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Menopause: The epilepsy drug being used to treat menopausal women
Here we go again.
If you're a woman experiencing menopausal hot flushes you have a number of treatment options. How about using a drug called Neurontin? That's what some doctors may ask their menopausal patients on the heels of a recent Neurontin study that appeared in the journal Obstetrics & Gynecology. Of course, doctors probably won't mention that the drug has only been approved as an epilepsy seizure medication.
This 'off label' use is completely legal as long as a drug company doesn't promote a drug for conditions it hasn't been approved for. But before women hop on board for this non-HRT treatment, they should know that we've been down this road before with Neurontin. And the side effects of the drug might have women wondering why they traded hot flushes for something worse.
Menopause: Tough cluster
The Obstetrics & Gynecology study comes from researchers at the University of Rochester in the US who recruited 60 postmenopausal women and divided them into three groups: 20 received Neurontin, 20 received conjugated oestrogens (that is: synthetic hormone replacement therapy - HRT), and 20 received a placebo.
After 12 weeks, Neurontin was found to be just as effective as HRT in treating hot flushes. And that's a key selling point for doctors whose patients have heard all about the serious health risks associated with synthetic HRT after a series of high-profile studies were abruptly halted in order to protect subjects.
But I hope that any woman who's offered Neurontin will ask about side effects. Because the Rochester study found that a cluster of symptoms - headache, dizziness and disorientation - occurred in significant numbers in the Neurontin group, compared to placebo. Researchers estimate that one in four users may experience the cluster of side effects.
Menopause: Way off label
Here's a chilling comment that appeared in a US Ivanhoe Newswire report on the Rochester study:
'Researchers say gradually increasing to the recommended dose and taking the drug with food can get rid of the side effects.'
Increase the dose! Does that seem like safe advice for a drug that's not even approved for hot flushes and has been tested for that condition on only 20 women?
Unfortunately, Neurontin's off label use has a history of this shoot-from-the-hip approach. In a past e-Alert I told you how Warner-Lambert (the original manufacturer of Neurontin) turned the drug into a major moneymaker, racking up huge sales from off-label use. According to a 2002 New York Times article about Neurontin lawsuits, court records show that Warner-Lambert sales reps were extremely aggressive in rewarding doctors who prescribed high volumes of Neurontin.
In 2003, Pfizer executives (who now produce the
drug) estimated that off-label use still made up more than 75 percent of Neurontin sales. With the publication of this new study it appears that trend may still be going strong.
I wonder how many women with hot flushes would feel comfortable taking a drug if they knew it was designed to control epileptic seizures, but was also heavily promoted to treat this, that and the other thing? It's enough to make you headachy, dizzy and disoriented.
Sources:
'Gabapentin, Estrogen, and Placebo for Treating Hot
Flushes' Obstetrics & Gynecology, Vol. 108, No. 1,
7/1/06, greenjournal.org
'Seizure Drug as Effective as Estrogen for Hot
Flashes' Ivanhoe Newswire, 7/5/06, Ivanhoe.com
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