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Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children
A recent study published in American Journal of Psychiatry suggests there may be a link between the use of stimulant medications for attention-deficit hyperactivity disorder (also known as ADHD) and sudden cardiac death in healthy children. In the study, the investigators compared the use of stimulant medications in two groups of children in the United States: one group of 564 healthy children who died suddenly from unexplained heart related problems and one group of 564 children who died as passengers in a motor vehicle accident. According to the study report, 10 of the healthy children who died suddenly from unexplained heart problems, or 1.8% of the group, were reported to be taking a stimulant medication at the time of death. This compared with only two cases of stimulant use, or 0.4%, among healthy children who had died in motor vehicle accidents. At this time, the FDA is reviewing the results of the study and is unable to conclude that the results of the study affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. The FDA says that, because of the study's limitations, parents should not stop a child's stimulant medication based on the study. Prescription stimulant medications are used to treat ADHD, a continuous pattern of inattention and/or hyperactivity-impulsiveness that is more severe than expected for a child's developmental age. Examples of stimulant treatments for ADHD include: dexmethylphenidate (Focalin, Focalin XR), dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR), mixed salts amphetamine (Adderall, Adderall XR), pemoline (Cylert), and generics. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166667.htm
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Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children
A recent study published in American Journal of Psychiatry suggests there may be a link between the use of stimulant medications for attention-deficit hyperactivity disorder (also known as ADHD) and sudden cardiac death in healthy children. In the study, the investigators compared the use of stimulant medications in two groups of children in the United States: one group of 564 healthy children who died suddenly from unexplained heart related problems and one group of 564 children who died as passengers in a motor vehicle accident. According to the study report, 10 of the healthy children who died suddenly from unexplained heart problems, or 1.8% of the group, were reported to be taking a stimulant medication at the time of death. This compared with only two cases of stimulant use, or 0.4%, among healthy children who had died in motor vehicle accidents. At this time, the FDA is reviewing the results of the study and is unable to conclude that the results of the study affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. The FDA says that, because of the study's limitations, parents should not stop a child's stimulant medication based on the study. Prescription stimulant medications are used to treat ADHD, a continuous pattern of inattention and/or hyperactivity-impulsiveness that is more severe than expected for a child's developmental age. Examples of stimulant treatments for ADHD include: dexmethylphenidate (Focalin, Focalin XR), dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR), mixed salts amphetamine (Adderall, Adderall XR), pemoline (Cylert), and generics. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166667.htm
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Date Published Title Drug Source
2009-06-16 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Methylphenidate FDA
2009-06-16 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Amphetamine Salts FDA
2009-06-16 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Cylert FDA
2009-06-16 Warnings on Three Zicam Intranasal Zinc Products Zicam FDA
2009-06-16 Warnings on Three Zicam Intranasal Zinc Products Zinc FDA
2009-06-15 Select Lots of Levemir Insulin (Insulin Detemir [rDNA origin] Injection) Reported Stolen Insulin Detemir FDA
2009-06-15 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Dexmethylphenidate FDA
2009-06-15 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Dextroamphetamine FDA
2009-06-15 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Lisdexamfetamine FDA
2009-06-12 Updated Safety Information from FDA Safety Review Montelukast FDA
2009-06-12 Updated Safety Information from FDA Safety Review Zafirlukast FDA
2009-06-12 Updated Safety Information from FDA Safety Review Zileuton FDA
2009-06-11 New Safety Information About the Use of Sirolimus (Rapamune) in LIVER Transplant Patients Sirolimus FDA
2009-06-08 Thiazolidinediones Associated with Increased Risk of Fractures Pioglitazone MediGuard CRT
2009-06-08 Thiazolidinediones Associated with Increased Risk of Fractures Rosiglitazone MediGuard CRT
2009-06-08 Thiazolidinediones Associated with Increased Risk of Fractures Metformin with Rosiglitazone MediGuard CRT
2009-06-08 Thiazolidinediones Associated with Increased Risk of Fractures Pioglitazone and Metformin MediGuard CRT
2009-06-08 Thiazolidinediones Associated with Increased Risk of Fractures MediGuard CRT
2009-06-08 Thiazolidinediones Associated with Increased Risk of Fractures Glimepiride and Pioglitazone MediGuard CRT
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Chlorpromazine MediGuard CRT