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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.
FDA approves Tula system for recurrent pediatric ear infections
The Food and Drug Administration has approved the Tubes Under Local Anesthesia (Tula) System for treatment of recurrent ear infections (otitis media) via tympanostomy in young children, according to a release from the agency.
Consisting of Tymbion anesthetic, tympanostomy tubes developed by Tusker Medical, and several devices that deliver them into the ear drum,
“This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
The approval was based on data from 222 children treated with the device, with a procedural success rate of 86% in children under 5 years and 89% in children aged 5-12 years. The most common adverse event was insufficient anesthetic.
The system should not be used in children with allergies to some local anesthetics or those younger than 6 months. It also is not intended for patients with preexisting issues with their eardrums, such as perforated ear drums, according to the press release.
The Tula system was granted a Breakthrough Device designation, which means the FDA provided intensive engagement and guidance during its development. The full release can be found on the FDA website.
The Food and Drug Administration has approved the Tubes Under Local Anesthesia (Tula) System for treatment of recurrent ear infections (otitis media) via tympanostomy in young children, according to a release from the agency.
Consisting of Tymbion anesthetic, tympanostomy tubes developed by Tusker Medical, and several devices that deliver them into the ear drum,
“This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
The approval was based on data from 222 children treated with the device, with a procedural success rate of 86% in children under 5 years and 89% in children aged 5-12 years. The most common adverse event was insufficient anesthetic.
The system should not be used in children with allergies to some local anesthetics or those younger than 6 months. It also is not intended for patients with preexisting issues with their eardrums, such as perforated ear drums, according to the press release.
The Tula system was granted a Breakthrough Device designation, which means the FDA provided intensive engagement and guidance during its development. The full release can be found on the FDA website.
The Food and Drug Administration has approved the Tubes Under Local Anesthesia (Tula) System for treatment of recurrent ear infections (otitis media) via tympanostomy in young children, according to a release from the agency.
Consisting of Tymbion anesthetic, tympanostomy tubes developed by Tusker Medical, and several devices that deliver them into the ear drum,
“This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
The approval was based on data from 222 children treated with the device, with a procedural success rate of 86% in children under 5 years and 89% in children aged 5-12 years. The most common adverse event was insufficient anesthetic.
The system should not be used in children with allergies to some local anesthetics or those younger than 6 months. It also is not intended for patients with preexisting issues with their eardrums, such as perforated ear drums, according to the press release.
The Tula system was granted a Breakthrough Device designation, which means the FDA provided intensive engagement and guidance during its development. The full release can be found on the FDA website.
Blunted ventral striatal responses found in remitted bipolar I
People with remitted bipolar I disorder appear to show lower rather than higher activity in the ventral striatum in anticipation of monetary gains, compared with controls, results of a small study suggest. In addition, associations were found between positive urgency measure (PUM) and blunted activity in the nucleus accumbens in individuals with bipolar I.
“Together, these findings suggest that individuals with remitted bipolar disorder show blunted ventral striatal responses during anticipation of conventional rewards (e.g., money),” wrote lead author Sheri L. Johnson, PhD, and associates. The study was published in Neuroimage: Clinical.
Dr. Johnson’s team recruited the participants through advertisements online and in the community. Their study included 24 people with bipolar I (14 men; mean age, 36.22 years) and 24 controls without bipolar (13 men; mean age, 33.92 years), reported Dr. Johnson, of the University of California, Berkeley, and associates. The investigators used a version of the Monetary Incentive Delay Task to elicit neural and behavioral responses and their outcomes during fMRI.
Whole brain analyses found that, compared with the control group, those in the bipolar group “showed less activity for the gain anticipation contrast specifically in the ventral striatum (including the right [nucleus accumbens] and right globus pallidus), as well as less activity for the gain outcome contrast in the left occipital gyrus,” the investigators wrote.
PUM, a dimensional trait, was designed to assess tendencies to act “regrettably” or “impulsively” during states of positive emotion. PUM scores have been correlated with outcomes such as lower functioning in behavior, decreased quality of life, and worse outcomes in bipolar disorder. The investigators hoped that, by including PUM to help evaluate group differences, they could account for inconsistent findings regarding associations of neural imaging and reward responses.
“The current findings imply that, in individuals with bipolar disorder, individual differences in PUM may also help account for blunted [nucleus accumbens] during reward anticipation.”
The study’s sample size limited the power to detect small effects or interactions. The researchers felt, though, that the sample was well matched and adequately powered for the primary variables of interest.
The authors had no conflicts of interest to disclose. The study was funded by a grant from the National Institute of Mental Health.
SOURCE: Johnson SL et al. Neuroimage Clin. 2019. doi: 10.1016/j.nicl.2019.102018.
People with remitted bipolar I disorder appear to show lower rather than higher activity in the ventral striatum in anticipation of monetary gains, compared with controls, results of a small study suggest. In addition, associations were found between positive urgency measure (PUM) and blunted activity in the nucleus accumbens in individuals with bipolar I.
“Together, these findings suggest that individuals with remitted bipolar disorder show blunted ventral striatal responses during anticipation of conventional rewards (e.g., money),” wrote lead author Sheri L. Johnson, PhD, and associates. The study was published in Neuroimage: Clinical.
Dr. Johnson’s team recruited the participants through advertisements online and in the community. Their study included 24 people with bipolar I (14 men; mean age, 36.22 years) and 24 controls without bipolar (13 men; mean age, 33.92 years), reported Dr. Johnson, of the University of California, Berkeley, and associates. The investigators used a version of the Monetary Incentive Delay Task to elicit neural and behavioral responses and their outcomes during fMRI.
Whole brain analyses found that, compared with the control group, those in the bipolar group “showed less activity for the gain anticipation contrast specifically in the ventral striatum (including the right [nucleus accumbens] and right globus pallidus), as well as less activity for the gain outcome contrast in the left occipital gyrus,” the investigators wrote.
PUM, a dimensional trait, was designed to assess tendencies to act “regrettably” or “impulsively” during states of positive emotion. PUM scores have been correlated with outcomes such as lower functioning in behavior, decreased quality of life, and worse outcomes in bipolar disorder. The investigators hoped that, by including PUM to help evaluate group differences, they could account for inconsistent findings regarding associations of neural imaging and reward responses.
“The current findings imply that, in individuals with bipolar disorder, individual differences in PUM may also help account for blunted [nucleus accumbens] during reward anticipation.”
The study’s sample size limited the power to detect small effects or interactions. The researchers felt, though, that the sample was well matched and adequately powered for the primary variables of interest.
The authors had no conflicts of interest to disclose. The study was funded by a grant from the National Institute of Mental Health.
