .001). The rate of methamphetamine-positive tests that also were positive for nonprescribed fentanyl also started at 0.9% in 2013 (n = 29; 95% CI, 0.6%-1.2%) but rose to 7.9% in 2018 (n = 344; 95% CI, 7.1%-8.7%, a 798% increase (P less than .001). The study was published in JAMA Network Open.
The investigators suggested two explanations for these increases: intentional combination of drugs for “speedball effects” of combining stimulants and depressants and/or unintentional exposure on the part of users through contamination of substances. There have been increases in both cocaine-related and methamphetamine-related deaths, and the investigators of this study suspect these increases could be explained in part by overlap with opioids such as fentanyl. Part of the overdose risk inherent in these combinations is that, as the stimulant wears off, the fentanyl increasingly depresses the respiratory system, according to investigators; alternatively, opioid-naive stimulant users might be exposed to high levels of fentanyl with no opioid tolerance, which also can lead to overdose.
The study’s limitations include how samples were submitted – by health care professionals as part of routine care – and the possibility that individuals’ list of prescribed medications could have been incomplete or inaccurate such that the presence of prescribed fentanyl was counted as nonprescribed.
“The combination of nonprescribed fentanyl with cocaine or methamphetamine places an individual at increased risk of overdose,” they concluded.
cpalmer@mdedge.com
SOURCE: LaRue L et al. JAMA Netw Open. 2019 Apr 26. doi: 10.1001/jamanetworkopen.2019.2851.
Rates of a potentially deadly overlap between use of nonprescribed fentanyl and use of either cocaine or methamphetamine have been increasing, a cross-sectional study of 1 million urine drug tests shows.
Leah LaRue, PharmD, of Millennium Health in San Diego, and colleagues performed the study, which sampled 1 million urine drug tests submitted by health care professionals “as part of routine care” during Jan. 1, 2013–Sept. 30, 2018. They isolated tests that were positive for either cocaine or methamphetamine – but not positive for both – and then determined how many in each group were also positive for nonprescribed fentanyl. Their analyses showed that the rate of cocaine-positive tests that also were positive for nonprescribed fentanyl increased from 0.9% in 2013 (n = 84; 95% confidence interval, 0.7%-1.1%) to 17.6% in 2018 (n = 427; 95% CI, 16.1%-19.1%), an increase of 1,850% (P less than .001). The rate of methamphetamine-positive tests that also were positive for nonprescribed fentanyl also started at 0.9% in 2013 (n = 29; 95% CI, 0.6%-1.2%) but rose to 7.9% in 2018 (n = 344; 95% CI, 7.1%-8.7%, a 798% increase (P less than .001). The study was published in JAMA Network Open.
The investigators suggested two explanations for these increases: intentional combination of drugs for “speedball effects” of combining stimulants and depressants and/or unintentional exposure on the part of users through contamination of substances. There have been increases in both cocaine-related and methamphetamine-related deaths, and the investigators of this study suspect these increases could be explained in part by overlap with opioids such as fentanyl. Part of the overdose risk inherent in these combinations is that, as the stimulant wears off, the fentanyl increasingly depresses the respiratory system, according to investigators; alternatively, opioid-naive stimulant users might be exposed to high levels of fentanyl with no opioid tolerance, which also can lead to overdose.
The study’s limitations include how samples were submitted – by health care professionals as part of routine care – and the possibility that individuals’ list of prescribed medications could have been incomplete or inaccurate such that the presence of prescribed fentanyl was counted as nonprescribed.
“The combination of nonprescribed fentanyl with cocaine or methamphetamine places an individual at increased risk of overdose,” they concluded.
cpalmer@mdedge.com
SOURCE: LaRue L et al. JAMA Netw Open. 2019 Apr 26. doi: 10.1001/jamanetworkopen.2019.2851.
Rates of a potentially deadly overlap between use of nonprescribed fentanyl and use of either cocaine or methamphetamine have been increasing, a cross-sectional study of 1 million urine drug tests shows.
Leah LaRue, PharmD, of Millennium Health in San Diego, and colleagues performed the study, which sampled 1 million urine drug tests submitted by health care professionals “as part of routine care” during Jan. 1, 2013–Sept. 30, 2018. They isolated tests that were positive for either cocaine or methamphetamine – but not positive for both – and then determined how many in each group were also positive for nonprescribed fentanyl. Their analyses showed that the rate of cocaine-positive tests that also were positive for nonprescribed fentanyl increased from 0.9% in 2013 (n = 84; 95% confidence interval, 0.7%-1.1%) to 17.6% in 2018 (n = 427; 95% CI, 16.1%-19.1%), an increase of 1,850% (P less than .001). The rate of methamphetamine-positive tests that also were positive for nonprescribed fentanyl also started at 0.9% in 2013 (n = 29; 95% CI, 0.6%-1.2%) but rose to 7.9% in 2018 (n = 344; 95% CI, 7.1%-8.7%, a 798% increase (P less than .001). The study was published in JAMA Network Open.
