- WASHINGTON (Reuters) - Absent
any reason to believe any hormone replacement therapy products are fully
safe, the U.S. Food and Drug Administration said on Wednesday it was adding
labels to all HRT products warning of the risk of heart disease, stroke
and cancer.
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- The widely expected move follows the surprise announcement
last July that HRT, taken by millions of women to treat the symptoms of
menopause, raises the risk of heart disease, heart attack, blood clots
and certain cancers.
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- All HRT products will have to carry a boxed warning about
the risks, with suggestions about alternatives, said FDA commissioner Dr.
Mark McClellan.
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- "Our goal is to help clear up the confusion,"
McClellan told a telephone news briefing.
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- 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.
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- "Women need to assume the risk of other estrogens
and progestins are similar," he said.
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- He said the FDA was urging companies to find the lowest
doses that could ease the hot flashes and other serious symptoms of menopause,
and research whether lower doses would also lower the risk of cancer, heart
disease and stroke.
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- "A woman who is using or considering using estrogen
or estrogen-progestin treatment should consult with her health care provider,"
McClellan said. "In many cases a woman will still want to rely on
these products to deal with the effects of menopause. In other cases, alternative
treatment will be appropriate."
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- MORE RESEARCH UNDER WAY
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- HRT was, until last year, widely prescribed to treat
not only the immediate symptoms of menopause such as hot flashes and effects
on the genitals, but also to prevent heart disease and osteoporosis.
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- It does help prevent the 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.
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- He said the FDA was conducting a "careful review"
of the study data to make sure HRT labels were fully accurate.
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- "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.
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- 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.
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- The new labels will still show that HRT may be appropriate
for use in treating severe hot flashes and night sweats, McClellan said.
Other experts have said that short-term use of HRT will greatly relieve
such symptoms with potential little risk to women.
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- But for the dryness and irritation that sometimes come
with menopause, it may be better to use creams or ointments, and labels
will say that, McClellan said. And for simply preventing osteoporosis,
labels will say it may be better to look for an alternative product, such
as Eli Lilly and Co.'s Evista -- unless the risk of osteoporosis is severe.
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- McClellan said the FDA would work with manufacturers
to find out whether lower doses of HRT will lower the risks of cancer,
heart attacks, blood clots and other illnesses while relieving the symptoms
of menopause.
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- "We certainly want to encourage the lowest dosage
that provides relief," he said.
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- Wyeth said last year that prescriptions for PremPro fell
40 percent, and for Premarin 15 percent, after the studies emerged.
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