SOURCE: Johnson SL et al. Neuroimage Clin. 2019. doi: 10.1016/j.nicl.2019.102018.
People with remitted bipolar I disorder appear to show lower rather than higher activity in the ventral striatum in anticipation of monetary gains, compared with controls, results of a small study suggest. In addition, associations were found between positive urgency measure (PUM) and blunted activity in the nucleus accumbens in individuals with bipolar I.
“Together, these findings suggest that individuals with remitted bipolar disorder show blunted ventral striatal responses during anticipation of conventional rewards (e.g., money),” wrote lead author Sheri L. Johnson, PhD, and associates. The study was published in Neuroimage: Clinical.
Dr. Johnson’s team recruited the participants through advertisements online and in the community. Their study included 24 people with bipolar I (14 men; mean age, 36.22 years) and 24 controls without bipolar (13 men; mean age, 33.92 years), reported Dr. Johnson, of the University of California, Berkeley, and associates. The investigators used a version of the Monetary Incentive Delay Task to elicit neural and behavioral responses and their outcomes during fMRI.
Whole brain analyses found that, compared with the control group, those in the bipolar group “showed less activity for the gain anticipation contrast specifically in the ventral striatum (including the right [nucleus accumbens] and right globus pallidus), as well as less activity for the gain outcome contrast in the left occipital gyrus,” the investigators wrote.
PUM, a dimensional trait, was designed to assess tendencies to act “regrettably” or “impulsively” during states of positive emotion. PUM scores have been correlated with outcomes such as lower functioning in behavior, decreased quality of life, and worse outcomes in bipolar disorder. The investigators hoped that, by including PUM to help evaluate group differences, they could account for inconsistent findings regarding associations of neural imaging and reward responses.
“The current findings imply that, in individuals with bipolar disorder, individual differences in PUM may also help account for blunted [nucleus accumbens] during reward anticipation.”
The study’s sample size limited the power to detect small effects or interactions. The researchers felt, though, that the sample was well matched and adequately powered for the primary variables of interest.
The authors had no conflicts of interest to disclose. The study was funded by a grant from the National Institute of Mental Health.
SOURCE: Johnson SL et al. Neuroimage Clin. 2019. doi: 10.1016/j.nicl.2019.102018.
FROM NEUROIMAGE: CLINICAL
Chronic pain more common in women with ADHD or ASD
Women with ADHD, autism spectrum disorder (ASD), or both report higher rates of chronic pain, which should be accounted for in the treatment received, new research shows.
In some cases, treating the ADHD might lower the pain, reported Karin Asztély of the Sahlgrenska Academy Institute of Neuroscience, Göteborg, Sweden, and associates. The study was published in the Journal of Pain Research.
The research included 77 Swedish women with ADHD, ASD, or both from a larger prospective longitudinal study. From 2015 to 2018, when the women were aged 19-37 years, they were contacted by mail and phone, and interviewed about symptoms of pain. This included chronic widespread or regional symptoms of pain; widespread pain was pain that lasted more than 3 months and was described both above and below the waist, on both sides of the body, and in the axial skeleton. Any pain that lasted more than 3 months but did not meet those other requirements was listed as chronic regional pain.
Chronic pain of any kind was reported by 59 participants (76.6%). Chronic widespread pain was reported by 25 participants (32.5%), and chronic regional pain was reported by 34 (44.2%), both of which were higher than those seen in a cross-sectional survey, which showed prevalences of 11.9% and 23.9% of Swedish participants, respectively (J Rheumatol. 2001 Jun;28[6]:1369-77).
Among the limitations of the latest study is the small sample size and the absence of healthy controls; however, the researchers thought this was compensated for by the comparisons with previous research.
“ and possible unrecognized ASD and/or ADHD in women with chronic pain,” they concluded.
The investigators reported no conflicts of interest.
SOURCE: Asztély et al. J Pain Res. 2019 Oct 18;12:2925-32.
Women with ADHD, autism spectrum disorder (ASD), or both report higher rates of chronic pain, which should be accounted for in the treatment received, new research shows.
In some cases, treating the ADHD might lower the pain, reported Karin Asztély of the Sahlgrenska Academy Institute of Neuroscience, Göteborg, Sweden, and associates. The study was published in the Journal of Pain Research.
The research included 77 Swedish women with ADHD, ASD, or both from a larger prospective longitudinal study. From 2015 to 2018, when the women were aged 19-37 years, they were contacted by mail and phone, and interviewed about symptoms of pain. This included chronic widespread or regional symptoms of pain; widespread pain was pain that lasted more than 3 months and was described both above and below the waist, on both sides of the body, and in the axial skeleton. Any pain that lasted more than 3 months but did not meet those other requirements was listed as chronic regional pain.
Chronic pain of any kind was reported by 59 participants (76.6%). Chronic widespread pain was reported by 25 participants (32.5%), and chronic regional pain was reported by 34 (44.2%), both of which were higher than those seen in a cross-sectional survey, which showed prevalences of 11.9% and 23.9% of Swedish participants, respectively (J Rheumatol. 2001 Jun;28[6]:1369-77).
Among the limitations of the latest study is the small sample size and the absence of healthy controls; however, the researchers thought this was compensated for by the comparisons with previous research.
“ and possible unrecognized ASD and/or ADHD in women with chronic pain,” they concluded.
The investigators reported no conflicts of interest.
SOURCE: Asztély et al. J Pain Res. 2019 Oct 18;12:2925-32.
Women with ADHD, autism spectrum disorder (ASD), or both report higher rates of chronic pain, which should be accounted for in the treatment received, new research shows.
In some cases, treating the ADHD might lower the pain, reported Karin Asztély of the Sahlgrenska Academy Institute of Neuroscience, Göteborg, Sweden, and associates. The study was published in the Journal of Pain Research.
The research included 77 Swedish women with ADHD, ASD, or both from a larger prospective longitudinal study. From 2015 to 2018, when the women were aged 19-37 years, they were contacted by mail and phone, and interviewed about symptoms of pain. This included chronic widespread or regional symptoms of pain; widespread pain was pain that lasted more than 3 months and was described both above and below the waist, on both sides of the body, and in the axial skeleton. Any pain that lasted more than 3 months but did not meet those other requirements was listed as chronic regional pain.
Chronic pain of any kind was reported by 59 participants (76.6%). Chronic widespread pain was reported by 25 participants (32.5%), and chronic regional pain was reported by 34 (44.2%), both of which were higher than those seen in a cross-sectional survey, which showed prevalences of 11.9% and 23.9% of Swedish participants, respectively (J Rheumatol. 2001 Jun;28[6]:1369-77).
