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Depression patch needs warning: FDA staff

Posted on: Tuesday, 25 October 2005, 09:21 CDT

WASHINGTON (Reuters) - Low-dose versions of Somerset Pharmaceuticals Inc.'s proposed depression patch Emsam should carry a warning against eating certain foods while using the drug, U.S. health regulatory staff said in documents made public on Tuesday.

Emsam is a monoamine oxidase inhibitor, or MAOI, a type of antidepressant that already carries strong warnings about the heart risks linked to their use in combination with certain foods such as smoked meats and dairy products with the compound tyramine.

On Wednesday, a Food and Drug Administration advisory panel plans to discuss whether Emsam should also carry the warning on its label.

"I do not advocate approval of the 20mg (milligram) Emsam patch without tyramine restrictions and recommend that the FDA proposed text for labeling this issue remain," FDA staff reviewer Greg Dubitsky wrote in documents released ahead of the meeting.

Somerset is a joint venture of Mylan Laboratories Inc. and Watson Pharmaceuticals Inc.. Bristol-Myers Squibb holds U.S. and Canadian marketing rights for Emsam.

Shares of Mylan were down 12 cents at $20.98 in morning trading while Watson shares were off 7 cents at $35.78. Shares of Bristol-Myers Squibb were near unchanged at $21.63. All three companies trade on the New York Stock Exchange.

The documents were posted on the FDA's Web site at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-

Source: REUTERS

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