Oct 3 (Reuters) - U.S. health regulators have approved Pfizer Inc's menopause drug Duavee, which is designed to reduce hot flashes with fewer side effects than older hormone-replacement therapies.
The Food and Drug Administration said on Thursday it approved the drug to treat women with moderate to severe menopause symptoms and to prevent post-menopausal osteoporosis, a bone disease which can increase the risk of fractures.
The drug, which Pfizer is developing with Ligand Pharmaceuticals Inc, combines bazedoxifene - which belongs to a class of drugs known as selective estrogen receptor modulators, or SERMS - and conjugated estrogens, which are derived from the urine of pregnant horses and contained in the hormone replacement drug Premarin.
U.S. Census data from 2000 indicate there are about 37.5 million women reaching or currently at menopause, which typically occurs between the ages of 40 and 59, according to the Centers for Disease Control and Prevention.
Conjugated estrogens have been shown to increase the risk of uterine cancer, blood clots and strokes. Combining estrogens with progestin therapy can increase the risk of heart attacks, strokes, breast cancer and blood clots.
The FDA said the bazedoxifene component of the drug reduces the risk of endometrial hyperplasia, or excessive growth of the lining of the uterus. But the product's label will carry a boxed warning, the most serious type, reflecting the risk of estrogens.
Use of hormone therapy dropped significantly following the 2002 release of safety data from a big study published by the Women's Health Initiative.
The FDA said Duavee is only intended for post-menopausal women who still have a uterus and should be used for the shortest duration possible. If the drug is used only to prevent osteoporosis, "such use should be limited to women who are at significant risk of osteoporosis after carefully considering alternatives that do not contain estrogen."
The drug is expected to generate sales of only $161 million by 2017, according to Thomson Reuters data.
"Exercise is absolutely critical," says Susan Moores, a registered dietician. Exercise can be a powerful sleep aid, combating the sleep disturbances many women complain about. It has been shown to improve the whole gamut of menopause symptoms from hot flashes to mood swings. She says not to just focus on aerobic exercise, but also try strength training and relaxation techniques, such as yoga.
Flaxseed
"Flaxseed falls in the same camp as soy for the phytoestrogens," says Susan Moores, a registered dietician. One study by the Mayo Clinic found the incidence of hot flashes was reduced as much as 50 percent by consuming flaxseed. It is also thought to be very promising because, along with phytoestrogens, it also contains omega-3 fatty acids, which can aid in mood stabilization. According to A.D.A.M., an online health content provider, when compared to hormone replacement therapy, 40 grams of flaxseed was reported to be equally as effective in reducing hot flashes, vaginal dryness and mood disturbances.
Black Cohosh
Two German studies have shown black cohosh to be effective in reducing hot flashes, according to A.D.A.M. One study in particular showed 80 percent of women saw a decrease in hot flashes while using black cohosh. However, no long-term studies have been done and there have been reports of side-effects including upset stomach and low blood pressure, caution the experts at Harvard Medical School.
Natural Progesterone
This over-the-counter cure uses progesterone or progesterone-like compounds as the active ingredient. "Natural progesterone is a hormone and it works," says Dr. Marcie Richardson, obstetrician and gynecologist at Harvard Vanguard Medical Associates and Beth Israel Deaconess Hospital in Boston. "Skin creams that contain extracts of Mexican wild yams have been widely promoted for natural menopause relief for years," says Harvard Medical School. However, because of variation among products and the individual nature of skin's responsiveness, this method is not recommended by the North American Menopause Society, says Harvard. There's no safety data on this hormone, Dr. Richardson cautions. Learn more about the risks and benefits here.
Red Clover
Red clover is often used to reduce vaginal dryness and decrease hot flashes. The effectiveness of red clover is thought to be due to a plant-chemical, isoflavones, which has an estrogen-like effect in the body. However, according to Harvard Medical School, research results have been disappointing. Two studies published in the journal 'Menopause' found that women fared no better with red clover than a placebo for both hot flashes and vaginal dryness. Learn more about red clover here.
Omega-3 Fatty Acids
Fish isn't just delicious; it contains a valuable ingredient that may help stabilize your mood swings too -- omega-3 fatty acids. There have been some good studies to attest that omega-3 can help improve mood, says Dr. Marcie Richardson. There's also growing research that omega-3 fatty acids help fight heart disease. The best way to add this key ingredient to your diet is by eating fatty fish like salmon, tuna and trout.
Acupuncture
You wouldn't necessarily think that sticking needles in your body would be a helpful way to cure menopause symptoms, but when combined with other treatments, it can be helpful. Some controlled studies have shown some effectiveness in some woman for hot flashes, says Dr. Marcie Richardson. According to A.D.A.M., "both the World Health Organization and the National Institutes of Health recognize that acupuncture can be a helpful part of a treatment plan" for many illnesses, including menopausal symptoms.
Vitamin E
There has been a study, which showed a slight effect in decreasing hot flashes for women using vitamin E, says Dr. Marcie Richardson. Along with reducing hot flashes vitamin E may carry with it extra benefits, such as fending off macular degeneration, lowering blood pressure, and slowing the aging of cells and tissues according to A.D.A.M.
Cutting Down On Alcohol
Who hasn't felt the negative effects of drinking too much alcohol, such as trouble sleeping or feeling flushed? This goes double for women during menopause. The thing about alcohol is: women metabolize it worse than men and we metabolize it worse as we age, says Dr. Marcie Richardson. According to Harvard Medical School, alcohol can act as a trigger for hot flashes. And if that wasn't enough to ward you off the bottle, studies show that consuming alcohol regularly ups your risk for other conditions like breast cancer and stroke.
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