The investigators suggested two explanations for these increases: intentional combination of drugs for “speedball effects” of combining stimulants and depressants and/or unintentional exposure on the part of users through contamination of substances. There have been increases in both cocaine-related and methamphetamine-related deaths, and the investigators of this study suspect these increases could be explained in part by overlap with opioids such as fentanyl. Part of the overdose risk inherent in these combinations is that, as the stimulant wears off, the fentanyl increasingly depresses the respiratory system, according to investigators; alternatively, opioid-naive stimulant users might be exposed to high levels of fentanyl with no opioid tolerance, which also can lead to overdose.
The study’s limitations include how samples were submitted – by health care professionals as part of routine care – and the possibility that individuals’ list of prescribed medications could have been incomplete or inaccurate such that the presence of prescribed fentanyl was counted as nonprescribed.
“The combination of nonprescribed fentanyl with cocaine or methamphetamine places an individual at increased risk of overdose,” they concluded.
cpalmer@mdedge.com
SOURCE: LaRue L et al. JAMA Netw Open. 2019 Apr 26. doi: 10.1001/jamanetworkopen.2019.2851.
FROM jama network open
FDA approves corticosteroid-retinoid lotion for plaque psoriasis
The in a lotion formulation, for the treatment of plaque psoriasis in adults, the manufacturer announced on April 25.
A press release from the manufacturer, Ortho Dermatologics, summarized the results of two phase 3 studies that compared treatment with the combination product, in 418 adults with moderate to severe plaque psoriasis. At week 8, the proportion of patients who had achieved treatment success – defined as at least a two-grade improvement in Investigator Global Assessment score and a score of “clear” or “almost clear” – was 36% and 45% in the treatment groups, compared with 7% and 13% of those on vehicle, respectively (P less than .001 for both).
The release also refers to a phase 2 study of 212 patients, which found that the combination treatment was more effective in treating plaque psoriasis than was either component separately (J Drugs Dermatol. 2017 Mar 1;16[1]:197-204). By week 8, 52.5% of patients treated with the combination lotion had shown treatment success – compared with 33.3% of those treated with halobetasol, 18.6% of those treated with tazarotene, and 9.7% of those treated with vehicle (P = .033).
Common treatment-related adverse events included treatment site reactions, such as irritation, pain, itching, and folliculitis. Treatment may cause birth defects if used during pregnancy, so a negative pregnancy test should be obtained before treatment begins and effective birth control should be used during treatment.
It will be marketed under the trade name Duobrii and is priced at $825 for a 100-gram tube, according to the press release.
The in a lotion formulation, for the treatment of plaque psoriasis in adults, the manufacturer announced on April 25.
A press release from the manufacturer, Ortho Dermatologics, summarized the results of two phase 3 studies that compared treatment with the combination product, in 418 adults with moderate to severe plaque psoriasis. At week 8, the proportion of patients who had achieved treatment success – defined as at least a two-grade improvement in Investigator Global Assessment score and a score of “clear” or “almost clear” – was 36% and 45% in the treatment groups, compared with 7% and 13% of those on vehicle, respectively (P less than .001 for both).
The release also refers to a phase 2 study of 212 patients, which found that the combination treatment was more effective in treating plaque psoriasis than was either component separately (J Drugs Dermatol. 2017 Mar 1;16[1]:197-204). By week 8, 52.5% of patients treated with the combination lotion had shown treatment success – compared with 33.3% of those treated with halobetasol, 18.6% of those treated with tazarotene, and 9.7% of those treated with vehicle (P = .033).
Common treatment-related adverse events included treatment site reactions, such as irritation, pain, itching, and folliculitis. Treatment may cause birth defects if used during pregnancy, so a negative pregnancy test should be obtained before treatment begins and effective birth control should be used during treatment.
It will be marketed under the trade name Duobrii and is priced at $825 for a 100-gram tube, according to the press release.
The in a lotion formulation, for the treatment of plaque psoriasis in adults, the manufacturer announced on April 25.
A press release from the manufacturer, Ortho Dermatologics, summarized the results of two phase 3 studies that compared treatment with the combination product, in 418 adults with moderate to severe plaque psoriasis. At week 8, the proportion of patients who had achieved treatment success – defined as at least a two-grade improvement in Investigator Global Assessment score and a score of “clear” or “almost clear” – was 36% and 45% in the treatment groups, compared with 7% and 13% of those on vehicle, respectively (P less than .001 for both).