Among the limitations of the latest study is the small sample size and the absence of healthy controls; however, the researchers thought this was compensated for by the comparisons with previous research.
“ and possible unrecognized ASD and/or ADHD in women with chronic pain,” they concluded.
The investigators reported no conflicts of interest.
SOURCE: Asztély et al. J Pain Res. 2019 Oct 18;12:2925-32.
FROM THE JOURNAL OF PAIN RESEARCH
FDA still concerned about biotin affecting troponin tests
The
However, not all troponin tests are affected, according to the update. “Since the FDA’s safety communication on this topic in 2017, some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it,” according to the new communication, issued in early November.
Also known as vitamin B7 and appearing in many dietary supplements, including prenatal multivitamins and supplements for hair, skin, and nail growth, biotin can lead to falsely low results on some troponin tests, especially at high levels. The worry is that biotin interference could therefore lead to missed diagnoses. The FDA has provided a list of those tests that have not taken biotin’s effects into account, titled “Biotin Interference with Troponin Lab Tests – Assays Subject to Biotin Interference.”
The daily recommended allowance for biotin, according to the communication, is about 0.3 mg, but it isn’t always clear how much is actually included in supplements – some can contain 20 mg or even as much as 100 mg per pill of biotin. The communication includes recommendations for patients, health care professionals, laboratory personnel, and lab test manufacturers and developers.
The full safety communication can be found on the FDA website, and problems with tests can be reported via the FDA’s MedWatch Voluntary Reporting Form.
The
However, not all troponin tests are affected, according to the update. “Since the FDA’s safety communication on this topic in 2017, some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it,” according to the new communication, issued in early November.
Also known as vitamin B7 and appearing in many dietary supplements, including prenatal multivitamins and supplements for hair, skin, and nail growth, biotin can lead to falsely low results on some troponin tests, especially at high levels. The worry is that biotin interference could therefore lead to missed diagnoses. The FDA has provided a list of those tests that have not taken biotin’s effects into account, titled “Biotin Interference with Troponin Lab Tests – Assays Subject to Biotin Interference.”
The daily recommended allowance for biotin, according to the communication, is about 0.3 mg, but it isn’t always clear how much is actually included in supplements – some can contain 20 mg or even as much as 100 mg per pill of biotin. The communication includes recommendations for patients, health care professionals, laboratory personnel, and lab test manufacturers and developers.
The full safety communication can be found on the FDA website, and problems with tests can be reported via the FDA’s MedWatch Voluntary Reporting Form.
The
However, not all troponin tests are affected, according to the update. “Since the FDA’s safety communication on this topic in 2017, some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it,” according to the new communication, issued in early November.
Also known as vitamin B7 and appearing in many dietary supplements, including prenatal multivitamins and supplements for hair, skin, and nail growth, biotin can lead to falsely low results on some troponin tests, especially at high levels. The worry is that biotin interference could therefore lead to missed diagnoses. The FDA has provided a list of those tests that have not taken biotin’s effects into account, titled “Biotin Interference with Troponin Lab Tests – Assays Subject to Biotin Interference.”
The daily recommended allowance for biotin, according to the communication, is about 0.3 mg, but it isn’t always clear how much is actually included in supplements – some can contain 20 mg or even as much as 100 mg per pill of biotin. The communication includes recommendations for patients, health care professionals, laboratory personnel, and lab test manufacturers and developers.
The full safety communication can be found on the FDA website, and problems with tests can be reported via the FDA’s MedWatch Voluntary Reporting Form.
Resting-state cerebral blood flow tied to apathy in schizophrenia
Regional resting-state cerebral blood flow (rCBF) in the ventral and dorsal striatum is associated with apathy in patients with schizophrenia – but not with diminished expression, results of a small study suggest.
“This distinction is of high relevance when investigating striatal rCBF,” wrote Karoline Schneider, MD, and colleagues. “The paucity of reported associations beween striatal rCBF and negative symptoms could result from the fact that until now apathy and diminished expression have not been addressed separately.” The study was published in the Journal of Psychiatry & Neuroscience.
Dr. Schneider and colleagues used arterial spin labeling MRI to measure rCBF in 29 patients with schizophrenia from outpatient and inpatient units affiliated with the University of Zürich and in 20 controls without schizophrenia. Negative symptoms were assessed via the Brief Negative Symptom Scale and were divided into those of apathy or those of diminished expression.
, and between severity and higher rCBF in the left and right dorsal striatum (r = 0.48; P = .008). However, the correlations were nonsignificant for symptoms of diminished expression, reported Dr. Schneider, of the university’s department of psychiatry, psychotherapy, and psychosomatics.
“The association between increased striatal rCBF and the negative symptom dimension of apathy, but not diminished expression, provides further evidence for the assumption of different underlying neural bases,” Dr. Schneider and colleagues concluded. “These dimensions should be considered separately in future research on negative symptoms.”
Limitations of the study include its sample size. Another limitation is that all patients with schizophrenia in the study were taking second-generation antipsychotics, which in some research appears to influence striatal rCBF.
Grants from the Swiss National Science Foundation funded the study. Dr. Schneider reported no conflicts of interest. Two authors disclosed receiving grant support or honoraria from pharmaceutical companies but said those activities were unrelated to this study.
SOURCE: Schneider K et al. J Psychiatry Neurosci. 2019;44(2):102-10.
Regional resting-state cerebral blood flow (rCBF) in the ventral and dorsal striatum is associated with apathy in patients with schizophrenia – but not with diminished expression, results of a small study suggest.
“This distinction is of high relevance when investigating striatal rCBF,” wrote Karoline Schneider, MD, and colleagues. “The paucity of reported associations beween striatal rCBF and negative symptoms could result from the fact that until now apathy and diminished expression have not been addressed separately.” The study was published in the Journal of Psychiatry & Neuroscience.
Dr. Schneider and colleagues used arterial spin labeling MRI to measure rCBF in 29 patients with schizophrenia from outpatient and inpatient units affiliated with the University of Zürich and in 20 controls without schizophrenia. Negative symptoms were assessed via the Brief Negative Symptom Scale and were divided into those of apathy or those of diminished expression.
, and between severity and higher rCBF in the left and right dorsal striatum (r = 0.48; P = .008). However, the correlations were nonsignificant for symptoms of diminished expression, reported Dr. Schneider, of the university’s department of psychiatry, psychotherapy, and psychosomatics.
“The association between increased striatal rCBF and the negative symptom dimension of apathy, but not diminished expression, provides further evidence for the assumption of different underlying neural bases,” Dr. Schneider and colleagues concluded. “These dimensions should be considered separately in future research on negative symptoms.”
