Drug Maker Issues Warning on Anti-Depressant Posted by Rob at 05/12/06 02:20 PM

In a letter to doctors, GlaxoSmithKline announced that its antidepressant Paxil may increase suicide attempts in young adults. This is likely welcome news for the many activists who have been working to strengthen oversight and warn the public about such dangers.

In the letter to doctors the company said:

it had changed the labeling on the drug to reflect the finding of the study, which analyzed clinical trial data involving some 15,000 people. The study found that reported suicide attempts were rare but significantly more common in adults who took the drug for depression than in those who received placebo pills.

You may recall that the FDA had previously required a new "blackbox" warning on antidepressants:

"Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents," the warning begins. It goes on to recommend that patients given the pills be closely observed, and notes that few antidepressants have proved effective against depression in children and teenagers.

The article describes the study's findings:

In the Glaxo analysis, the researchers analyzed trials that included 8,958 people who took Paxil and 5,953 who received placebo pills. The study participants ranged in age from 18 to 64 years old and were taking the medication for depression or other disorders, like panic attacks and obsessive compulsive disorder.

The analysis found that 11 of 3,455 people who were taking Paxil for depression reported an attempted suicide, compared with 1 in 1,978 taking placebo in the trials. Most were among adults ages 18 to 30, the company said.

The reporter also got comments from a practicing psychiatrist:

"The new findings are not going to change my practice a lot, but I say, yes, they provide a reason to do even more careful monitoring of people on the medication," said Dr. George Simpson, a professor in psychiatry and behavioral sciences at the Keck School of Medicine at the University of Southern California.

Dr. Simpson said the warning underscored the need for more careful tracking of side effects once drugs went on the market.

"The current system of postmarketing surveillance is lousy," he said.

Indeed, the saga of suicidality and antidepressants shows how bad our postmarketing surveillance system is, and how much transparency of clinical trial information is needed.

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