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The Game Is On – Menopausal Women a Huge Target for Antidepressant Medications

Menopausal women are a major target for drug companies and their respective antidepressant medications.  In June 2013, the FDA has approved Brisdelle for hot flashes.  The FDA approved the drug against the advisory panel’s recommendation.  Brisdelle, manufactured by Noven Therapeutics, is an antidepressant – it is Paxil (FDA approved in 1992) with another name and a different color.  While the drug achieved approval, studies showed that Brisdelle has a similar benefit to placebo – only 1 less hot flash per day.  Brisdelle also increases the risk of suicide and other risks.  There has been a significant amount of litigation centering on the side-effects and risks associated with Paxil.

Noven began marketing Brisdelle in November 2013.  In January 2014, Noven entered into a co-promotion agreement with Shionogi.  Under the terms of the multi-year agreement, the Shionogi women’s health sales force agreed to promote Brisdelle in the U.S. to a range of health care providers not currently detailed by the Noven Women’s Health specialty sales force, including select primary care physicians, beginning in February 2014.

The anti-depressant Effexor, manufactured by Pfizer, is also often used to reduce hot flashes.  A new study shows that after taking the drug for two months, women reported an average of 4 hot flashes per day instead of 8.  However, the placebo effect reported 8 hot flashes to 5.5 per day.  Like Brisdelle, Effexor also carries serious risks including suicidal thoughts and behaviors, chest pain, serious vision problems, sexual problems and sever confusion.

While use of antidepressants in menopausal women is not new treatment approach, drug companies are hoping to tap into a very profitable market.  Women will likely pay full price for a new product instead of buying a dated generic product.  Likewise, Brisdelle is approved at a lower dose of Paxil – Paxil’s lowest dose is 10 mg, whereas Brisdelle is approved for 7.5 mg.

Antidepressant medications carry serious risks.  Women should be cautious when taking these medications for hot flashes and speak with their doctor about the risks vs. benefits associated with the drug.

Claudine Q. Homolash, Esquire, founder of the CQH Firm, is a whistleblower, pharmaceutical injury and personal injury lawyer representing clients nationwide. She can be contacted at or (844) 677-4276 or (215) 496-1012  for a free legal consultation.

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