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New HRT Warning Label

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http://www.medscape.com/viewarticle/447629 FDA Approves New HRT Warning Label

 

 

Jeanie Davis

 

Jan. 8, 2003 — The U.S. Food and Drug Administration (FDA) has asked that all

labels on estrogen and estrogen-progestin replacement therapy be revised to

carry a boxed warning, stating the increased risks for heart disease, heart

attacks, strokes, and breast cancer. The warning also emphasizes that these

products are not approved for heart disease prevention.

 

" We have approved all new labeling for Wyeth Pharmaceuticals for Prempro,

Premarin, and Premphase, " said FDA spokesperson Pam Winbourne, in a

teleconference with reporters. " All other manufacturers are being faxed letters

asking them to revise their labels in a similar fashion.

 

" We believe that different estrogens and progestins act similarly, and in

absence of data otherwise, women need to assume the risk with other estrogens

and progestins are similar, " said Ms. Winbourne. " Other studies do show that

estrogens and progestins are associated with these same side effects. "

 

The label also urges that physicians prescribe the lowest doses of estrogens and

estrogen-progestin products and for the shortest duration to achieve treatment

goals.

 

The label changes reflect findings from the Women's Health Initiative (WHI), " a

landmark study that found overall health risks for estrogen with progestin —

particularly for invasive breast cancer, heart attacks, blood clots — and that

these risks exceeded benefits of fracture and colon cancer risk reduction, " said

Ms. Winbourne.

 

The FDA also conducted its own review of data from the WHI, and confirmed the

study's findings. " We are assuring that labels...have accurate information as

uncovered by the WHI, " she said.

 

The black-box warning asks that decisions about using hormone replacement

therapy balance the benefits and potential risks.

 

" Our actions also include new guidance for conduct of clinical trials developing

products for vasomotor symptoms and vulvar and vaginal atrophy, " Ms. Winbourne

added, including treatment of the following specific conditions:

 

 

Moderate to severe vasomotor symptoms (hot flashes and night sweats). " The

FDA still believes that these products are highly effective and very valuable in

treating moderate to severe symptoms of hot flashes and night sweats, " said Ms.

Winbourne. " These symptoms can be very disruptive and often can only be

controlled by estrogen products. That will not change. "

Vaginal and vulvar atrophy. The new label states that when estrogen products

are being considered only for this condition, topical vaginal products should be

considered.

Prevention of osteoporosis. The new label states that when prescribing solely

for prevention of osteoporosis, estrogen should only be considered for women at

significant risk of osteoporosis — and that nonestrogen treatments such as

bisphosphonates should be carefully considered.

 

 

 

Some 6.5 million women in the U.S. now take some form of hormone replacement

therapy, Winbourne said.

 

Reviewed by Gary D. Vogin, MD

 

Jeanie Davis is a staff correspondent for WebMD.

 

 

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