Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has issued a Safety Communication about an ongoing review of stimulant medication used in children with attention-deficit hyperactivity disorder (ADHD) because of reports of sudden cardiac death in healthy children. The events are part of a study published in the American Journal of Psychiatry. Because of the study’s limitations, the FDA urges parents not to stop a child’s stimulant medication based on the study and to discuss concerns about the use of these medications with the health care professional who prescribed the medications.

The study, which is funded by the FDA and the National Institute of Mental Health, compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly, to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. The study’s authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children.

The FDA cannot conclude at this time that data in the study affect the overall risk-benefit profile of stimulant medications used to treat ADHD in children. The study’s limitations include a significant lag time between dates when the deaths occurred and collection of the data; the difference in circumstances of death varied between family or caregiver; sudden, unexplained death in a child would be more likely to trigger a post-mortem inquiry into the cause of death than death due to blunt force trauma as a result of a motor vehicle collision; and there was a low frequency of stimulant use reported in both the study group and the control group.

The FDA advises that any child who develops cardiovascular symptoms such as chest pain, shortness of breath or fainting during stimulant medication treatment should immediately be seen by a doctor.

The FDA is continuing to review the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used ADHD in children. The FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential for risks associated with stimulant medication use in children. That data is expected to be completed in late 2009.

This entry was posted on Monday, June 15th, 2009 at 1:46 pm and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.