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Medicalizing a normal phase of women’s lives — menopause — for the purpose of selling drugs began decades ago, and it continues on relentlessly. To wit: According to extensive advertising by the drug company Noven, menopausal women will this month have access to “the first and only FDA-approved non-hormonal therapy for moderate to severe hot flashes associated with menopause.”
The phrase “non-hormonal” alludes to the practice of hormone replacement therapy (HRT), a menopause treatment...
Medicalizing a normal phase of women’s lives — menopause — for the purpose of selling drugs began decades ago, and it continues on relentlessly. To wit: According to extensive advertising by the drug company Noven, menopausal women will this month have access to “the first and only FDA-approved non-hormonal therapy for moderate to severe hot flashes associated with menopause.”
The phrase “non-hormonal” alludes to the practice of hormone replacement therapy (HRT), a menopause treatment primarily involving estrogens, which was widely in vogue until its many threats to women’s health were documented. For every 1 million women using HRT for one year, there was an increase of 3,100 potentially life-threatening adverse events — namely heart attacks, strokes, blood clots and breast cancer — translating to an increase of 15,500 such serious adverse events per year for the (conservatively estimated) 5 million women who used HRT.
Because of these dangers, very few women now use HRT. So up steps Noven to fill the void with their new drug BRISDELLE, a drug also sold by GlaxoSmithKline as PAXIL (generic name: paroxetine), which is approved to treat depression, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder and posttraumatic stress disorder.
In March 2013, an advisory committee of the Food and Drug Administration reviewed the evidence for the effectiveness and safety of BRISDELLE to treat hot flashes. Public Citizen testified against approval, pointing out that the clinical trials failed to demonstrate any evidence of clinically significant benefits for paroxetine in comparison to placebo. We also presented evidence of previously documented dangers of paroxetine, including seizures or convulsions, manic episodes, agitation, sexual problems, and other adverse events found in studies of the drug.
The advisory committee concluded, by a 10-to-4 vote, that BRISDELLE did not provide a clinically meaningful improvement in hot flashes compared to a placebo, and an identical 10-to-4 vote also supported the conclusion that the drug’s benefits did not outweigh its risks and that it thus should not be approved. Yet in its desperation to provide a drug for hot flashes, the FDA unfortunately overrode the advice of the committee and approved the drug.
The January 2014 issue of Worst Pills, Best Pills News will discuss BRISDELLE in more detail, and explaining why we are categorizing it as a DO NOT USE drug.
