WASHINGTON, Oct 15, 2004 (United Press International via COMTEX) -- The U.S. Food and Drug Administration Friday ratcheted up warnings on pediatric anti-depressant drugs for patients and healthcare providers.

Acting FDA Director Dr. Lester M. Crawford said there has been tremendous public interest in anti-depressant medications given to children since reviews of Paxil indicated a statistically significant risk of suicidal thoughts in children who took the drug.

Crawford outlined four strategies to better inform patients and doctors, including issuance of a public health advisory about the increased risk for suicidal thoughts and behaviors, requiring pharmaceutical companies that make anti-depressants to use "black box" warning labels on the products, requiring a medication guide be dispensed with each prescription fill or re-fill, and working with drugmakers to make anti-depressants available in unit packaging sealed for each use.

The goal is not to prevent pediatric use of anti-depressants because of the increased risks, Crawford said, but to "encourage providers to balance this risk with clinical need."

Prozac is the only drug approved to treat depression in children and adolescents but FDA reviewed clinical studies on the other major anti-depressants on the market in making its decision.

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