FDA issues warning on menopause drug

The United States Food and Drug Administration (FDA) has issued an advisory asking women who use Evamist spray to keep it away from children as possible adverse effects include premature puberty among girls and enlarged breasts for boys.

The spray, prescribed to reduce hot flashes in menopausal women, is received on the inside of the forearm between the wrist and elbow. The FDA has asked users to ensure that children do not come in direct or indirect contact with Evamist.

Women using the spray should wear a long-sleeved garmet to cover the spray site and in the event of a child still coming into skin contact with it, they should immediately be washed with soap and water, says the advisory.

The FDA has been receiving reports about the effects of the spray over the last three years. Evamist was approved in July 2007. They received reports of eight cases where children got sprayed accidentally.

While the girls reported nipple swelling and breast development, the boys indicated that their breasts got enlarged. The FDA concluded that the adverse impact came to light several weeks or months after the adults in the family began using the spray.

In some cases the problems resolved once the adult stopped using the drug or took adequate steps to prevent the children coming into skin contact with the spray.

Evamist contains estradiol, an estrogen hormone. It is used in women to reduce hot flashes during menopause. Evamist is a topical product, sprayed on the skin on the inside of the forearm between the elbow and the wrist.

Reports of secondary exposure to Evamist in two spayed female dogs have been received by FDA's Center for Veterinary Medicine since 2007 and include signs of mammary/nipple enlargement, vulvar swelling, and liver failure in one case, and vaginal prolapse and elevated estrogen levels in the other.

The FDA said in a statement that it was reviewing these reported adverse events and is working with the company to identify any factors that may contribute to unintended exposure. FDA and the company are also evaluating ways to minimize the risk.

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