Heart disease, stroke and cancer warnings needed on HRT labels

The US Food and Drug Administration (FDA) has strengthened warning labels on all women's hormone replacement therapy (HRT) products, warning of the risk of heart disease, stroke and cancer.

(ABC News Online) The widely expected move follows a surprise finding last July that HRT, taken to treat the symptoms of menopause, raises the risk of heart disease, heart attack, blood clots and certain cancers.

FDA commissioner Mark McClellan says all HRT products will have to carry a boxed warning about the risks, with suggestions about alternatives.

"Our goal is to help clear up the confusion," he said.

The studies showed a higher cancer and heart disease risk for women who used Wyeth's PremPro and related products.

But Dr McClellan says there is no reason to believe that other HRT products do not have similar effects.

"Women need to assume the risk of other estrogens and progestins are similar," he said.

He says the FDA is urging companies to find the lowest doses that can ease hot flashes and other serious symptoms of menopause, and research whether lower doses would also lower the risk of cancer, heart disease and stroke.

"In many cases a woman will still want to rely on these products to deal with the effects of menopause," Dr McClellan said.

"In other cases, alternative treatment will be appropriate."

HRT was, until last year, widely prescribed to treat not only the immediate symptoms of menopause, such as hot flashes, but also to prevent heart disease and osteoporosis.

Risks

Health officials say HRT does help prevent bone fractures caused by osteoporosis, but in most cases the risks of heart disease and other health effects outweigh the benefits.

There are also drugs on the market that can prevent osteoporosis without having the dangerous side-effects of HRT, Dr McClellan says.

He says the FDA is conducting a "careful review" of the study data to make sure HRT labels are fully accurate.

"Second, we are issuing revised consumer and professional labeling to reflect the risks and benefits from PremPro, Premphase and Premarin. Now a boxed warning has been added to these products," he said.

He says the FDA is also requiring the makers of all estrogen-containing products to update their labeling to take account of the study's findings.

"The new boxed warning, the highest level of warning information in labelling, highlights the increased risks for heart disease, heart attacks, strokes, and breast cancer," the FDA said in a statement.

"This warning also emphasises that these products are not approved for heart disease prevention."

The FDA has also modified the approved indications for Premarin, PremPro, and Premphase to clarify that these drugs should only be used when the benefits clearly outweigh risks.

HRT may be appropriate for use in treating severe hot flashes and night sweats, Dr McClellan said.

Other experts have said short-term use of HRT will greatly relieve such symptoms with potentially little risk.

But for dryness and irritation that sometimes come with menopause, it may be better to use creams or ointments, and labels will say that, Dr McClellan said.

For simply preventing osteoporosis, labels will say it may be better to look for an alternative product unless the risk is severe.

The new labels also advise doctors to prescribe the hormones for the shortest possible time and in the lowest possible doses.

"We certainly want to encourage the lowest dosage that provides relief," Dr McClellan said.