Paxil - Increased Suicide Risk

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Paxil - Increased Suicide Risk

US cites suicidal acts in adults on Glaxo's Paxil

(May 12, 2006) - Young adults who took GlaxoSmithKline Plc's antidepressant Paxil in clinical trials were more likely to report suicidal behavior than others who got a placebo, the company and U.S. regulators said on Friday.

London-based Glaxo said it voluntarily added the findings to the prescribing instructions on Paxil's label even though it was hard to tell if the drug caused the behavior.

Antidepressants already come with strong warnings that they may raise the chances of suicidal thoughts and attempts in some children and teenagers. The Food and Drug Administration has been studying whether the same risk applies to adults.

Glaxo said it analyzed data on nearly 15,000 patients who took part in studies of Paxil for depression and other mental illnesses.

Eleven Paxil patients, or 0.3 percent, reported suicide attempts in studies of adults with depression. That was higher than the one patient, or 0.05 percent, seen in placebo patients in the depression trials. No actual suicides were recorded.

Eight of the 11 Paxil patients were between 18 and 30, raising concerns about that age group in particular. The possible risk was spotted "despite substantial evidence of efficacy," Glaxo said in a letter to physicians.

"It is therefore important that all patients, especially young adults and those who are improving, receive careful monitoring during (Paxil) therapy regardless of the condition being treated," the letter said.

The company added that it was "difficult to conclude a causal relationship" between the behavior and the drug, which is known generically as paroxetine, and that it believed the benefits of treatment outweighed any risks.

"As the absolute number and incidence of events are small, these data should be interpreted with caution," Glaxo said.

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The FDA posted Glaxo's letter on its Web site with a statement reminding doctors to carefully monitor all patients being treated with Paxil.

Determining the effects of antidepressants on suicidal behavior has been a challenge for regulators because depression itself can raise the chances of suicide. Many psychiatrists have complained that the warning about suicidal behavior in children may scare off parents from effective treatment.

Sources: FDA website, UPI

Last updated: 05/06

Paxil - Increased Suicide Risk

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