Menopause is back on the front burner for Big Pharma. A new campaign with full-age ads in the NYTimes promotes Novo-Nordisk’s hormonal products for hot flashes and atrophic vaginas. Lots of interactive online checklists to print out and take to your doctor. Similarly, a new campaign for “Osphena,” a Tamoxifen-like drug approved in February that supposedly helps with dry vaginas and painful intercourse also has lots of bells and whistles on their consumer website about how to assess yourself, talk to your doctor, share your story, etc.
None of these sites offer the full picture of benefits, harms, research limitations, and side effects. They are full of large print oversimplifications and small print disclaimers.
Now news comes that the FDA has approved a central-nervous-system drug, Brisdelle, to treat hot flashes. This was a BIG surprise to many since 3 months earlier the FDA Advisory Committee voted 10-4 not to recommend it, saying its risks outweighed its very small benefits. Brisdelle contains paroxetine, dosed in 7.5 mg daily capsules. Prescribed for depression, anxiety, PTSD, and OCD, the same compound, paroxetine (called Paxil), has a recommended starting dose of 20 mg./day and an average dose of 40mg./day+, and has had a black box warning since 2004 about the risks in pregnancy, of suicidality and with regard to withdrawal issues. At the same time the Committee voted 12-2 against another repurposed CNS drug for hot flashes — gabapentin/Sefelsa – and the company dropped the product when the FDA followed the committee’s advice.
Why did the FDA management override its own expert advisers on Brisdelle but not Sefelsa? The company, which now, of course has a new patent on paroxetine which has long been available as a generic, said in a statement that 24 million women in the United States alone have moderate to severe hot flashes and that two-thirds were not currently treating them. This is a marketer’s dream…ka-ching!!!
How many women will take this expensive new drug without knowing that it is an antidepressant and should be closely monitored for serious side effects? How many will take it knowing the benefits are trivial compared to placebo? I (KW) am sure that the community of patients/families harmed by antidepressants would be outraged to learn that these drugs were now being given to women for hot flashes. It’s important that their voices are included in any activism efforts and projects related to this recent FDA drug approval.
There must be something in the air about menopause to justify all this new pharmaceutical industry effort. Something about new insurance coverage, maybe, for all those baby boomers?