Monday, July 1, 2013

HOT FLASH DRUG NONHORMONAL: WHY FDA APPROVED POTENTIAL BRISDELLE PANEL AFTER IT HAS BEEN VOTED DOWN.

(CBS News) in an exceedingly surprise move, the Food associated Drug Administration has approved a replacement drug to treat hot flashes in biological time ladies once an federal agency panel voted against approving the medication.

The panel doubtless condemned of the drug, Dr. town Shirazian, a medical specialist at mountain peak Hospital in big apple, explained on "CBS This Morning," as a result of the scientific knowledge -- on that the panel depends -- was doubtless not compelling enough.

However, Shirazian noticed, the drug Brisdelle, made from paroxetine -- a generic medication that is used for systematic hot flashes -- has been used for years among OB-GYNs for the off-label indication to treat symptomatic hot flashes. it's been prescribed because the medicine paroxetime, but now, the new drug approved by the federal agency could be a lower indefinite quantity.

"The lowest dose of paroxetime is ten milligrams and this new drug is seven.5, thus it's a rather lower dose," Shirazian same. "We're terribly hopeful that it'll decrease a number of the aspect effects or adverse reactions to paroxetine that plenty of ladies face."

The drug decreases the intensity and severity of hot flashes. "With seventy five % of ladies full of hot flashes between the ages of forty five and fifty five, it extremely permits the bulk of ladies UN agency area unit biological time to profit from the (treatment of) symptomatic weakening problems that hot flashes bring every day," Shirazian same.

For women UN agency don't need to require medicine with hormones in them, Shirazian same this drug "definitely" represents a replacement reasonably science.

"There area unit plenty of ladies UN agency cannot use endocrine replacement medical aid, and that we perceive a lot of and a lot of concerning the problems associated with steroid and progestogen every day, "Shirazian same. "But ladies UN agency would like this area unit ladies UN agency have a history of blood clots, UN agency have family histories that area unit vital for blood clots, ladies UN agency have personal histories of carcinoma, ladies UN agency area unit mistreatment antagonist or ladies that have terribly vital family histories of carcinoma. thus it positively parades that door to a lot of folks."

For a lot of on this new drug, watch Shirazian's full interview higher than.

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