Safety of Depression Drugs Questioned

An article by Gardiner Harris in the August 7, 2003 New York Times highlights the issue of the dangers of Paxil, one of the world's most prescribed antidepressants and about the entire class of these drugs that also includes Prozac and Zoloft. The article reports that unpublished studies about Paxil show that it carries a substantial risk of prompting teenagers and children to consider suicide. Interestingly enough, these studies also showed that Paxil was no more effective than a placebo in treating youths' depression, prompting regulators to recommend that doctors stop writting new Paxil prescriptions for patients under 18.

The US Food and Drug Administration is considering whether to impose new restrictions on the drugs' use. The article reports that of the 10 U.S. specialists on an FDA panel in 1991that formally cleared the drugs of any ties to suicide, seven now say that the new data would prompt them to reconsider that decision. Experts say the suicide risk is highest during young patients' first few weeks on the drug.

So far, there is little evidence that the warnings have affected doctors' prescribing practices. But the Times article notes that even doctors who doubt there is a link between the drugs and an increased suicide risk are emphasizing that patients need to be closely monitored in their first weeks on the medication. The FDA warned, parents shouldn't just take their children off Paxil or other antidepressants since patients can sustain severe withdrawal symptoms if the drugs are stopped abruptly.