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Determining drug risks

The Baltimore Sun

The Food and Drug Administration is requiring some drug manufacturers to determine whether participants in their clinical trials might commit suicide as a result of taking the tested drug. It's a hidden danger that has worried mental health experts for a number of years, so the FDA's action is a welcome, if overdue, step in ensuring the safety of those who take many of the drugs it approves.

In 2004, an increased risk of suicide became evident among children and teenagers taking antidepressants. At that time, the FDA issued a warning to doctors about the potentially harmful effects, and fewer antidepressants were prescribed for young people. But suicide risks are not limited to adolescents or to antidepressants. There are different categories of drugs, for illnesses such as obesity and epilepsy, that can affect the brain, perhaps causing someone with a previously healthy mental profile to contemplate suicide.

As drugs are tested in clinical trials, effects on the gastrointestinal system have been a key concern and manufacturers have documented negative reactions. While mental health specialists have warned that many drugs can trigger severe depression, the FDA did not require that any special attention be paid to the issue.

But that has changed, as reported recently in The New York Times. The agency is rightly looking for more reliable ways to assess suicide risks and other psychiatric problems before it approves a drug for the general market. It is asking some drug manufacturers to include as part of their clinical trials a questionnaire that examines suicidal thoughts and behavior.

The FDA is quick to point out that the suicide assessment is not being required across the board but on a case-by-case basis. It is being applied to new drugs that are in a class, such as antidepressants, that has been linked to suicide or when the clinical trial data suggest similar problems. That may affect only a handful of the approximately 100 drugs that the agency approves each year, and the agency should consider broadening the requirement.

A standardized assessment should give agency experts a more scientific basis for determining a drug's possible psychiatric side effects - and also help doctors and patients decide whether a drug poses more risks than benefits.

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