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HERBAL CONNECTION HEALTH NEWS

FDA Strengthens Hormone Warnings for Women

By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news - web sites) strengthened warning labels on all women's hormone replacement therapy products on Wednesday, January 8th, warning of the risk of heart disease, stroke and cancer.

The widely expected move follows the surprise announcement last July that HRT, taken by an estimated 10 million women to treat the symptoms of menopause, raises the risk of heart disease, heart attack, blood clots and certain cancers.

All HRT products will have to carry a boxed warning about the risks, with suggestions about alternatives, said FDA commissioner Dr. Mark McClellan. "Our goal is to help clear up the confusion," McClellan told a telephone news briefing.

The studies that showed a higher cancer and heart disease risk used Wyeth's PremPro and related products, but McClellan said there was no reason to believe that other HRT products would not have similar effects.

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

He said the FDA was urging companies to find the lowest doses that could 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," 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 OUTWEIGH BENEFITS

It does help prevent bone fractures caused by osteoporosis, but in most cases the risks of heart disease and other health effects outweigh the benefits, health officials say. There are also drugs on the market that can prevent osteoporosis without having the dangerous side-effects of HRT, McClellan said.

He said the FDA was conducting a "careful review" of the study data to make sure HRT labels were 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," McClellan said. He said the FDA was 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 labeling, highlights the increased risks for heart disease, heart attacks, strokes, and breast cancer (news - web sites)," the FDA said in a statement.

"This warning also emphasizes that these products are not approved for heart disease prevention. 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, 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, 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," McClellan said.

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Want something different then HRT......try Rejuvenate for Women or Hot Mommies Essential 3

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Take Care,
Pamela Reynolds

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