FDA may expand warning for antidepressants

Federal health officials unveiled proposed changes to the labeling of antidepressant drugs. Officials said that treatment with the drugs increases the risk of suicidal thoughts and behaviors in patients 24 and younger.

The proposed changes would expand a warning already present on the labels that applies only to children and adolescents treated with the drugs for anxiety, depression, ADHD and related disorders.

The FDA announced its plan to update the drug labels early today at the beginning of a meeting of outside advisers convened to discuss the proposal. The changes would also include a recommendation that patients of all ages be closely monitored, especially when beginning treatment with antidepressants.

Mental health experts are expressing concerns that additional warnings about suicide risks could curb the use of antidepressants and ultimately do more harm than good.

The proposed changes come after an FDA review that found using antidepressants may increase the risk of suicidal thoughts and behavior in men and women ages 18 to 24.

But, by adding the “black box” or other warnings to the labeling, doctors, parents, and patients may be scared away from using them, according to cautious health experts. They warn that people with untreated depression – which is said to make up about half of all those who suffer from the disease – face an estimated 15% greater likelihood of suicide.

Dr. Carolyn Robinowitz, president-elect of the American Psychiatric Association, said she is concerned that “by not simply promoting good standards of care and by putting on a black-box label, the FDA may unwittingly limit further access to care.”

However, antidepressant-use continues to grow, with nearly 190 million prescriptions dispensed in the US last year, according to IMS Health, a healthcare information company. These numbers suggest that doctors have placed more weight on the long-term benefits of the drugs than on short-term risks, according to Dr. Thomas Laughren, director of the FDA’s division of psychiatry products.

The FDA recently completed a mass review of 372 studies involving around 100,000 patients and 11 antidepressant drugs, including Zoloft, Paxil, Lexapro and Prozac. When the results were analyzed by age, it became clear that there is an elevated but short-term risk for suicidal thoughts and behavior among adults 18 to 24 that approaches that seen in children, according to documents released by the FDA prior to Wednesday’s meeting of its psychopharmacologic drugs advisory committee.

The analysis of the studies suggests an age-related shift in suicidality risk associated with treatment with the drugs. For example, antidepressants seem to protect against suicidal thoughts and behavior in men and women over 30, with the most pronounced effect in those 65 and over.

SOURCES: Robinowitz C, American Psychiatric Association. IMS Health. Laughren T, Food & Drug Administration, Division of Psychiatry Products.

© Copyright 2007 Insight Journal Online Magazine.

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