The release also refers to a phase 2 study of 212 patients, which found that the combination treatment was more effective in treating plaque psoriasis than was either component separately (J Drugs Dermatol. 2017 Mar 1;16[1]:197-204). By week 8, 52.5% of patients treated with the combination lotion had shown treatment success – compared with 33.3% of those treated with halobetasol, 18.6% of those treated with tazarotene, and 9.7% of those treated with vehicle (P = .033).
Common treatment-related adverse events included treatment site reactions, such as irritation, pain, itching, and folliculitis. Treatment may cause birth defects if used during pregnancy, so a negative pregnancy test should be obtained before treatment begins and effective birth control should be used during treatment.
It will be marketed under the trade name Duobrii and is priced at $825 for a 100-gram tube, according to the press release.
Text messaging may help patients with schizophrenia
A text messaging–based mobile health (mHealth) intervention that relied on lay health supporters improved medication adherence among rural Chinese patients with schizophrenia by 27%, according to results of a study published in PLoS Medicine.
The researchers developed a mHealth protocol intervention that used text messaging and lay health supporters to help patients with schizophrenia to transition from facility-based care to community-based care. The study randomized 278 community-dwelling villagers with schizophrenia to receive care through a community-based free-medicine program either with or without support from the mHealth intervention. Among the 271 patients successfully followed, medication adherence – the primary outcome – was higher in the mHealth group than it was in the control group (adjusted mean difference, 0.12; 95% confidence interval, 0.03-0.22; P = .013).
The investigators wrote that the treatment gaps for schizophrenia in resource-poor areas remain substantial and that text messaging plus lay health support could form a simple and low-cost means of improving the situation in these settings.
SOURCE: Xu D et al. PLoS Med. 2019 Apr 23. doi: 10.1371/journal.pmed.1002785.
A text messaging–based mobile health (mHealth) intervention that relied on lay health supporters improved medication adherence among rural Chinese patients with schizophrenia by 27%, according to results of a study published in PLoS Medicine.
The researchers developed a mHealth protocol intervention that used text messaging and lay health supporters to help patients with schizophrenia to transition from facility-based care to community-based care. The study randomized 278 community-dwelling villagers with schizophrenia to receive care through a community-based free-medicine program either with or without support from the mHealth intervention. Among the 271 patients successfully followed, medication adherence – the primary outcome – was higher in the mHealth group than it was in the control group (adjusted mean difference, 0.12; 95% confidence interval, 0.03-0.22; P = .013).
The investigators wrote that the treatment gaps for schizophrenia in resource-poor areas remain substantial and that text messaging plus lay health support could form a simple and low-cost means of improving the situation in these settings.
SOURCE: Xu D et al. PLoS Med. 2019 Apr 23. doi: 10.1371/journal.pmed.1002785.
A text messaging–based mobile health (mHealth) intervention that relied on lay health supporters improved medication adherence among rural Chinese patients with schizophrenia by 27%, according to results of a study published in PLoS Medicine.
The researchers developed a mHealth protocol intervention that used text messaging and lay health supporters to help patients with schizophrenia to transition from facility-based care to community-based care. The study randomized 278 community-dwelling villagers with schizophrenia to receive care through a community-based free-medicine program either with or without support from the mHealth intervention. Among the 271 patients successfully followed, medication adherence – the primary outcome – was higher in the mHealth group than it was in the control group (adjusted mean difference, 0.12; 95% confidence interval, 0.03-0.22; P = .013).
The investigators wrote that the treatment gaps for schizophrenia in resource-poor areas remain substantial and that text messaging plus lay health support could form a simple and low-cost means of improving the situation in these settings.
SOURCE: Xu D et al. PLoS Med. 2019 Apr 23. doi: 10.1371/journal.pmed.1002785.
FROM PLOS MEDICINE
Changing attitudes, perceived norms promote safe sleep in mothers
related to these practices, according to a new study.
In the past, the American Academy of Pediatrics has made safe sleep recommendations regarding infant sleep position and location. According to the new study’s authors, Rachel Y. Moon, MD, and her colleagues, parents had poorly adhered to these recommendations in several studies. However, some improvements with adherence were seen when a mobile health intervention was used in the Social Media and Risk Reduction Training Study (JAMA. 2017;318[4]:351-9). The new study, published in Pediatrics, used the same intervention described in that JAMA paper.
The more recent mobile health project sought to identify which factors, as outlined by a theory of planned behavior, were affected by a mobile health intervention through analysis of survey responses. Of the 1,600 women who provided written consent, 1,263 (78.9%) completed the survey.
