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FDA: Hormone Therapy Drug Labels to Change

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FDA: Hormone Therapy Drug Labels to Change

Wed Jan 8, 5:23 PM ET  


By Keith Mulvihill


NEW YORK (Reuters Health) - The US Food and Drug Administration announced Wednesday that makers of estrogen-containing products that are used by women for menopause symptoms will be required to make label changes reflecting new safety concerns.


In addition, women who do decide to take the drugs are being advised to take the lowest dose for the shortest possible time.


The announcement comes six months after a US government-sponsored study, the Women's Health Initiative (WHI), was halted three years earlier than expected. The landmark study found that women taking a hormone replacement product had a slightly higher risk of heart disease, breast cancer, stroke and blood clots compared with women not taking the hormones.


In that study, women were taking the drug Prempro, a combination of estrogen and progestin. Another arm of the WHI, in which women are taking an estrogen-only product called Premarin, is ongoing. Women who still have a uterus typically take estrogen combined with progestin, while those who have had a hysterectomy take estrogen alone.


Shortly after the WHI was halted, Wyeth Pharmaceuticals made some labeling changes and the new labeling will affect the company's estrogen-containing products--Prempro, Premphase and Premarin. The FDA is also asking all other manufacturers of estrogen or estrogen/progestin products to make similar changes as well.


"Today the FDA is taking action to provide new advice to women who use or are considering using estrogen or estrogen with progestin," said the FDA's Commissioner Dr. Mark B. McClellan.


"Now a box warning about not using estrogens for cardiovascular protection and about the findings of the WHI has been added to these products," McClellan told attendees of a press conference.


Although the FDA never approved the drugs for heart disease prevention, many doctors prescribed the drugs "off label" because there was preliminary evidence that the drugs might be helpful.


Patient information that accompanies the products will be revised to reflect the new changes.


"Different estrogens and progestins are believed to act similarly, and in the absence of data suggesting otherwise, women need to assume that the risk of other estrogens and progestins are similar," said McClellan.


A labeling guidance policy will be published shortly for the manufacturers of these drugs, according to the FDA.


Currently there are three FDA-approved indications for the use of Prempro, Premarin and Premphase. One is the treatment of hot flashes and night sweats, two common symptoms of menopause. "This indication and the FDA labeling has not changed," said McClellan.


The two other indications have been revised, said McClellan.


While the drugs are still recommended for moderate to severe vulvar and vaginal atrophy symptoms, "we now state the when prescribing for solely the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered," McClellan said.


Although HRT drugs can still be prescribed to prevent the bone-thinning disease osteoporosis. the label will say they "should only be considered for women at significant risk for osteoporosis and nonestrogen treatments should be carefully considered," he said.


There are now several different drugs on the market for patients at risk for osteoporosis, including a class of drugs called bisphosphonates.


The FDA will continue to study whether low doses of the estrogen/progestin products are safer than higher doses, and compare the safety profiles of different types of products that contain the hormones.


Above all, a woman who uses or is considering using estrogen-containing products should consult her doctor regarding the individual risks and benefits of the hormones, McClellan said.



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