Wall Street Journal (10.15.04)

FDA Strengthens Warning Labels On Antidepressants.

     By Jennifer Corbett Dooren
 

WASHINGTON -- All antidepressants must carry a strong "black box" label warning that the drugs increase the risk of suicidal thoughts and behaviors in children and adolescents taking the medications, the Food and Drug Administration announced Friday.

The agency also will require a medication guide, written for patients, to be distributed with each prescription and each refill of the medications for both children and adults.

The medications also will be required to be packaged in a premeasured, sealed package. Pharmacists no longer will be able to obtain the drugs in bulk and then dispense them in smaller bottles.

The changes will be effective immediately. The labels will apply to all drugs, even though only Eli Lilly & Co.'s (LLY) Prozac is approved by the FDA to treat major depression in children.

Dr. Sandra Kweder, the FDA's acting director of the Office of New Drugs, said consumers should start to see the changes in four to six weeks.

"We want to get the message out that these drugs shouldn't be used casually," she said. But Kweder also said the FDA doesn't want to discourage the use of such drugs in children who could benefit from them.

Agency officials said each antidepressant will have its own black box, which will state whether or not the drug is approved for use in children. Some drugs, such as Pfizer Inc.'s (PFE) Zoloft, are approved for other uses in children, such as treating obsessive-compulsive disorder.

The agency's decision comes about a month after the FDA convened two outside panels of experts who looked at clinical trial data involving nine antidepressants. The panels concluded the data showed an increased risk of suicidal thoughts and behaviors, such as violence, and recommended the agency strengthen drug warning labels and adopt the "black box," the agency's strongest warning.

Along with Prozac and Zoloft, the clinical trial data involved Wyeth Laboratory Ltd.'s (WYE) Effexor; GlaxoSmithKline PLC's (GSK) Paxil and Wellbutrin; Forest Laboratories Inc.'s (FRX) Celexa; Remeron, made by Akzo Nobel NV's (AKZOY) Organon; Bristol-Myers Squibb Co.'s (BMY) Serzone; and Solvay SA's (SOLB.BT) Luvox.

A total of 24 trials involving more than 4,400 patients were included. An FDA analysis showed a greater risk of suicidal feelings during the first few months of treatment in those receiving antidepressants. The average risk of such events on drugs was 4%, twice the placebo risk of 2%. No suicides occurred during the trials.

The "black box" warning labels will apply to all antidepressants, which include several more drugs than the nine that were part of the FDA's analysis on drug and suicide risks.

FDA acting Commissioner Dr. Lester M. Crawford said antidepressants are effective and useful in children. He also said doctors and parents need to balance the risks and benefits of putting children on the drugs.