According to the results, the intervention did more to affect attitudes (adjusted odds ratio, 2.35; 95% confidence interval, 1.72-3.20) than it did to affect perceived norms (aOR, 1.75; 95% CI, 1.27-2.36) regarding supine sleeping position. It had similar effects on attitudes (aOR, 1.91; 95% CI, 1.54-2.36) versus perceived norms (aOR, 1.37; 95% CI, 1.13-1.66) regarding sleep location as well. The intervention had no significant effect on perceived maternal control regarding either sleeping position or location.
While levels of safe sleep adherence were lower in African Americans and subgroups of low economic status at baseline, the intervention improved the rates of adherence in these groups to levels comparable with other groups included in the study.
“Recognition that these attitudes and social norms may be the main drivers of mothers’ choices regarding infant-sleep practices should inform health messaging strategies, including the use of [mobile heath], to promote [safe sleep],” the researchers concluded.
The study was funded by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the CJ foundation for sudden infant death syndrome. The National Institutes of Health also provided funding.
SOURCE: Moon RY et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2799.
related to these practices, according to a new study.
In the past, the American Academy of Pediatrics has made safe sleep recommendations regarding infant sleep position and location. According to the new study’s authors, Rachel Y. Moon, MD, and her colleagues, parents had poorly adhered to these recommendations in several studies. However, some improvements with adherence were seen when a mobile health intervention was used in the Social Media and Risk Reduction Training Study (JAMA. 2017;318[4]:351-9). The new study, published in Pediatrics, used the same intervention described in that JAMA paper.
The more recent mobile health project sought to identify which factors, as outlined by a theory of planned behavior, were affected by a mobile health intervention through analysis of survey responses. Of the 1,600 women who provided written consent, 1,263 (78.9%) completed the survey.
According to the results, the intervention did more to affect attitudes (adjusted odds ratio, 2.35; 95% confidence interval, 1.72-3.20) than it did to affect perceived norms (aOR, 1.75; 95% CI, 1.27-2.36) regarding supine sleeping position. It had similar effects on attitudes (aOR, 1.91; 95% CI, 1.54-2.36) versus perceived norms (aOR, 1.37; 95% CI, 1.13-1.66) regarding sleep location as well. The intervention had no significant effect on perceived maternal control regarding either sleeping position or location.
While levels of safe sleep adherence were lower in African Americans and subgroups of low economic status at baseline, the intervention improved the rates of adherence in these groups to levels comparable with other groups included in the study.
“Recognition that these attitudes and social norms may be the main drivers of mothers’ choices regarding infant-sleep practices should inform health messaging strategies, including the use of [mobile heath], to promote [safe sleep],” the researchers concluded.
The study was funded by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the CJ foundation for sudden infant death syndrome. The National Institutes of Health also provided funding.
SOURCE: Moon RY et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2799.
related to these practices, according to a new study.
In the past, the American Academy of Pediatrics has made safe sleep recommendations regarding infant sleep position and location. According to the new study’s authors, Rachel Y. Moon, MD, and her colleagues, parents had poorly adhered to these recommendations in several studies. However, some improvements with adherence were seen when a mobile health intervention was used in the Social Media and Risk Reduction Training Study (JAMA. 2017;318[4]:351-9). The new study, published in Pediatrics, used the same intervention described in that JAMA paper.
The more recent mobile health project sought to identify which factors, as outlined by a theory of planned behavior, were affected by a mobile health intervention through analysis of survey responses. Of the 1,600 women who provided written consent, 1,263 (78.9%) completed the survey.
According to the results, the intervention did more to affect attitudes (adjusted odds ratio, 2.35; 95% confidence interval, 1.72-3.20) than it did to affect perceived norms (aOR, 1.75; 95% CI, 1.27-2.36) regarding supine sleeping position. It had similar effects on attitudes (aOR, 1.91; 95% CI, 1.54-2.36) versus perceived norms (aOR, 1.37; 95% CI, 1.13-1.66) regarding sleep location as well. The intervention had no significant effect on perceived maternal control regarding either sleeping position or location.
While levels of safe sleep adherence were lower in African Americans and subgroups of low economic status at baseline, the intervention improved the rates of adherence in these groups to levels comparable with other groups included in the study.
“Recognition that these attitudes and social norms may be the main drivers of mothers’ choices regarding infant-sleep practices should inform health messaging strategies, including the use of [mobile heath], to promote [safe sleep],” the researchers concluded.
The study was funded by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the CJ foundation for sudden infant death syndrome. The National Institutes of Health also provided funding.
SOURCE: Moon RY et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2799.
