FDA Proposes Label Changes on HRT Drugs

[Guest guest]

Today I received the following message which I thought would be interesting to

the group members.

Ora

>To: DukeandtheDoctor_HRT

>Subject: [DukeandtheDoctor_HRT] FDA Proposes Label Changes on HRT Drugs

>

>Date: Fri, 13 Feb 2004 20:25:47 -0000

>

>

>WASHINGTON (Reuters) - Manufacturers of hormone replacement drugs

>should change their labels to tell women they can raise the risk of

>dementia and abnormal mammograms, the U.S. government said on

>Tuesday.

>

>Companies should also either specify the lowest effective dose or say

>the lowest effective dose has not been determined, the U.S. Food and

>Drug Administration said in a statement.

>

>The agency said it is requesting the label changes based on data from

>the Women's Health Initiative Memory Study, or WHIMS, published last

>year in the Journal of the American Medical Association.

>

>The study, conducted by the National Institutes of Health, showed

>estrogen with progestin drugs increased the risk of dementia in women

>ages 65 and older and did not prevent memory loss.

>

> " After thoroughly evaluating the WHIMS data, FDA is updating the risk

>and benefit information in product labels to help women and health

>professionals make informed choices about hormone therapies, " FDA

>Commissioner Mark McClellan said in a statement.

>

>A number of recent studies have found the controversial drugs -- also

>known as hormone replacement therapy or HRT -- can increase the risk

>of cancer, heart disease and blood clots.

>

>As a result prescriptions for the drugs have declined, falling from

>90 million in 1999 to about 57 million in 2003, according to a

>Stanford University School of Medicine report published last month.

>

>The new labels should include approved uses of the drugs, namely to

>treat moderate to severe hot flashes and night sweats, moderate to

>severe vaginal dryness, and to prevent menopausal-induced

>osteoporosis, the FDA said.

>

>They should also warn doctors to consider topical vaginal products,

>and the drugs should only be used to treat osteoporosis if the

>patient is at significant risk and non-estrogen treatments are not an

>option.

>

>The FDA also said it wants the labels to include the WHIMS data.

>

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