The therapy, once prescribed to millions of women to ease the immediate
symptoms of menopause and to prevent osteoporosis and heart disease, has been
found to increase the risk of heart disease, cancer and blood clots.
"Menopausal hormone therapy is a major personal decision for women and they
need to be armed with the latest facts," FDA Commissioner Dr. Mark McClellan
said at a news conference.
"It is very important that women realize that this beneficial therapy also
carries significant risks. Our recommendation is that if you choose to use
hormone therapy for hot flashes or vaginal dryness, or if you prefer it to other
treatments to prevent thin bones, take the lowest dose for the least duration
required to provide relief," McClellan added.
Researchers stopped a large study of HRT in July 2002 when it became clear
the therapy increased the risk of heart disease, cancer and blood clots. A
number of studies since then have supported those results.
"In January 2003, based on the findings of the ... study, FDA advised women
and health care professionals that menopausal hormone therapy -- estrogen and
estrogen with progestin -- is associated with an increased risk of heart
disease, heart attacks, strokes, and breast cancer." the FDA said in a statement.
"The warning emphasized that these products are not approved for heart
disease prevention."
But the specific risks vary from woman to woman and hormones are the only
drugs that can relieve symptoms such as hot flashes and vaginal dryness and
irritation. So the FDA has advised that HRT can still be used -- but at the
lowest dose that works and for the shortest possible length of time.
The FDA devised the education campaign after a request from a House
Appropriations subcommittee.
Many women became confused when they learned about the dangers of HRT, said
one subcommittee member, Connecticut Democratic Rep. Rosa DeLauro.
"Suddenly, millions of women didn't know what to do about hormone therapy,"
she said. Many, including DeLauro, immediately stopped taking HRT, she said.
The FDA has set up a Web site http://www.4woman.gov to provide
information and the agency has planned a broadcast campaign to educate women,
McClellan said.