Limitations of the study include its sample size. Another limitation is that all patients with schizophrenia in the study were taking second-generation antipsychotics, which in some research appears to influence striatal rCBF.
Grants from the Swiss National Science Foundation funded the study. Dr. Schneider reported no conflicts of interest. Two authors disclosed receiving grant support or honoraria from pharmaceutical companies but said those activities were unrelated to this study.
SOURCE: Schneider K et al. J Psychiatry Neurosci. 2019;44(2):102-10.
Regional resting-state cerebral blood flow (rCBF) in the ventral and dorsal striatum is associated with apathy in patients with schizophrenia – but not with diminished expression, results of a small study suggest.
“This distinction is of high relevance when investigating striatal rCBF,” wrote Karoline Schneider, MD, and colleagues. “The paucity of reported associations beween striatal rCBF and negative symptoms could result from the fact that until now apathy and diminished expression have not been addressed separately.” The study was published in the Journal of Psychiatry & Neuroscience.
Dr. Schneider and colleagues used arterial spin labeling MRI to measure rCBF in 29 patients with schizophrenia from outpatient and inpatient units affiliated with the University of Zürich and in 20 controls without schizophrenia. Negative symptoms were assessed via the Brief Negative Symptom Scale and were divided into those of apathy or those of diminished expression.
, and between severity and higher rCBF in the left and right dorsal striatum (r = 0.48; P = .008). However, the correlations were nonsignificant for symptoms of diminished expression, reported Dr. Schneider, of the university’s department of psychiatry, psychotherapy, and psychosomatics.
“The association between increased striatal rCBF and the negative symptom dimension of apathy, but not diminished expression, provides further evidence for the assumption of different underlying neural bases,” Dr. Schneider and colleagues concluded. “These dimensions should be considered separately in future research on negative symptoms.”
Limitations of the study include its sample size. Another limitation is that all patients with schizophrenia in the study were taking second-generation antipsychotics, which in some research appears to influence striatal rCBF.
Grants from the Swiss National Science Foundation funded the study. Dr. Schneider reported no conflicts of interest. Two authors disclosed receiving grant support or honoraria from pharmaceutical companies but said those activities were unrelated to this study.
SOURCE: Schneider K et al. J Psychiatry Neurosci. 2019;44(2):102-10.
FROM THE JOURNAL OF PSYCHIATRY & NEUROSCIENCE
Emotional processing of scenes in bipolar I appears intact
New findings contradict previous studies on processing of faces in bipolar
Differences in self-reported and EEG-measured responses to emotional scenes between patients with bipolar I disorder with and without a history of psychosis, and healthy controls are negligible, results of a cross-sectional study suggest.
“While prior research supports abnormalities in the emotional face response, this study suggests these neural and behavior differences do not fully generalize to scenes, indicating that nonsocial emotional responding may be intact in these patients,” reported Rebekah L. Trotti and colleagues.
The investigators conducted a multisite study among 130 participants with bipolar and a history of psychosis, 75 with bipolar and no history of psychosis, and 181 healthy controls. Although the investigators had hypothesized that, in keeping with findings from face-processing studies, emotional responses would be reduced in patients with bipolar I disorder, The groups were presented with the same 60 scenes that were unpleasant, neutral, or pleasant. The study was published in the Journal of Psychiatric Research.
Participants rated each scene according to the Self-Assessment Manikin after the respective EEG readings were taken. No significant statistical differences were seen on these ratings between groups, reported Ms. Trotti, a graduate student in the behavioral and brain sciences program at the University of Georgia, Athens, and colleagues.
The investigators also assessed whether participants had psychosis and looked at medications they were taking. However, those analyses also showed no statistically significant differences between participants with bipolar I and a history of psychosis, those with bipolar and no history of psychosis, and healthy controls in the processing of emotional scenes. Ms. Trotti and colleagues noted that other ways of differentiating subtypes in this heterogeneous disorder, such as those based on biomarkers and brain structure rather than those laid out by the DSM, might yield the differences in neural activity they had expected.
“Future research on this topic should focus on neurocognitive subtypes of mood and psychotic disorders, as well as other domains of emotional responding and behavior,” Ms. Trotti and colleagues wrote.
SOURCE: Trotti RL et al. J Psychiatr Res. 2019. doi: 10.1016/j.jpsychires.2019.10.005.
New findings contradict previous studies on processing of faces in bipolar
New findings contradict previous studies on processing of faces in bipolar
Differences in self-reported and EEG-measured responses to emotional scenes between patients with bipolar I disorder with and without a history of psychosis, and healthy controls are negligible, results of a cross-sectional study suggest.
“While prior research supports abnormalities in the emotional face response, this study suggests these neural and behavior differences do not fully generalize to scenes, indicating that nonsocial emotional responding may be intact in these patients,” reported Rebekah L. Trotti and colleagues.
The investigators conducted a multisite study among 130 participants with bipolar and a history of psychosis, 75 with bipolar and no history of psychosis, and 181 healthy controls. Although the investigators had hypothesized that, in keeping with findings from face-processing studies, emotional responses would be reduced in patients with bipolar I disorder, The groups were presented with the same 60 scenes that were unpleasant, neutral, or pleasant. The study was published in the Journal of Psychiatric Research.
Participants rated each scene according to the Self-Assessment Manikin after the respective EEG readings were taken. No significant statistical differences were seen on these ratings between groups, reported Ms. Trotti, a graduate student in the behavioral and brain sciences program at the University of Georgia, Athens, and colleagues.
The investigators also assessed whether participants had psychosis and looked at medications they were taking. However, those analyses also showed no statistically significant differences between participants with bipolar I and a history of psychosis, those with bipolar and no history of psychosis, and healthy controls in the processing of emotional scenes. Ms. Trotti and colleagues noted that other ways of differentiating subtypes in this heterogeneous disorder, such as those based on biomarkers and brain structure rather than those laid out by the DSM, might yield the differences in neural activity they had expected.
“Future research on this topic should focus on neurocognitive subtypes of mood and psychotic disorders, as well as other domains of emotional responding and behavior,” Ms. Trotti and colleagues wrote.
SOURCE: Trotti RL et al. J Psychiatr Res. 2019. doi: 10.1016/j.jpsychires.2019.10.005.
Differences in self-reported and EEG-measured responses to emotional scenes between patients with bipolar I disorder with and without a history of psychosis, and healthy controls are negligible, results of a cross-sectional study suggest.
