FIVE DAYS; BLACK-BOX WARNINGS

Source | New York Times

By Gardiner Harris

In 1962, the Food and Drug Administration reviewer who uncovered the dangers of thalidomide got a presidential medal. Yesterday, the F.D.A. safety supervisor who accurately warned about the heart dangers of the diabetes drug Avandia left the agency under a cloud.

Times have changed at the F.D.A.

In recent years, F.D.A. reviewers who uncovered drug dangers have been investigated criminally, rebuked publicly and threatened with retaliation.

This week, the F.D.A. disclosed in a Congressional hearing that it had asked GlaxoSmithKline, maker of Avandia, and Takeda Pharmaceuticals and Eli Lilly & Company, makers of a competing medicine, to carry the so-called black box warning of heart risks because ‘’despite existing warnings, these drugs were being prescribed to patients with significant heart failure.'’

The drug makers say such a warning takes weeks or months to put in place. The F.D.A., meanwhile, is working to make the black-box warnings more prominent on packaging.