WASHINGTON, Oct. 25 (UPI) -- An advisory panel to the Food and Drug Administration will meet Wednesday to consider whether Somerset Pharmaceuticals' anti-depression patch Emsam should carry a warning about a possible "cheese reaction."
The FDA has given Somerset the go-ahead to market Emsam, a monoamine oxidase inhibitor, as soon as the labeling issue is resolved.
In documents released by the agency Tuesday, officials noted orally-administered MAOIs can block the body's metabolism of the dietary amine tyramine -- found at relatively high levels in foods such as aged cheese.
Tyramine can raise blood pressure if allowed into the bloodstream, and FDA is concerned patients with a major depressive disorder using Emsam in its 20-milligram patch formulation might still be at risk for the cheese reaction.
The agency is not bound to follow the advice of its advisory panels, but usually does so.
Somerset concedes its Emsam patch in 30 mg and 40 mg strengths should carry dietary restrictions on the label, but argues that substantial data show the 20 mg patch carries little risk of the cheese reaction.
Somerset is a joint venture of Mylan Laboratories and Watson Pharmaceuticals. Bristol-Myers Squibb has U.S. and Canadian marketing rights to the anti-depressive drug.
