Show #51, May 2006
FDA Approves Emsam - First Drug Patch for Depression FDA recently approved the first transdermal drug patch for treating major depressive disorder. The patch, called Emsam and marketed by Bristol-Myers Squibb, is applied once a day to deliver the drug selegeline, an MAO inhibitor.
MAO inhibitors taken orally usually require specific dietary restrictions because when these drugs are combined with certain foods (such as aged cheeses), they can cause a hypertensive crisis. However, patients can use the lowest strength (6 mg per day) Emsam patch without observing these dietary restrictions. At the higher dosage strengths (9 mg and 12 mg per day) patients will still have to avoid these certain foods.
The manufacturer and distributor of this new product have planned an educational campaign for patients and prescribers to ensure that advice on dietary modifications for the higher patch strengths is adhered to. They are planning to conduct surveys to measure the effectiveness of the campaign, and they'll closely track adverse events for hypertensive events.
Although the effects of heat on the patch are not known, the drug labeling advises patients to keep the patch away from sources of heat because direct heat could increase the absorption of the drug. Patients should avoid exposing the patch to heating pads, electric blankets, heat lamps, saunas, hot tubs, or prolonged sunlight. And like other antidepressants, the Emsam patch carries a warning about the possibility of an increased risk of suicidality in children and adolescents.Additional Information:
