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FDA Strengthens Hormone Warnings for Women
Wed Jan 8


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, 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 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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