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The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.

Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were accidentally exposed to this topical estrogen product.

“Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “It is important that people know to keep both children and pets away from the product to minimize exposure.”

Evamist was FDA approved in 2007. From July 2007 to June 2010, FDA received eight post-marketing cases of unintended exposure to Evamist in children ages 3 to 5 years. Associated adverse events include premature puberty, nipple swelling and breast development in females, and breast enlargement in males.

Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA’s Center for Veterinary Medicine. Exposed pets could exhibit signs such as mammary/nipple enlargement and vulvar swelling.

Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child’s skin with soap and water if contact does occur. Do not allow pets to lick or touch a sprayed arm because small pets might be especially sensitive to the estrogen in this product. If direct contact with the Evamist sprayed arm can’t be avoided, women should wear something that covers that particular area.

At this time, it is unknown whether unintended exposure can occur with other topical estrogen products. The FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures.

Consumers and health care professionals should report any side effects from Evamist by using the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

The U.S. Food and Drug Administration (FDA) has notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug used for serious skin and bloodstream infections.

Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms include fever, cough, shortness of breath and difficulty breathing. The condition can lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed.

FDA has reviewed published case reports of Cubicin-associated eosinophilic pneumonia and conducted a review of post-marketing adverse event reports from the FDA’s Adverse Event Reporting System. Seven cases of eosinophilic pneumonia were identified between 2004 and 2010 that were likely associated with Cubicin.

Based on these reviews, FDA determined the illness could be linked to the drug and requested that the drug’s manufacturer include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label.

Healthcare professionals should closely monitor those being treated with Cubicin for eosinophilic pneumonia. Patients on the drug should immediately contact their healthcare professional if they develop a new or worsening fever, cough, shortness of breath, or difficulty breathing.

Additional information is provided in the Drug Safety Communication: Cubicin (daptomycin) Prescribing Information. Consumers can report serious adverse events to FDA MedWatch at: www.fda.gov/medwatch/report.htm.