FDA Clears Antidepression Patch

Much of the delay in the FDA's approval focused on negotiations over dietary warnings placed on the label. If the agency had demanded restrictions as tough as those for selegiline pills, Emsam would lose much of its marketing advantage. The companies won a partial victory. The FDA won't impose dietary restrictions at the starting dose of 6 milligrams per 24 hours, but warnings must accompany higher doses of 9 milligrams or 12 milligrams per 24 hours.

Because the Emsam patch enables selegiline to be absorbed into the bloodstream, "initial exposure of the drug to the digestive tract is minimized," Bristol-Myers Squibb said Tuesday. Bristol-Myers Squibb noted that clinical trials didn't test whether higher doses of the drug were more effective than the starting dose. In order to reduce the risk of runaway blood pressure, patients must avoid high-tyramine foods while they take the higher Emsam doses, for two weeks after discontinuing treatment at those doses or while reducing the dose to 6 milligrams a day.

Emsam, which isn't approved for children, has a host of other warnings, including the general one required by the FDA that studies show antidepressants increase the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Federal law permits "off-label" prescribing of drugs. That means that once the FDA approves a drug for one disease, condition or group, doctors may prescribe it for uses not endorsed by the FDA.

Emsam's label also warns that the drug shouldn't be taken with a host of other antidepressants, certain analgesics and the supplement St. John's wort. Emsam users shouldn't drink alcohol.

Shares of Bristol-Myers Squibb were off 10 cents to $23.11. Mylan fell 82 cents to $22.85, and Watson dropped 36 cents to $30.

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