FDA should order disclosure of risks with antidepressants

Miami Herald: The Food and Drug Administration should follow a panel's recommendation to warn doctors and patients in strong terms that some children and teens who take antidepressants might try to commit suicide.
The panel made the right call. Potential antidepressant users must be informed not only of the potential benefits of such drugs, but of the dangers, too. That hasn't been the case.
This week, the FDA panel heard testimony from grieving parents whose children had killed themselves and frightened parents whose kids had tried, but survived. Most said that they were unaware of the drugs' risks and that many doctors prescribed antidepressants without much thought.
The panel voted 15-8 that the FDA should require "black box" warnings on the information sheets that doctors use when prescribing the drugs.
The alerts would be published in bold-face type and surrounded by an eye-catching black border. Clearly, alerting physicians to the drugs' negatives will allow them and their patients to make better-informed decisions.
Questionable efficacy
The recommendation comes amid questions about antidepressants' overall effectiveness in children and adolescents. Several studies indicate that the drugs have questionable benefits in young people. This makes the risks, though low, intolerable.
The black-box decision is another significant step toward forcing pharmaceutical companies to disclose fully their products' effects. As outlined in The Herald's Sept. 12 story, "Truth, lies and Paxil," patients and physicians accuse manufacturers of withholding crucial information about some drugs' potential dangers. Indeed, the negative results of many clinical studies never are revealed to the people who need them most: doctors and patients. If doctors knew a drug's downside, the reasoning goes, they would better weigh the risk before prescribing it. Companies have a financial incentive to keep mum.
This is a dangerous practice that puts people at risk. Advocates wisely are taking action. The American Medical Association backs the creation of a government-monitored public registry on which all the results of clinical trials would be available. This idea should be implemented. Last week, editors announced that pharmaceuticals that want to tout their products in medical journals must post all clinical-trial results online.
We commend these efforts toward greater transparency and accessibility to crucial information.
Now the FDA should follow suit. Most over-the-counter drugs include long lists of potential side effects. The FDA should require no less from drug companies that produce antidepressants. Anything less than full disclosure is a threat to public health.