“While prior research supports abnormalities in the emotional face response, this study suggests these neural and behavior differences do not fully generalize to scenes, indicating that nonsocial emotional responding may be intact in these patients,” reported Rebekah L. Trotti and colleagues.
The investigators conducted a multisite study among 130 participants with bipolar and a history of psychosis, 75 with bipolar and no history of psychosis, and 181 healthy controls. Although the investigators had hypothesized that, in keeping with findings from face-processing studies, emotional responses would be reduced in patients with bipolar I disorder, The groups were presented with the same 60 scenes that were unpleasant, neutral, or pleasant. The study was published in the Journal of Psychiatric Research.
Participants rated each scene according to the Self-Assessment Manikin after the respective EEG readings were taken. No significant statistical differences were seen on these ratings between groups, reported Ms. Trotti, a graduate student in the behavioral and brain sciences program at the University of Georgia, Athens, and colleagues.
The investigators also assessed whether participants had psychosis and looked at medications they were taking. However, those analyses also showed no statistically significant differences between participants with bipolar I and a history of psychosis, those with bipolar and no history of psychosis, and healthy controls in the processing of emotional scenes. Ms. Trotti and colleagues noted that other ways of differentiating subtypes in this heterogeneous disorder, such as those based on biomarkers and brain structure rather than those laid out by the DSM, might yield the differences in neural activity they had expected.
“Future research on this topic should focus on neurocognitive subtypes of mood and psychotic disorders, as well as other domains of emotional responding and behavior,” Ms. Trotti and colleagues wrote.
SOURCE: Trotti RL et al. J Psychiatr Res. 2019. doi: 10.1016/j.jpsychires.2019.10.005.
FROM THE JOURNAL OF PSYCHIATRIC RESEARCH
Six strengths identified in adult men with ADHD
A qualitative investigation based on interviews with successful adults with ADHD identified six core themes that are positive aspects of ADHD.
Under a phenomenology framework, purposive sampling was used to enroll six successful male participants with ADHD diagnoses. The participants were interviewed in an open-ended way and were assessed with theme content analysis, reported Jane Ann Sedgwick, a PhD candidate within the MRC Social, Genetic & Developmental Psychiatry Center at King’s College London, and coauthors. The six core themes identified were cognitive dynamism, courage, energy, humanity, resilience, and transcendence. They then compared those themes with attributes cataloged in a handbook by Christopher Petersen and Marten E.P. Seligman (Character Strengths and Virtues: A Handbook and Classification. Washington: American Psychological Association and Oxford University Press, 2004). The study was published in ADHD: Attention Deficit and Hyperactivity Disorders.
Because energy and cognitive dynamism as discussed in the present research were not cataloged in that handbook, they were unique to ADHD, according to Ms. Sedgwick and coauthors. The theme of energy described “participants’ reports about internal experiences and capacity for action,” with subthemes of spirit, which embraces higher aspects of self, sense of purpose, and meaning in life; psychological energy, including drive and volition; and physical energy, which can manifest as interest in and enjoyment of activities such as sports. Meanwhile, cognitive dynamism describes the “ceaseless mental activity that was reported by all participants,” including subthemes of divergent thinking, hyperfocus, creativity, and curiosity.
Limitations of the study included the shortcomings within the phenomenological framework, which requires participants who are capable of being articulate, expressive, and reflective. Another is the small sample size and absence of female participants.
“Too often people with lived experience hear about ADHD in relation to deficits, functional impairments, and associations with substance misuse, criminality, or other disadvantages on almost every level of life (school, work, relationships),” Ms. Sedgwick and her coauthors wrote.
A qualitative investigation based on interviews with successful adults with ADHD identified six core themes that are positive aspects of ADHD.
Under a phenomenology framework, purposive sampling was used to enroll six successful male participants with ADHD diagnoses. The participants were interviewed in an open-ended way and were assessed with theme content analysis, reported Jane Ann Sedgwick, a PhD candidate within the MRC Social, Genetic & Developmental Psychiatry Center at King’s College London, and coauthors. The six core themes identified were cognitive dynamism, courage, energy, humanity, resilience, and transcendence. They then compared those themes with attributes cataloged in a handbook by Christopher Petersen and Marten E.P. Seligman (Character Strengths and Virtues: A Handbook and Classification. Washington: American Psychological Association and Oxford University Press, 2004). The study was published in ADHD: Attention Deficit and Hyperactivity Disorders.
Because energy and cognitive dynamism as discussed in the present research were not cataloged in that handbook, they were unique to ADHD, according to Ms. Sedgwick and coauthors. The theme of energy described “participants’ reports about internal experiences and capacity for action,” with subthemes of spirit, which embraces higher aspects of self, sense of purpose, and meaning in life; psychological energy, including drive and volition; and physical energy, which can manifest as interest in and enjoyment of activities such as sports. Meanwhile, cognitive dynamism describes the “ceaseless mental activity that was reported by all participants,” including subthemes of divergent thinking, hyperfocus, creativity, and curiosity.
Limitations of the study included the shortcomings within the phenomenological framework, which requires participants who are capable of being articulate, expressive, and reflective. Another is the small sample size and absence of female participants.
“Too often people with lived experience hear about ADHD in relation to deficits, functional impairments, and associations with substance misuse, criminality, or other disadvantages on almost every level of life (school, work, relationships),” Ms. Sedgwick and her coauthors wrote.
A qualitative investigation based on interviews with successful adults with ADHD identified six core themes that are positive aspects of ADHD.
Under a phenomenology framework, purposive sampling was used to enroll six successful male participants with ADHD diagnoses. The participants were interviewed in an open-ended way and were assessed with theme content analysis, reported Jane Ann Sedgwick, a PhD candidate within the MRC Social, Genetic & Developmental Psychiatry Center at King’s College London, and coauthors. The six core themes identified were cognitive dynamism, courage, energy, humanity, resilience, and transcendence. They then compared those themes with attributes cataloged in a handbook by Christopher Petersen and Marten E.P. Seligman (Character Strengths and Virtues: A Handbook and Classification. Washington: American Psychological Association and Oxford University Press, 2004). The study was published in ADHD: Attention Deficit and Hyperactivity Disorders.
Because energy and cognitive dynamism as discussed in the present research were not cataloged in that handbook, they were unique to ADHD, according to Ms. Sedgwick and coauthors. The theme of energy described “participants’ reports about internal experiences and capacity for action,” with subthemes of spirit, which embraces higher aspects of self, sense of purpose, and meaning in life; psychological energy, including drive and volition; and physical energy, which can manifest as interest in and enjoyment of activities such as sports. Meanwhile, cognitive dynamism describes the “ceaseless mental activity that was reported by all participants,” including subthemes of divergent thinking, hyperfocus, creativity, and curiosity.
