Trading Down
Here we go again.
If you’re a woman experiencing menopausal hot flashes 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 by the FDA 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 flashes for something worse.
Tough cluster
The Obstetrics & Gynecology study comes from researchers at the University of Rochester who recruited 60 postmenopausal women and divided them into three groups: 20 received Neurontin, 20 received conjugated estrogens (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 flashes. 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.
Way off label
Here’s a chilling comment that appeared in an 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 flashes 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 he e-Alert “How Much is that Doctor in the Window?” (8/11/03) 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 flashes 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.
Know your options
If you’re coping with symptoms of menopause, you can explore treatments that don’t resort to drugs or synthetic HRT in these e-Alerts:
“Not so fast!” (4/24/06)
http://www.hsionline.com/ealerts/ea200604/ea20060424.html
“Matchmaker” (11/17/04)
http://www.hsionline.com/ealerts/ea200411/ea20041117.html
I also highly recommend an HSI special report titled “Look and Feel Your Best,” written by HSI Panelist Linda Page, N.D., Ph.D., a noted author and doctor of holistic medicine. Dr. Page emphasizes that menopause is actually nature’s way of protecting women from breast and uterine cancer by rebalancing hormone production. You can use this link for more information.
Hormone Replacement
and another thing
Unexpected weight loss may be a warning sign for middle-aged and older women.
When Mayo Clinic researchers compared medical histories of 560 dementia patients to a group of healthy control subjects, they discovered that women who developed dementia tended to steadily lose weight for several years before the first symptoms appeared.
The same trend was not seen in men with dementia.
Dr. David Kopman, who presented the study at the Alzheimer’s Association International Conference on Alzheimer’s Disease and Related Disorders earlier this month in Madrid, told Netdoctor that this finding might provide a clue to understanding processes in the brain that play a role in the development of dementia.
Some of the female dementia patients in the study began losing weight as much as a decade before cognitive decline became apparent.
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
“Weight Loss Linked to Dementia” Netdoctor, 7/17/06, netdoctor.co.uk