FDA: Hormones get box warning, label changes

Estrogen products will contain more data on labels for physicians and patients.

By AMNews staff. Jan. 27, 2003. Additional information

The labeling of all estrogen and estrogen with progestin products for use by postmenopausal women will undergo important safety changes, according to a Food and Drug Administration announcement earlier this month.

These changes reflect the FDA's analysis of data from an arm of the Women's Health Initiative that raised concerns last summer and are part of a series of actions to provide advice to physicians who prescribe these products and risk management information to women.

"FDA's actions will help inform health care providers and their patients so that they can appropriately balance the benefits and risks to make the best possible decisions about use of these drugs," said FDA Commissioner Mark McClellan, MD, PhD.

In addition, the agency issued a new boxed warning that reflects the new risk information. It also outlines specific changes to indications for which these products are approved.

Overall, these warning and label changes are designed to emphasize the importance of individualized decisions that appropriately balance the benefits and the potential risks involved.

The FDA advises that nonestrogen treatments be considered first for postmenopausal osteoporosis.

The boxed warning, the highest level of warning information in labeling, also highlights the increased risks for heart disease, heart attacks, strokes and breast cancer associated with these hormones. It notes that these products are not approved for heart disease prevention.

Approved indications also have been modified to clarify that the drugs should be used only when the benefits clearly outweigh risks.

For instance, when prescribed solely for the prevention of postmenopausal osteoporosis, approved nonestrogen treatments should be carefully considered.

While the FDA did not make any modification for the treatment of moderate to severe vasomotor symptoms, it did advise prescribing these therapies at the lowest dose, for the shortest duration of time.

ADDITIONAL INFORMATION:

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Drug information on estrogen and estrogen with progestin therapies from the FDA's Center for Drug Evaluation and Research (http://www.fda.gov/cder/drug/infopage/estrogens_progestins/)

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