FDA approves patch to treat depression

Drug label will carry warning about dietary restrictions

Mental health videos

Survey says country seriously stressed out
Oct. 7: More than one-half of Americans recently polled report increased stress over the last year, and one-third categorized their stress levels as extreme. NBC's Dr. Nancy Snyderman reports.

Survey: Economy stressing out Americans

Wechsler: Stress aging is ‘reversible’

Stress levels soaring, survey says

Dealing with financial anxiety

updated 1:38 p.m. ET Feb. 28, 2006

WASHINGTON - Federal regulators approved the first antidepressant skin patch on Tuesday, providing a different way to administer a drug already used by Parkinson’s disease patients.

The Food and Drug Administration approved the selegiline transdermal patch, agency spokeswoman Susan Cruzan said. The drug belongs to a class of medicines that is rarely a first or even second choice to treat depression.

It will be marketed as Emsam, said Somerset Pharmaceuticals Inc., which developed the drug, and Bristol-Myers Squib Co., which will market it.

Story continues below ↓

The FDA will require the drug to bear a so-called “black-box” warning of the risks of suicidal thoughts and behaviors in children and adolescents treated with antidepressants. The drug is meant for use only by adults.

The drug’s label also will carry a long list of foods, drinks and other drugs that patients must avoid while using the Emsam patch. The warnings are typical of the class of drugs to which it belongs.

Selegiline, approved by the FDA in 1989 to help treat Parkinson’s disease, is a monoamine oxidase inhibitor, or MAOI. Typically, doctors prescribe MAOIs only if patients don’t respond to other antidepressants, including selective serotonin reuptake inhibitors like Prozac, Zoloft and Paxil.

Although health officials say MAOIs are safe when used correctly, the drugs can cause dangerous interactions, including sudden and severe rises in blood pressure that can lead to a stroke, when patients consume food or drinks that contain a substance called tyramine — found in draft beer, red wine, fava beans, salamis, aged cheeses, soy sauce and other products.