Limitations of the study included the shortcomings within the phenomenological framework, which requires participants who are capable of being articulate, expressive, and reflective. Another is the small sample size and absence of female participants.
“Too often people with lived experience hear about ADHD in relation to deficits, functional impairments, and associations with substance misuse, criminality, or other disadvantages on almost every level of life (school, work, relationships),” Ms. Sedgwick and her coauthors wrote.
FROM ADHD: ATTENTION DEFICIT AND HYPERACTIVITY DISORDERS
Religious vaccination exemptions may be personal belief exemptions in disguise
and they appear to go up when personal belief exemptions go away, which might be caused by a replacement effect, researchers hypothesized in Pediatrics.
“Put differently, state-level religious exemption rates appear to be a function of personal belief exemption availability, decreasing significantly when states offer a personal belief exemption alternative,” the researchers explained.
Led by Joshua T.B. Williams, MD, of the department of pediatrics at the Denver Health Medical Center, the researchers sought to update state-level analyses of vaccination exemption rates by performing a cross-sectional, retrospective investigation of publicly available aggregated yearly vaccine reports for kindergartners from the Centers for Disease Control and Prevention. They were specifically interested in the school years of 2011-2012 through 2017-2018 “to extend and provide meaningful comparisons to a previous study of exemption data” that had ended its study period in 2015-2016 (Open Forum Infect Dis. 2017 Nov 15. doi: 10.1093/ofid/ofx244). The researchers adjusted for heterogeneous exemption processes by coding for “difficulty” of obtaining such exemptions in accordance with that previous study’s methods because studies have suggested that nonmedical exemption rates are lower in states with more difficult exemption policies. They also looked at how rates of religious exemptions changed in Vermont after the state eliminated personal, or philosophical, exemptions in 2016. The final analysis included 295 state-years from among the 45 states and the District of Columbia that all allow religious exemptions and the 15 states that permit personal belief exemptions.
The unadjusted analysis showed that the mean proportion of kindergartners with religious exemptions was lower where personal belief exemptions were available (0.41%; 95% confidence interval, 0.28%-0.53%) than they were where only religious exemptions were an option (1.63%; 95% CI, 1.30%-1.97%). In the adjusted analysis, states with both religious and personal belief exemptions were only a quarter as likely to have kindergartners with religious exemptions than those without personal belief exemptions (adjusted risk ratio, 0.25; 95% CI, 0.16-0.38). Furthermore, the proportion of kindergartners in Vermont with religious exemptions went from 0.5% in the years 2011-2012 through 2015-2016 when personal belief exemptions were still an option, to 3.7% in 2016-2017 through 2017-2018, after they went away.
One of the study’s limitations is that not all states used the same methods of data collection; however, the authors felt that, given about three-quarters of states included performed censuses with at least 80% of children counted, the effects on the study’s results should be minimal.
After discussing the role of religious exemptions and some of their history, as well as citing the seemingly paradoxical reported decline in religiosity and rise in religious exemptions, the researchers wrote in their conclusion that these “may be an increasingly problematic or outdated exemption category, and researchers and policy makers must work together to determine how best to balance a respect for religious liberty and the need to protect public health.”
SOURCE: Williams JTB et al. Pediatrics. 2019 Nov. doi: 10.1542/peds.2019-2710.
and they appear to go up when personal belief exemptions go away, which might be caused by a replacement effect, researchers hypothesized in Pediatrics.
“Put differently, state-level religious exemption rates appear to be a function of personal belief exemption availability, decreasing significantly when states offer a personal belief exemption alternative,” the researchers explained.
Led by Joshua T.B. Williams, MD, of the department of pediatrics at the Denver Health Medical Center, the researchers sought to update state-level analyses of vaccination exemption rates by performing a cross-sectional, retrospective investigation of publicly available aggregated yearly vaccine reports for kindergartners from the Centers for Disease Control and Prevention. They were specifically interested in the school years of 2011-2012 through 2017-2018 “to extend and provide meaningful comparisons to a previous study of exemption data” that had ended its study period in 2015-2016 (Open Forum Infect Dis. 2017 Nov 15. doi: 10.1093/ofid/ofx244). The researchers adjusted for heterogeneous exemption processes by coding for “difficulty” of obtaining such exemptions in accordance with that previous study’s methods because studies have suggested that nonmedical exemption rates are lower in states with more difficult exemption policies. They also looked at how rates of religious exemptions changed in Vermont after the state eliminated personal, or philosophical, exemptions in 2016. The final analysis included 295 state-years from among the 45 states and the District of Columbia that all allow religious exemptions and the 15 states that permit personal belief exemptions.
The unadjusted analysis showed that the mean proportion of kindergartners with religious exemptions was lower where personal belief exemptions were available (0.41%; 95% confidence interval, 0.28%-0.53%) than they were where only religious exemptions were an option (1.63%; 95% CI, 1.30%-1.97%). In the adjusted analysis, states with both religious and personal belief exemptions were only a quarter as likely to have kindergartners with religious exemptions than those without personal belief exemptions (adjusted risk ratio, 0.25; 95% CI, 0.16-0.38). Furthermore, the proportion of kindergartners in Vermont with religious exemptions went from 0.5% in the years 2011-2012 through 2015-2016 when personal belief exemptions were still an option, to 3.7% in 2016-2017 through 2017-2018, after they went away.
One of the study’s limitations is that not all states used the same methods of data collection; however, the authors felt that, given about three-quarters of states included performed censuses with at least 80% of children counted, the effects on the study’s results should be minimal.
After discussing the role of religious exemptions and some of their history, as well as citing the seemingly paradoxical reported decline in religiosity and rise in religious exemptions, the researchers wrote in their conclusion that these “may be an increasingly problematic or outdated exemption category, and researchers and policy makers must work together to determine how best to balance a respect for religious liberty and the need to protect public health.”
SOURCE: Williams JTB et al. Pediatrics. 2019 Nov. doi: 10.1542/peds.2019-2710.
and they appear to go up when personal belief exemptions go away, which might be caused by a replacement effect, researchers hypothesized in Pediatrics.
“Put differently, state-level religious exemption rates appear to be a function of personal belief exemption availability, decreasing significantly when states offer a personal belief exemption alternative,” the researchers explained.