FROM PEDIATRICS
Postvaccination febrile seizures are no more severe than other febrile seizures
according to a study in Pediatrics.
Lucy Deng, MBBS, of the University of Sydney and her colleagues investigated 1,022 index febrile seizures in children aged 6 years or less, of which 6% (n = 67) were VP-FSs and 94% (n = 955) were NVP-FSs. Both univariate and multivariate analyses showed no increased risk of severe seizure associated with VP-FSs, compared with NVP-FS. Most of the febrile seizures of either type were brief (15 minutes or less) and had a length of stay of 1 day or less; there also were no differences in 24-hour recurrence. The most common symptom was respiratory, and the rates were similar in each group (62.7% with VP-FS vs. 62.8% with NVP-FS). In keeping with a known 100% increased risk associated with measles vaccination, 84% of VP-FSs were associated with measles-containing vaccines. The majority of the remaining VP-FSs occurred after combination vaccines.
One limitation is that, because these cases were documented in sentinel tertiary pediatric hospitals, the case ascertainment may not be representative. Also, the small proportion of VP-FSs and limited cohort size means the study may not have been powered to detect true differences in prolonged seizures between the groups, Dr. Deng and her colleagues wrote.
“This study confirms that VP-FSs are clinically not any different from NVP-FSs and should be managed the same way,” the researchers concluded.
The authors reported no relevant financial disclosures, although Dr. Deng is supported by the University of Sydney Training Program scholarship, and two other study authors are supported by Australian National Health and Medical Research Council Career Development Fellowships. The study was funded by a grant from the Australian Government Department of Health and the National Health and Medical Research Council.
SOURCE: Deng L et al. Pediatrics. 2019 Apr 19. doi: 10.1542/peds.2018-2120.
according to a study in Pediatrics.
Lucy Deng, MBBS, of the University of Sydney and her colleagues investigated 1,022 index febrile seizures in children aged 6 years or less, of which 6% (n = 67) were VP-FSs and 94% (n = 955) were NVP-FSs. Both univariate and multivariate analyses showed no increased risk of severe seizure associated with VP-FSs, compared with NVP-FS. Most of the febrile seizures of either type were brief (15 minutes or less) and had a length of stay of 1 day or less; there also were no differences in 24-hour recurrence. The most common symptom was respiratory, and the rates were similar in each group (62.7% with VP-FS vs. 62.8% with NVP-FS). In keeping with a known 100% increased risk associated with measles vaccination, 84% of VP-FSs were associated with measles-containing vaccines. The majority of the remaining VP-FSs occurred after combination vaccines.
One limitation is that, because these cases were documented in sentinel tertiary pediatric hospitals, the case ascertainment may not be representative. Also, the small proportion of VP-FSs and limited cohort size means the study may not have been powered to detect true differences in prolonged seizures between the groups, Dr. Deng and her colleagues wrote.
“This study confirms that VP-FSs are clinically not any different from NVP-FSs and should be managed the same way,” the researchers concluded.
The authors reported no relevant financial disclosures, although Dr. Deng is supported by the University of Sydney Training Program scholarship, and two other study authors are supported by Australian National Health and Medical Research Council Career Development Fellowships. The study was funded by a grant from the Australian Government Department of Health and the National Health and Medical Research Council.
SOURCE: Deng L et al. Pediatrics. 2019 Apr 19. doi: 10.1542/peds.2018-2120.
according to a study in Pediatrics.
Lucy Deng, MBBS, of the University of Sydney and her colleagues investigated 1,022 index febrile seizures in children aged 6 years or less, of which 6% (n = 67) were VP-FSs and 94% (n = 955) were NVP-FSs. Both univariate and multivariate analyses showed no increased risk of severe seizure associated with VP-FSs, compared with NVP-FS. Most of the febrile seizures of either type were brief (15 minutes or less) and had a length of stay of 1 day or less; there also were no differences in 24-hour recurrence. The most common symptom was respiratory, and the rates were similar in each group (62.7% with VP-FS vs. 62.8% with NVP-FS). In keeping with a known 100% increased risk associated with measles vaccination, 84% of VP-FSs were associated with measles-containing vaccines. The majority of the remaining VP-FSs occurred after combination vaccines.
One limitation is that, because these cases were documented in sentinel tertiary pediatric hospitals, the case ascertainment may not be representative. Also, the small proportion of VP-FSs and limited cohort size means the study may not have been powered to detect true differences in prolonged seizures between the groups, Dr. Deng and her colleagues wrote.
“This study confirms that VP-FSs are clinically not any different from NVP-FSs and should be managed the same way,” the researchers concluded.
