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A Belated Admission On Antidepressants By the FDA

Sep 16, 2004 | www.statesman.com

The Food and Drug Administration finally acknowledged publicly this week what some in the drug industry had known for a while but had declined to reveal: Antidepressants drugs such as Effexor, Paxil, Zoloft and Prozac appear to cause a small number of children and teenagers who use them to become suicidal or have suicidal thoughts.

And a scientific advisory committee voted 15-8 on Tuesday to recommend to the FDA that it put a "black box" warning on the labels for the antidepressants about the suicide risk for the youths who take them.

Legitimate questions have arisen about whether the drug industry wanted to keep quiet drug-test results that might hurt profits and about a federal agency more attuned to not irritating the drug industry than protecting the public welfare.

In February the FDA put a lid on findings by its own analyst, Andrew Mosholder, who warned of a link between use of the drugs and youth suicide.

Now he's been vindicated, and there's a bipartisan push in Congress to find out why this information was kept quiet for so long.

This week, Robert Temple, director of the FDA office of medical policy, said a review of 15 clinical trials some kept secret for years by drug companies show "there is an increase in suicidal thinking and action that is consistent across all the drugs."

There's also reason to believe that the danger of suicide from the drugs, however few children or teenagers it might affect, is not offset by doing good for many others.

"What is troubling is that millions of antidepressant prescriptions are written for depressed kids, when the facts show that six of the seven anti-depressants tested in pediatric trials did not show efficacy in kids," Rep. Greg Walden, R-Ore., said last week.

A House investigations subcommittee is studying use of the drugs and the suppression of clinical trial findings about their effects.

The industry has said the usefulness of the drugs remains undetermined even though almost 11 million prescriptions are given out a year.

Some parents strongly believe antidepressants have helped their children.

But other parents whose children have committed suicide while using antidepressants have criticized the FDA for taking too long to acknowledge the risks.

And British health authorities restricted most antidepressants for children and teenagers last December.

Congress must ensure that the information from drug trials is made public and that the FDA is not a party to suppressing information discomforting to the drug industry.

Parents have a right to know all of the risks their child takes with a drug, even if the risks are slight.

And if the FDA doesn't know what the risks of a drug are, why is it approving their use at all?


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