Led by Joshua T.B. Williams, MD, of the department of pediatrics at the Denver Health Medical Center, the researchers sought to update state-level analyses of vaccination exemption rates by performing a cross-sectional, retrospective investigation of publicly available aggregated yearly vaccine reports for kindergartners from the Centers for Disease Control and Prevention. They were specifically interested in the school years of 2011-2012 through 2017-2018 “to extend and provide meaningful comparisons to a previous study of exemption data” that had ended its study period in 2015-2016 (Open Forum Infect Dis. 2017 Nov 15. doi: 10.1093/ofid/ofx244). The researchers adjusted for heterogeneous exemption processes by coding for “difficulty” of obtaining such exemptions in accordance with that previous study’s methods because studies have suggested that nonmedical exemption rates are lower in states with more difficult exemption policies. They also looked at how rates of religious exemptions changed in Vermont after the state eliminated personal, or philosophical, exemptions in 2016. The final analysis included 295 state-years from among the 45 states and the District of Columbia that all allow religious exemptions and the 15 states that permit personal belief exemptions.
The unadjusted analysis showed that the mean proportion of kindergartners with religious exemptions was lower where personal belief exemptions were available (0.41%; 95% confidence interval, 0.28%-0.53%) than they were where only religious exemptions were an option (1.63%; 95% CI, 1.30%-1.97%). In the adjusted analysis, states with both religious and personal belief exemptions were only a quarter as likely to have kindergartners with religious exemptions than those without personal belief exemptions (adjusted risk ratio, 0.25; 95% CI, 0.16-0.38). Furthermore, the proportion of kindergartners in Vermont with religious exemptions went from 0.5% in the years 2011-2012 through 2015-2016 when personal belief exemptions were still an option, to 3.7% in 2016-2017 through 2017-2018, after they went away.
One of the study’s limitations is that not all states used the same methods of data collection; however, the authors felt that, given about three-quarters of states included performed censuses with at least 80% of children counted, the effects on the study’s results should be minimal.
After discussing the role of religious exemptions and some of their history, as well as citing the seemingly paradoxical reported decline in religiosity and rise in religious exemptions, the researchers wrote in their conclusion that these “may be an increasingly problematic or outdated exemption category, and researchers and policy makers must work together to determine how best to balance a respect for religious liberty and the need to protect public health.”
SOURCE: Williams JTB et al. Pediatrics. 2019 Nov. doi: 10.1542/peds.2019-2710.
FROM PEDIATRICS
COGS update shows viability of endophenotypes in schizophrenia research
Lead author Tiffany A. Greenwood, PhD, noted that clinically diverse schizophrenia patients often are grouped together to get large sample sizes for genome-wide association studies, which can miss specific features of the heterogeneous disorder. Instead, in phase 2 of the Consortium on the Genetics of Schizophrenia (COGS) study, Dr. Greenwood and associates sought to connect features clustered into endophenotypes with certain genetic regions of interest.
“As stable biomarkers of the underlying brain dysfunctions, endophenotypes hold promise for parsing clinical heterogeneity of schizophrenia and refining the genetic signal,” they wrote. The study was published in JAMA Psychiatry.
Using this approach among 1,533 participants, they found seven regions exceeding the conventional genome-wide association significance of P less than 5 x 10–8, including regions associated with the endophenotypes of face memory (chromosome 3p21; effect size, –0.72; P = 4.2 x 10–8), antisaccade task (chromosome 9q31; effect size, –0.24; P = 3.5 x 10–8), and abstraction and mental flexibility (chromosome 10q23; effect size, –0.56; P = 1.5 x 10–8).
Those endophenotypes and genes intersect theoretical molecular and biological processes that have been identified in other research and could explain underlying mechanisms of schizophrenia. For example, research has suggested that NRG3, which is near the region associated with abstraction and mental flexibility, and affects certain cellular signaling pathways, could be a locus of susceptibility; in particular, some variants of NRG3 have been associated with cognitive and psychotic symptom severity in previous research.
“Although shared genetic substrates appear likely, this is not a study of schizophrenia but rather a study of neurophysiological and neurocognitive deficits that occur in the general population but are more pronounced in the context of schizophrenia and have implications for treatment,” wrote Dr. Greenwood, of the University of California, San Diego, and associates.
One limitation of the study is that, as investigators have demonstrated elsewhere, P values can prove highly variable over the course of replication studies, so the significance thresholds shown in this study still could run the risk of hiding false positives or negatives.
“As many of the 11 endophenotypes have been endorsed as targets for the development of novel treatments for schizophrenia, a better understanding of the corresponding cellular and molecular processes may pave the way for precision-based medicine in schizophrenia and perhaps other psychiatric illnesses with a shared genetic liability,” Dr. Greenwood and associates concluded.
SOURCE: Greenwood TA et al. JAMA Psychiatry. 2019 Oct 9. doi: 10.1001/jamapsychiatry.2019.2850.
Lead author Tiffany A. Greenwood, PhD, noted that clinically diverse schizophrenia patients often are grouped together to get large sample sizes for genome-wide association studies, which can miss specific features of the heterogeneous disorder. Instead, in phase 2 of the Consortium on the Genetics of Schizophrenia (COGS) study, Dr. Greenwood and associates sought to connect features clustered into endophenotypes with certain genetic regions of interest.
“As stable biomarkers of the underlying brain dysfunctions, endophenotypes hold promise for parsing clinical heterogeneity of schizophrenia and refining the genetic signal,” they wrote. The study was published in JAMA Psychiatry.
Using this approach among 1,533 participants, they found seven regions exceeding the conventional genome-wide association significance of P less than 5 x 10–8, including regions associated with the endophenotypes of face memory (chromosome 3p21; effect size, –0.72; P = 4.2 x 10–8), antisaccade task (chromosome 9q31; effect size, –0.24; P = 3.5 x 10–8), and abstraction and mental flexibility (chromosome 10q23; effect size, –0.56; P = 1.5 x 10–8).
Those endophenotypes and genes intersect theoretical molecular and biological processes that have been identified in other research and could explain underlying mechanisms of schizophrenia. For example, research has suggested that NRG3, which is near the region associated with abstraction and mental flexibility, and affects certain cellular signaling pathways, could be a locus of susceptibility; in particular, some variants of NRG3 have been associated with cognitive and psychotic symptom severity in previous research.
“Although shared genetic substrates appear likely, this is not a study of schizophrenia but rather a study of neurophysiological and neurocognitive deficits that occur in the general population but are more pronounced in the context of schizophrenia and have implications for treatment,” wrote Dr. Greenwood, of the University of California, San Diego, and associates.
One limitation of the study is that, as investigators have demonstrated elsewhere, P values can prove highly variable over the course of replication studies, so the significance thresholds shown in this study still could run the risk of hiding false positives or negatives.
