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Stocks: Breaking News: FDA Warns Glaxo Over Paxil

Breaking News
FDA Warns Glaxo Over Paxil
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June 11, 2004

NEW YORK -(Dow Jones)- A television advertisement for GlaxoSmithKline PLC's (GSK) Paxil CR is "false or misleading" because it suggests that the drug can be used by a broader range of patients than it is actually approved for, the Food and Drug Administration said.

In a letter to the company, the agency also said the advertisements imply that the drug is safer than actually demonstrated and requested that the company immediately stop distributing promotional materials for the drug that make inappropriate claims.

A company representative for wasn't immediately available to comment.

"The TV ad suggests that anyone experiencing anxiety, fear or self-consciousness in social or work situations is an appropriate candidate for Paxil CR," the agency said in the letter posted Thursday on the agency's Web site.

Instead, Paxil Controlled-Release, is approved for social anxiety disorder, or SAD, which is different than the "lesser degrees of performance anxiety or shyness that do not generally require psychopharmacological treatment," the FDA wrote.

In addition, the television ad fails to communicate the major risks associated with Paxil, the agency said. It not only excludes mention of certain side effects, but also includes "compelling and attention-grabbing visuals" that distract consumers while risk information is read.

The company was given until June 23 to respond to the FDA in writing.

-By Mohammed Hadi, Dow Jones Newswires; 201-938-2007

(END) Dow Jones Newswires

06-11-04 0908ET

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