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FDA approves new non-hormonal menopause treatment

July 1, 2013 12:00:00 AM PDT
The Food and Drug Administration just approved the first non-hormonal drug to treat hot flashes.

More women used to be prescribed hormones for hot-flash relief. But ever since the 2002 Women's Health Initiative revealed hormone replacement therapy might be more harmful than helpful, hormone therapy use has dropped off significantly. Now the FDA has approved a new non-hormonal drug. But some critics question its effectiveness.

A study showed the off-label use of the antidepressant Lexapro can reduce the frequency of hot flashes. Now the FDA has approved a lower-dose form of another well-known antidepressant specifically for hot flashes.

"Brisdelle is actually the same ingredient that's in the FDA-approved medication Paxil, which is an antidepressant," said gynecologist Dr. Steven Rabin.

Rabin says research doesn't show it's significantly effective.

"The study showed that this particular drug reduced hot flashes, but only a little bit better than sugar pills," said Rabin.

Gynecologist Dr. Steven Rabin says labels on antidepressants warn these drugs can increase suicidal thoughts, may interfere with other medications and decrease a woman's libido.

The lowest dose of the antidepressant Paxil is 10 milligrams. Brisdelle contains 7.5 milligrams of the same ingredient. But experts say whether or not this reduces side effects remains to be seen.

"Nobody can say for sure. Brisdelle seems to have the same warnings in its packaging that its sister, at the full dose, has, so it didn't look like they were ready to say that it had significantly less side effects," said Rabin.

Rabin says women should have a discussion with their doctor before deciding on the best treatment approach for them.

"Looking at all of the news and the hoopla about this new, non-hormonal, FDA-approved drug, it sounds like we needed it, and I think that what we need is more clarification of the true risks and benefits of hormone-replacement therapy," said Rabin.

Brisdelle, manufactured by Noven, is scheduled to be released in November.


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