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.
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
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.
"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."
MORE RESEARCH UNDER WAY
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.
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.
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 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.
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.
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.
"We certainly want to encourage the lowest dosage that provides relief," he
said.
Wyeth said last year that prescriptions for PremPro fell 40 percent, and for
Premarin 15 percent, after the studies emerged.
