FDA approves depression patch

March 11, 2006 by  
Filed under DEPRESSION

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Thu 09 Mar 2006 12:00 AM CST

The Food and Drug Administration (FDA) approved the first antidepressant skin patch last month despite several warnings associated with the drug.

To be sold under the name Emsam, the transdermal patch delivers a monoamine oxidase inhibitor (MAOI), a chemical that blocks an enzyme in the brain that breaks down neurotransmitters.

Somerset Pharmaceuticals Inc. developed the drug, and Bristol-Myers Squibb Company will be marketing it.

Doctors usually don’t prescribe MAOIs unless a patient doesn’t have a favorable response to selective serotonin reuptake inhibitors (SSRIs) such as Prozac, Zoloft and Paxil.

That’s because MAOIs, when combined with certain foods, can suddenly increase a person’s blood pressure, putting him or her at risk for stroke or even death.

The Emsam patch will be available in three doses: 6 milligram, 9 milligram or 12 milligram of selegiline per 24 hours. The lowest dose can be used without dietary restrictions, according to the FDA.

The higher doses will carry a warning label listing foods and beverages patients should avoid while using the patch. Patients shouldn’t eat foods containing a substance called tyramine. This includes fava beans, draft beer, aged cheeses, red wine, salamis and soy sauce.

“The dietary warnings that will appear on the higher doses are the same as with any other MAOI,” said David Fassler, M.D., a clinical professor of psychiatry at the University of Vermont. “Psychiatrists are already familiar with the need for careful patient selection, education and monitoring when using these medications.”

The warning label will also stress that the patch is meant for adult use only. The FDA will require a warning about children and adolescents, who sometimes have suicidal thoughts and show suicidal behaviors when treated with antidepressants.

So, should you consider a prescription?

“MAOIs work best for those with an ‘atypical’ depression that hasn’t responded to treatment with an SSRI and/or an SNRI [serotonin-norepinephrine reuptake inhibitor],” Fassler said. “Because the mechanism of action is different, they are unique from other antidepressants. They do represent a significant alternative for the 30 percent of patients who don’t respond to other medications.

“It is a useful alternative in the continuum of treatment options. In the clinical trials, patient compliance was also much higher than it is with [oral] medication. This could also be an important factor for some patients who suffer from depression,” Fassler said.

To learn more visit myDNA’s Depression Center Read More

Reviewed: March 10, 2006 Rick Nauert PhD
Source: myDNA.com
Copyright: ©RHG


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