Depression patch needs warning: FDA staff

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-