“As many of the 11 endophenotypes have been endorsed as targets for the development of novel treatments for schizophrenia, a better understanding of the corresponding cellular and molecular processes may pave the way for precision-based medicine in schizophrenia and perhaps other psychiatric illnesses with a shared genetic liability,” Dr. Greenwood and associates concluded.
SOURCE: Greenwood TA et al. JAMA Psychiatry. 2019 Oct 9. doi: 10.1001/jamapsychiatry.2019.2850.
Lead author Tiffany A. Greenwood, PhD, noted that clinically diverse schizophrenia patients often are grouped together to get large sample sizes for genome-wide association studies, which can miss specific features of the heterogeneous disorder. Instead, in phase 2 of the Consortium on the Genetics of Schizophrenia (COGS) study, Dr. Greenwood and associates sought to connect features clustered into endophenotypes with certain genetic regions of interest.
“As stable biomarkers of the underlying brain dysfunctions, endophenotypes hold promise for parsing clinical heterogeneity of schizophrenia and refining the genetic signal,” they wrote. The study was published in JAMA Psychiatry.
Using this approach among 1,533 participants, they found seven regions exceeding the conventional genome-wide association significance of P less than 5 x 10–8, including regions associated with the endophenotypes of face memory (chromosome 3p21; effect size, –0.72; P = 4.2 x 10–8), antisaccade task (chromosome 9q31; effect size, –0.24; P = 3.5 x 10–8), and abstraction and mental flexibility (chromosome 10q23; effect size, –0.56; P = 1.5 x 10–8).
Those endophenotypes and genes intersect theoretical molecular and biological processes that have been identified in other research and could explain underlying mechanisms of schizophrenia. For example, research has suggested that NRG3, which is near the region associated with abstraction and mental flexibility, and affects certain cellular signaling pathways, could be a locus of susceptibility; in particular, some variants of NRG3 have been associated with cognitive and psychotic symptom severity in previous research.
“Although shared genetic substrates appear likely, this is not a study of schizophrenia but rather a study of neurophysiological and neurocognitive deficits that occur in the general population but are more pronounced in the context of schizophrenia and have implications for treatment,” wrote Dr. Greenwood, of the University of California, San Diego, and associates.
One limitation of the study is that, as investigators have demonstrated elsewhere, P values can prove highly variable over the course of replication studies, so the significance thresholds shown in this study still could run the risk of hiding false positives or negatives.
“As many of the 11 endophenotypes have been endorsed as targets for the development of novel treatments for schizophrenia, a better understanding of the corresponding cellular and molecular processes may pave the way for precision-based medicine in schizophrenia and perhaps other psychiatric illnesses with a shared genetic liability,” Dr. Greenwood and associates concluded.
SOURCE: Greenwood TA et al. JAMA Psychiatry. 2019 Oct 9. doi: 10.1001/jamapsychiatry.2019.2850.
FROM JAMA PSYCHIATRY
FDA approves onabotulinumtoxinA for pediatric lower limb spasticity
The Food and Drug Administration has approved onabotulinumtoxinA (Botox) for treatment of pediatric lower limb spasticity in patients aged 2-17 years, excluding those in whom it is associated with cerebral palsy, according to an announcement from Allergan.
The approval is based on a phase 3 study evaluating safety and efficacy in more than 300 patients with lower limb spasticity. Although patients with cerebral palsy were included in the study, they’re excluded from this indication. Orphan Drug Exclusivity prevents it from being indicated for lower limb spasticity in cerebral palsy because abobotulinumtoxinA (Dysport) already has marketing exclusivity for the indication. Botox also is indicated for children aged 2-17 years of age with upper limb spasticity, as well as nine other indications.
OnabotulinumtoxinA comes with warnings, including problems of swallowing, speaking, or breathing and even risk of spread of the toxin. It also may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours or weeks of administration. Serious and sometimes immediate allergic reactions have been reported. Patients and health care professionals should discuss various concerns before treatment, including whether the patient has recently received antibiotics by injection, or has taken muscle relaxants, allergy or cold medicine, sleep medicine, and aspirinlike products or blood thinners. It’s important to note that the dose of onabotulinumtoxinA is not the same as that for other botulinum toxin products. The full prescribing information is available on the Allergan website.
The Food and Drug Administration has approved onabotulinumtoxinA (Botox) for treatment of pediatric lower limb spasticity in patients aged 2-17 years, excluding those in whom it is associated with cerebral palsy, according to an announcement from Allergan.
The approval is based on a phase 3 study evaluating safety and efficacy in more than 300 patients with lower limb spasticity. Although patients with cerebral palsy were included in the study, they’re excluded from this indication. Orphan Drug Exclusivity prevents it from being indicated for lower limb spasticity in cerebral palsy because abobotulinumtoxinA (Dysport) already has marketing exclusivity for the indication. Botox also is indicated for children aged 2-17 years of age with upper limb spasticity, as well as nine other indications.
OnabotulinumtoxinA comes with warnings, including problems of swallowing, speaking, or breathing and even risk of spread of the toxin. It also may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours or weeks of administration. Serious and sometimes immediate allergic reactions have been reported. Patients and health care professionals should discuss various concerns before treatment, including whether the patient has recently received antibiotics by injection, or has taken muscle relaxants, allergy or cold medicine, sleep medicine, and aspirinlike products or blood thinners. It’s important to note that the dose of onabotulinumtoxinA is not the same as that for other botulinum toxin products. The full prescribing information is available on the Allergan website.
The Food and Drug Administration has approved onabotulinumtoxinA (Botox) for treatment of pediatric lower limb spasticity in patients aged 2-17 years, excluding those in whom it is associated with cerebral palsy, according to an announcement from Allergan.
The approval is based on a phase 3 study evaluating safety and efficacy in more than 300 patients with lower limb spasticity. Although patients with cerebral palsy were included in the study, they’re excluded from this indication. Orphan Drug Exclusivity prevents it from being indicated for lower limb spasticity in cerebral palsy because abobotulinumtoxinA (Dysport) already has marketing exclusivity for the indication. Botox also is indicated for children aged 2-17 years of age with upper limb spasticity, as well as nine other indications.
OnabotulinumtoxinA comes with warnings, including problems of swallowing, speaking, or breathing and even risk of spread of the toxin. It also may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours or weeks of administration. Serious and sometimes immediate allergic reactions have been reported. Patients and health care professionals should discuss various concerns before treatment, including whether the patient has recently received antibiotics by injection, or has taken muscle relaxants, allergy or cold medicine, sleep medicine, and aspirinlike products or blood thinners. It’s important to note that the dose of onabotulinumtoxinA is not the same as that for other botulinum toxin products. The full prescribing information is available on the Allergan website.