I’ve been successfully treating the symptoms of menopause for years and for less than 10 cents a day (Wal-Mart: 90 pills/$10 dollars). So when the FDA foolishly approved a reformulation of a generic drug, Paxil — used for years to treat depression — for the treatment of menopausal symptoms, I was horrified. The drug, renamed Brisdelle, cost as much as $6 a pill, and hardly worked better than a placebo. And one if its potential side effects, suicide, seemed a bit worrisome. A few months back, I wrote about Brisdelle and promised to present what I consider a far better alternative.
In 1959 the drug Aldactone (generic name of spironolactone) was approved to be marketed for the treatment of hypertension. It was largely unnoticed until a government-sponsored study, 40 years later, showed that this simple drug, when given to patients with congestive heart failure, could reduce the risk of death as well as any expensive branded medication or even an implantable defibrillator.
One of the unusual consequences of using spironolactone is that it has a feminizing effect in some people: As many as 10% of men can develop slight breast enlargement. Women, on the other hand, have noticed a reduction in facial hair and dermatologists have actually used this to treat women with a disorder known as hirsutism. For me, spironolactone has been a wonderful drug for the treatment of difficult-to-treat hypertension, patients with low potassium, and, of course, anyone with heart failure. For several years, I’ve used this to treat middle-aged women with hypertension who not only need their blood pressure cured but also their hot flashes, and I’ve seen a remarkable response. Many of my patients return with a lowered blood pressure and the resolution of their menopausal symptoms!
Spironolactone has been used for years in transgender (male to female) patients because of its antiandrogen effects as well as its progestrogenic and indirect estrogenic actions. Why no one seems to have considered this drug, especially in women who need to take something for their blood pressure, startles me.
Perhaps because spironolactone is generic, costs less than 10 cents a day and is therefore not highly profitable, it seems to have been abandoned as a potential breakthrough treatment for menopausal symptoms, similar to its obscurity in the treatment of heart failure, before a government-funded study showed how many lives it could save. Brisdelle, on the other hand, costing as much a $6 a day, with such dubious study results that an expert panel hired by the FDA voted not to approve it, is being marketed as a panacea for menopausal symptoms in direct-to-consumer advertisements.
Spironolactone may not be for everyone, especially in patients with renal failure or at risk of high potassium. But in most patients, it may be a far more reasonable treatment than Brisdelle, may be more effective, and could save our health care system billions of dollars.
Since industry and our major universities seem to have little interest in a cheap but effective generic drug, I am calling on our government, through this article, to find a study of spironolactone versus placebo in the treatment of menopausal symptoms. Until then, especially if you have hypertension and hot flashes, I suggest you contact your physician.
Evan S. Levine, MD, FACC is director of the Cardiovascular Center at St. Joseph’s Hospital and a clinical assistant professor of medicine at Montefiore Medical Center — Albert Einstein College of Medicine. He is also the author of the book What Your Doctor Won’t (or Can’t) Tell You and editor of the Journal of Medicine. He lives in Ridgefield with his wife and children.