Healthy Skepticism Library item: 871

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Kanapaux W.
FDA likely to add black box warning for antidepressants
First World 2004 Sep 24

Full text:

Dr. Robert Temple, the director of the FDA’s office of medical policy, told a congressional committee that the agency will likely require a black-box warning on all antidepressant drug labels, CBS MarketWatch and other news sources report.

A final decision on how to handle the warnings of a possibility of suicide risk from antidepressant use could come within days or possibly weeks, he said. A panel of outside experts recommended earlier this month that the FDA highlight the risk in the most serious warning label.

Temple said that the FDA is “thinking about” adding a black-box warning to labels of antidepressants but that the decision is “by no means final,” CBS MarketWatch reports. He noted that some groups have expressed concern to the agency that a black-box warning may scare physicians away from prescribing antidepressants to patients who need them.

The FDA could instead decide to use a bolded-print label for a similar effect, he said.

Temple also said at the hearing of the investigations subcommittee of the U.S. House Energy and Commerce Committee that the agency kept one of its researchers from presenting findings about the possible suicide risk of antidepressants last February because the data were unclear and needed more analysis, reports news sources.

“We didn’t think the information was wrong. We just didn’t think it was ripe yet. We thought the cases needed to be looked at before a conclusion was reached,” he is quoted as saying in news sources. “A premature conclusion … would be a disservice to the public health.”