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Friday, July 30, 2010

Two New Drug Risk Warnings from FDA

Estradiol Spray May Pose Risk for Kids and Pets - Menopausal women who use a spray form of topical estradiol (Evamist) to control hot flushes should avoid touching children and pets with treated areas of the skin, the FDA warned.

The agency said it had received eight reports of children ages 3 to 5 who showed breast enlargement and other signs of estrogen exposure after contact with women using the product.

Directions for use of the product -- approved in 2007 -- call for it to be sprayed onto the inside of the forearm.

"Patients should make sure that children are not exposed to Evamist and that children do not come into contact with any skin area where the drug was applied. Women who cannot avoid contact with children should wear a garment with long sleeves to cover the application site," the FDA recommended.

Continue reading: Product Alert, Rx from MedPage Today:

FDA Finds Pneumonia Risk with Daptomycin - The FDA said that the intravenous antibiotic daptomycin (Cubicin) may be linked to an increased risk of eosinophilic pneumonia -- a rare but serious potential side effect -- and requested that a new drug label warning be added. 

The agency reviewed the medical literature and adverse event reports for daptomycin and identified seven cases of eosinophilic pneumonia between 2004 and 2010 "that were most likely associated with Cubicin" on the basis of six criteria, the agency indicated in a Drug Safety Communication.

"Based on these reviews, FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label," according to the statement.

In 2007, the daptomycin label was amended to include pulmonary eosinophilia as a potential adverse reaction.

Continue reading: Product Alert, Prescriptions from MedPage Today:

Learn more about these drugs at RxList

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