U.S. government regulatory staff have advised that even low-dose versions of a proposed depression patch called Emsam should carry black-box warnings against eating certain foods while on the medication.
Can Cause Heart Problems
Emsam is a monoamine oxidase inhibitor, or MAOI, which is a type of antidepressant that puts those who use it at risk of having heart problems if they eat foods containing tyramine, which includes smoked meats and dairy products.
Delivered Through the Skin
The manufacturer asked that the lowest dose of Emsam (20 milligrams) not carry the warning, as it is delivered through the skin and does not need to be ingested. The drugmakers claimed that clinical data showed that the drug was well tolerated without any dietary changes.
First Patch for Depression
The drug, known generically as selegiline, was conditionally approved in 2004. A final decision on it is expected in late November. If approved, Emsam will be the first U.S.-approved skin patch to treat depression.
