Magazine article Developments in Mental Health Law

FDA Publicizes Steps Taken to Warn of Risks Associated with Pair of Drugs Used to Treat Psychiatric Disorders

Magazine article Developments in Mental Health Law

FDA Publicizes Steps Taken to Warn of Risks Associated with Pair of Drugs Used to Treat Psychiatric Disorders

Article excerpt

On September 27, 2005, the Food and Drug Administration (FDA) posted on its Web site a warning that the popular antidepressant Paxil may increase the risk of birth defects if pregnant women take it during the first trimester. The FDA acted after the manufacturer of the drug, GlaxoSmithKline, sent the agency a letter citing evidence from a new study and stating that it had changed the drug's label to reflect the possibility of the risk. The study involved 3,581 pregnant women and found a 4% incidence of birth defects in those taking Paxil during the first trimester, versus a 2% incidence in those taking other antidepressants, with the most common malformation being ventricular septal defects (i.e., holes or other flaws in the wall between two of the heart's chambers). The company reported that the risk in the general population is 3%. Benedict Carey, Paxil Alert for Pregnant Women, N.Y. TIMES (Sept. 29, 2005).

On September 29, the FDA warned that Strattera, a drug commonly prescribed for attention deficit hyperactivity disorder (ADHD) as an alternative to stimulants may increase suicidal thinking in children and adolescents. The warning stemmed from a large-scale government study to examine whether psychiatric drugs have previously unrecognized side effects. …

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