The authors reported no relevant financial disclosures, although Dr. Deng is supported by the University of Sydney Training Program scholarship, and two other study authors are supported by Australian National Health and Medical Research Council Career Development Fellowships. The study was funded by a grant from the Australian Government Department of Health and the National Health and Medical Research Council.
SOURCE: Deng L et al. Pediatrics. 2019 Apr 19. doi: 10.1542/peds.2018-2120.
FROM PEDIATRICS
Rate of objects ingested by young children increased over last two decades
– from an estimated 9 cases per 10,000 children to 18 cases per 10,000 (R2 = 0.90; P less than .001) – according to an analysis in Pediatrics.
The analysis was conducted by Danielle Orsagh-Yentis, MD, of Vanderbilt University, Nashville, Tenn., and her colleagues. They estimated that, during the study period, 759,074 children younger than 6 years of age were evaluated in U.S. EDs for suspected or confirmed foreign-body ingestions. These estimates were based on data for 29,893 actual cases taken from the National Electronic Injury Surveillance System (NEISS), which represents about 100 hospitals. Each case in this system is given a sample weight by the Consumer Product Safety Commission using a validated method, and the estimates are based on this weighting.
The analysis showed that children aged 1 year (21%) and boys (53%) were the most likely to ingest foreign bodies. Coins were the most frequently ingested objects, at 62%. Among cases which had the location noted (59%), most ingestions occurred in the home (97%).
The authors noted that, although batteries and magnets represented only 7% and 2% of all cases, respectively, “they can both enact considerable damage when ingested.” For example, despite being only the fourth mostly likely object to be ingested, batteries were the second mostly likely to be implicated among hospitalized patients.
The authors noted that the NEISS captures patients in the ED only; the total number of foreign-body ingestions, then, was likely underestimated. Despite this, the authors felt the long study period and large sample were strengths of their analysis.
Dr. Orsagh-Yentis and her associates disclosed no potential conflicts of interest.
SOURCE: Orsagh-Yentis D et al. Pediatrics. 2019 Apr 12. doi: 10.1542/peds.2018-1988.
– from an estimated 9 cases per 10,000 children to 18 cases per 10,000 (R2 = 0.90; P less than .001) – according to an analysis in Pediatrics.
The analysis was conducted by Danielle Orsagh-Yentis, MD, of Vanderbilt University, Nashville, Tenn., and her colleagues. They estimated that, during the study period, 759,074 children younger than 6 years of age were evaluated in U.S. EDs for suspected or confirmed foreign-body ingestions. These estimates were based on data for 29,893 actual cases taken from the National Electronic Injury Surveillance System (NEISS), which represents about 100 hospitals. Each case in this system is given a sample weight by the Consumer Product Safety Commission using a validated method, and the estimates are based on this weighting.
The analysis showed that children aged 1 year (21%) and boys (53%) were the most likely to ingest foreign bodies. Coins were the most frequently ingested objects, at 62%. Among cases which had the location noted (59%), most ingestions occurred in the home (97%).
The authors noted that, although batteries and magnets represented only 7% and 2% of all cases, respectively, “they can both enact considerable damage when ingested.” For example, despite being only the fourth mostly likely object to be ingested, batteries were the second mostly likely to be implicated among hospitalized patients.
The authors noted that the NEISS captures patients in the ED only; the total number of foreign-body ingestions, then, was likely underestimated. Despite this, the authors felt the long study period and large sample were strengths of their analysis.
Dr. Orsagh-Yentis and her associates disclosed no potential conflicts of interest.
SOURCE: Orsagh-Yentis D et al. Pediatrics. 2019 Apr 12. doi: 10.1542/peds.2018-1988.
– from an estimated 9 cases per 10,000 children to 18 cases per 10,000 (R2 = 0.90; P less than .001) – according to an analysis in Pediatrics.
The analysis was conducted by Danielle Orsagh-Yentis, MD, of Vanderbilt University, Nashville, Tenn., and her colleagues. They estimated that, during the study period, 759,074 children younger than 6 years of age were evaluated in U.S. EDs for suspected or confirmed foreign-body ingestions. These estimates were based on data for 29,893 actual cases taken from the National Electronic Injury Surveillance System (NEISS), which represents about 100 hospitals. Each case in this system is given a sample weight by the Consumer Product Safety Commission using a validated method, and the estimates are based on this weighting.
The analysis showed that children aged 1 year (21%) and boys (53%) were the most likely to ingest foreign bodies. Coins were the most frequently ingested objects, at 62%. Among cases which had the location noted (59%), most ingestions occurred in the home (97%).
