The FDA approves a drug to treat the symptoms of hot flashes offering a new alternative to menopausal women, but this move is not without controversy.
If you are of a certain age then you may be all too familiar with the unwanted symptoms of menopause, and when a new clinical trial brings hope for relief it is welcome news but, the FDA's approval of a non hormonal drug to treat hot flashes is receiving mixed reviews.
"Sleep disruption, night sweats, some people say cognitive decrease like fuzzy thinking, certainly some problems in the vaginal and bladder areas are just some of the symptoms affecting most menopausal women." Said Dr. Michael Swor of Swor Women's Care in Sarasota.
Vonnie Weaver who works at Swor Women's Care said that the phones are already ringing with questions about the FDA's approval for the first non hormonal drug to treat how flashes. But, she also understands that women are seeking relief from symptoms because she is also a patient.
"It doesn't feel good when you wake up at night sweating wet, or you feel the hot flash coming on when it starts at the top and works your way down to your body."
Dr Swor explained that the drug is not new. "It's a new version of an old drug called Paxil which is an SSRI an anti depressant actually."
The drug developed by Noven Pharmeceuticals will be called Brisdelle and consists of a low dose of Paroxetine used at higher doses in Paxil.
"We had mixed results with the use, there are some significant side effects to be aware of." Said Swor.
And those side effects according to Brisdelle's label may include an increase in suicidal thoughts or behavior, increased risk of bleeding and may possibly reduce the effectiveness of the breast cancer drug Tamoxifen when used in conjunction with it.
Dr Swor added that a lot of the patients receiving the placebo drug also got benefit.
The advisory committee to the FDA voted against Brisdelles approval ten to four in march, so how does a drug with these findings get approved?
"Well, the FDA does some mysterious things." concluded Dr Swor.
Although the FDA doesnt have to follow the recommendations of its advisory panel, it is unusual for a drug receiving such a negative vote to be approved