FDA Approves Transdermal Antidepressant Selegiline:
Come Get 1980's Medications in 2006
In the same season the FDA is raiding brilliant and creative compounding pharmacologist pharmacists for make natural tailored hormones, we see the FDA approve a transdermal medication that compounders have offered for decades. What is wrong with this picture?
The FDA has finally approved Emsam, a brand of selegiline, as a daily patch antidepressant. The patch will deliver this monoamine oxidase inhibitor antidepressant directly into the blood and will bypass the gut. It is nice that the FDA has decided to approve a medication that is already approved in oral form in a transdermal delivery form, especially since compounders are putting just about every medication through the skin for decades. One has the feeling this is perceived as real cutting-edge medicine. But compounding pharmacists do this routinely.
MAOI's like Manerix are not in the USA, but are in virtually all other civilized counties. This very special MAOI allows someone to eat any type of food.
The weakest Emsam 6 mg patch does not carry the typical dietary restrictions that are necessary when using oral MAO inhibitors. But some feel the 9 mg and 12 mg sized would require a patient to limit certain foods or drinks – highly fermented meats and drinks such as soy sauce, red wines, lunch meats, avoid aged cheese, aged or cured meats such as air-dried sausage, Marmite, sauerkraut, soy bean condiments, tap beer and fava beans. This amino acid can trigger severely high blood pressure that is dangerous.
Transdermal selegiline relieved depressive symptoms in two double-blind, placebo-controlled studies following more than 400 adult patients that had chronic recurrent major depressive.
Transdermal selegiline is directly absorbed slowly into the bloodstream, thus reducing the drug's initial exposure to the digestive tract. While patients using the 9-mg and 12-mg patches still need to avoid certain foods to reduce the risk of hypertensive crisis, the risk is possibly less than comparable oral doses, since fewer gut enzymes are knocked out.
Since not enough information is known about the tyramine food with 9 or 12 mg Emsam, the FDA suggests erring on the side of safety and avoiding certain foods.
Emsam has some side effects, including patch irritation of the skin, anxiety, light-headedness and low blood pressure. Heat from the sun or artificial sources are believed to increase the absorbed dose.
Like all approved antidepressants, the FDA has posted a warning of increased suicide in children and adolescents. Perhaps this is due to the routine excess starting doses of FDA approved starting doses, which increase agitation and restlessness.
We currently have a USA and international patent pending on a bio-identical transdermal antidepressant that is good for joints and the liver.