The authors noted that, although batteries and magnets represented only 7% and 2% of all cases, respectively, “they can both enact considerable damage when ingested.” For example, despite being only the fourth mostly likely object to be ingested, batteries were the second mostly likely to be implicated among hospitalized patients.
The authors noted that the NEISS captures patients in the ED only; the total number of foreign-body ingestions, then, was likely underestimated. Despite this, the authors felt the long study period and large sample were strengths of their analysis.
Dr. Orsagh-Yentis and her associates disclosed no potential conflicts of interest.
SOURCE: Orsagh-Yentis D et al. Pediatrics. 2019 Apr 12. doi: 10.1542/peds.2018-1988.
FROM PEDIATRICS
FDA modifies safety label for Addyi
The Food and Drug Administration has issued a safety labeling change for flibanserin (Addyi), a treatment for premenopausal women with acquired, generalized hypoactive sexual desire disorder, according to a press release issued April 11 by the agency. Previously, the warning said women should abstain from alcohol entirely.
According to the release, the manufacturer, Sprout, had hoped the FDA would remove the boxed warning and contraindication entirely. However, based on a review of two postmarket research studies, the agency chose to order these modifications to the warnings instead.
The first postmarket study was missing information related to participants’ blood pressure, which FDA officials thought was critical in determining risk; it appeared that this resulted from safety precautions built into the trial. The concern was that not only did this absent information provide further evidence of an interaction but that women at home would not have the benefit of these safety precautions and could suffer serious outcomes, including falls, accidents, and bodily harm. The other postmarketing trial showed that delaying administration of flibanserin until at least 2 hours after consuming alcohol reduced the risk of serious hypotension and syncope.
It is recommended that flibanserin be taken at bedtime because of risks associated with hypotension and syncope, as well as risks associated with central nervous system depression (such as sleepiness). Furthermore, patients are encouraged to discontinue treatment with flibanserin if their hypoactive sexual desire disorder does not improve after 8 weeks. The most common adverse reactions include dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.
Full prescribing information is available on the FDA website, as is the full release regarding these safety label modifications.
The Food and Drug Administration has issued a safety labeling change for flibanserin (Addyi), a treatment for premenopausal women with acquired, generalized hypoactive sexual desire disorder, according to a press release issued April 11 by the agency. Previously, the warning said women should abstain from alcohol entirely.
According to the release, the manufacturer, Sprout, had hoped the FDA would remove the boxed warning and contraindication entirely. However, based on a review of two postmarket research studies, the agency chose to order these modifications to the warnings instead.
The first postmarket study was missing information related to participants’ blood pressure, which FDA officials thought was critical in determining risk; it appeared that this resulted from safety precautions built into the trial. The concern was that not only did this absent information provide further evidence of an interaction but that women at home would not have the benefit of these safety precautions and could suffer serious outcomes, including falls, accidents, and bodily harm. The other postmarketing trial showed that delaying administration of flibanserin until at least 2 hours after consuming alcohol reduced the risk of serious hypotension and syncope.
It is recommended that flibanserin be taken at bedtime because of risks associated with hypotension and syncope, as well as risks associated with central nervous system depression (such as sleepiness). Furthermore, patients are encouraged to discontinue treatment with flibanserin if their hypoactive sexual desire disorder does not improve after 8 weeks. The most common adverse reactions include dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.
Full prescribing information is available on the FDA website, as is the full release regarding these safety label modifications.
The Food and Drug Administration has issued a safety labeling change for flibanserin (Addyi), a treatment for premenopausal women with acquired, generalized hypoactive sexual desire disorder, according to a press release issued April 11 by the agency. Previously, the warning said women should abstain from alcohol entirely.
According to the release, the manufacturer, Sprout, had hoped the FDA would remove the boxed warning and contraindication entirely. However, based on a review of two postmarket research studies, the agency chose to order these modifications to the warnings instead.
The first postmarket study was missing information related to participants’ blood pressure, which FDA officials thought was critical in determining risk; it appeared that this resulted from safety precautions built into the trial. The concern was that not only did this absent information provide further evidence of an interaction but that women at home would not have the benefit of these safety precautions and could suffer serious outcomes, including falls, accidents, and bodily harm. The other postmarketing trial showed that delaying administration of flibanserin until at least 2 hours after consuming alcohol reduced the risk of serious hypotension and syncope.
It is recommended that flibanserin be taken at bedtime because of risks associated with hypotension and syncope, as well as risks associated with central nervous system depression (such as sleepiness). Furthermore, patients are encouraged to discontinue treatment with flibanserin if their hypoactive sexual desire disorder does not improve after 8 weeks. The most common adverse reactions include dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.
Full prescribing information is available on the FDA website, as is the full release regarding these safety label modifications.
Romosozumab gets FDA approval for treating osteoporosis
“These are women who have a history of osteoporotic fracture or multiple risk factors or have failed other treatments for osteoporosis,” according to a news release from the agency.
The monthly treatment of two injections (given one after the other at one visit) mainly works by increasing new bone formation, but these effects wane after 12 doses. If patients still need osteoporosis therapy after that maximum of 12 doses, it’s recommended they are put on treatments that reduce bone breakdown. Romosozumab-aqqg is “a monoclonal antibody that blocks the effects of the protein sclerostin,” according to the news release.
The treatment’s efficacy and safety was evaluated in two clinical trials of more than 11,000 women with postmenopausal osteoporosis. In one trial, women received 12 months of either romosozumab-aqqg or placebo. The treatment arm had a 73% lower risk of vertebral fracture than did the placebo arm, and this benefit was maintained over a second year when both groups were switched to denosumab, another osteoporosis therapy. In the second trial, one group received romosozumab-aqqg for 1 year and then a year of alendronate, and the other group received 2 years of alendronate, another osteoporosis therapy, according to the news release. In this trial, the romosozumab-aqqg arm had 50% less risk of vertebral fractures than did the alendronate-only arm, as well as reduced risk of nonvertebral fractures.
Romosozumab-aqqg was associated with higher risks of cardiovascular death, heart attack, and stroke in the alendronate trial, so the treatment comes with a boxed warning regarding those risks and recommends that the drug not be used in patients who have had a heart attack or stroke within the previous year, according to the news release. Common side effects include joint pain and headache, as well as injection-site reactions.
“These are women who have a history of osteoporotic fracture or multiple risk factors or have failed other treatments for osteoporosis,” according to a news release from the agency.
The monthly treatment of two injections (given one after the other at one visit) mainly works by increasing new bone formation, but these effects wane after 12 doses. If patients still need osteoporosis therapy after that maximum of 12 doses, it’s recommended they are put on treatments that reduce bone breakdown. Romosozumab-aqqg is “a monoclonal antibody that blocks the effects of the protein sclerostin,” according to the news release.
The treatment’s efficacy and safety was evaluated in two clinical trials of more than 11,000 women with postmenopausal osteoporosis. In one trial, women received 12 months of either romosozumab-aqqg or placebo. The treatment arm had a 73% lower risk of vertebral fracture than did the placebo arm, and this benefit was maintained over a second year when both groups were switched to denosumab, another osteoporosis therapy. In the second trial, one group received romosozumab-aqqg for 1 year and then a year of alendronate, and the other group received 2 years of alendronate, another osteoporosis therapy, according to the news release. In this trial, the romosozumab-aqqg arm had 50% less risk of vertebral fractures than did the alendronate-only arm, as well as reduced risk of nonvertebral fractures.
Romosozumab-aqqg was associated with higher risks of cardiovascular death, heart attack, and stroke in the alendronate trial, so the treatment comes with a boxed warning regarding those risks and recommends that the drug not be used in patients who have had a heart attack or stroke within the previous year, according to the news release. Common side effects include joint pain and headache, as well as injection-site reactions.
“These are women who have a history of osteoporotic fracture or multiple risk factors or have failed other treatments for osteoporosis,” according to a news release from the agency.
The monthly treatment of two injections (given one after the other at one visit) mainly works by increasing new bone formation, but these effects wane after 12 doses. If patients still need osteoporosis therapy after that maximum of 12 doses, it’s recommended they are put on treatments that reduce bone breakdown. Romosozumab-aqqg is “a monoclonal antibody that blocks the effects of the protein sclerostin,” according to the news release.
The treatment’s efficacy and safety was evaluated in two clinical trials of more than 11,000 women with postmenopausal osteoporosis. In one trial, women received 12 months of either romosozumab-aqqg or placebo. The treatment arm had a 73% lower risk of vertebral fracture than did the placebo arm, and this benefit was maintained over a second year when both groups were switched to denosumab, another osteoporosis therapy. In the second trial, one group received romosozumab-aqqg for 1 year and then a year of alendronate, and the other group received 2 years of alendronate, another osteoporosis therapy, according to the news release. In this trial, the romosozumab-aqqg arm had 50% less risk of vertebral fractures than did the alendronate-only arm, as well as reduced risk of nonvertebral fractures.
Romosozumab-aqqg was associated with higher risks of cardiovascular death, heart attack, and stroke in the alendronate trial, so the treatment comes with a boxed warning regarding those risks and recommends that the drug not be used in patients who have had a heart attack or stroke within the previous year, according to the news release. Common side effects include joint pain and headache, as well as injection-site reactions.