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July 1, 2005

FDA Warns Of Suicide Risks

The FDA recently posted a new warning on their website of the link between suicidal tendencies and adult usage of antidepressant medication. The FDA cited numerous publications that highlight the risk of suicide when taking antidepressant medication.

The FDA also posted information on a specific drug that may potentially have a link to increased suicidal tendencies. According to Mathews and Tesoriero (2005), "the FDA also last night posted information about patients who displayed suicidal tendencies during trials of one antidepressant, Eli Lilly & Co.'s Cymbalta, being tested for stress-related urinary incontinence. The site says a "higher-than-expected rate of suicide attempts was observed" in the studies after the formal portion of the trials had concluded.

The agency took the action despite earlier objections from Lilly. "Eli Lilly has questioned our legal authority under the Food, Drug and Cosmetic Act to post some information about drug safety on our Web site," Dr. Galson said, adding that Lilly "raised legal issues including our use of confidential commercial data." Lilly withdrew its application to market Cymbalta for the incontinence condition in January, but the drug is approved as an antidepressant and to treat pain suffered by diabetics."

Most of the FDA's warnings have been specifically for children and teens taking antidepressants but this article specifically highlighted the risks that such drugs held for adults. Eli Lilly states that the amount of patient who had such tendencies while taking Cymbalta is no more than there is in the general population. The placebo group supposedly had equal levels of suicidal tendencies.

The FDA has not passed judgement on whether this is a causal relationship. They only want to make sure that those taking the drug are aware of research that shows a potential link between the two so that they can take the precautions that they feel are necessary to take.

For the FDA website go to: http://www.fda.gov/default.htm

To access the FDA article go to: http://tinyurl.com/cdcuh

The source of this article was The Wall Street Journal.

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