Sixteen months after 7-year-old Gabriel Myers committed suicide while taking psychotropic drugs, the state of Florida has banned allowing any children in the state’s custody from participating in clinical drug trials.
Ken Kramer, a researcher with the Citizens Commission on Human Rights of Florida, says the numbers underestimate the extent of the problem, because medical examiners do not track deaths attributed to antipsychotic drugs or to antidepressants, both of which carry black-box or black-label warnings. The warnings on antidepressants, required by the Food and Drug Administration, state that the drugs increase the risk of suicidal thinking and behavior in children, adolescents and young adults up to age 24. (Antidepressants include Paxil, Prozac, Zoloft, Effexor, Lexapro and Celexa.)
The heightened risk of teen suicide doesn’t vary among users of different antidepressants, a new study finds. Researchers say the finding supports the FDA’s current “black box” warning on all antidepressants detailing the increased risk of suicide attempts and suicides in children and teens who start to take the drugs. A “black box” warning is the FDA’s most severe warning label.
The FDA announced that Norpramin (desipramine), an antidepressant made by Sanofi Aventis can cause disturbances in the heartbeat, including sudden cardiac death in people who have a family history of this or other heart rhythm disturbances. MedWatch, the safety information arm of the FDA and the manufacturer sent this new warning to healthcare professionals.