The Denver Post

Lawmaker worries that FDA may weaken drug warning
By Anne C. Mulkern
Denver Post Staff Writer

Thursday, September 23, 2004 - Washington - Federal drug regulators weakened new warnings on antidepressants, removing the suggestion that the medications might cause suicidal behavior, a congressman alleged Wednesday.

Labels now on the drugs don't use the same language as a stronger alert issued by the Food And Drug Administration in March, Rep. Maurice Hinchey, D-N.Y., said.

"It was important to determine why this label was weakened to ensure that it does not happen again," Hinchey said in a letter sent to FDA Commissioner Lester Crawford. Hinchey sits on the House Appropriations Committee.

Hinchey's letter comes as the FDA is debating whether to make drug companies add an even stronger warning to antidepressants. An advisory committee voted 15-8 to have the FDA require a "black box" warning, one of the strongest cautions the FDA can impose.

In an interview, Hinchey said that given the current weakened warning, he fears that the FDA will undermine its advisory committee's recommendation.

The FDA said that it was making the label more clear earlier this year and that it did not dilute the warning in any way.

FDA officials will appear today at a subcommittee hearing of the House Energy and Commerce Committee hearing looking at whether the agency overlooked safety concerns.

Following the recommendation of an advisory panel, the FDA in March issued an alert that advised doctors to watch for signs of worsening depression or suicidal behavior in antidepressant takers. That warning said that "worsening of symptoms could be due to the underlying disease or might be a result of drug therapy."

But when the proposed label was sent to drug companies, the FDA had dropped the line indicating that the suicidal thoughts or behavior "might be a result of drug therapy."

It added a line that said people can get worse "whether or not they are taking antidepressant medications." Other phrases were changed or moved.

"What was added in was more precise," said Dr. Steven Galson, acting director of the FDA's center for drug evaluation and research. "The overall meaning absolutely isn't different."

Mary Anne Rhyne, spokeswoman for GlaxoSmithKline, the maker of Paxil, said the company did not contest the language suggested by the FDA. Wyeth, maker of Effexor, tried to add label language that referred to higher risks for children and teens. The FDA told Wyeth that it had to use the same label as other companies.

Staff writer Anne C. Mulkern can be reached at 202-662-8907 or amulkern@denverpost.com .