FDA's MedWatch Safety Alerts: August 2009

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Early Communication on Safety of Xolair

FDA is evaluating safety findings known at this point from an ongoing study of Xolair (omalizumab). Xolair is approved for use by people 12 years of age and older with moderate to severe asthma who react to an airborne allergen year-round and whose symptoms are not controlled well with inhaled corticosteroids.

The risk: These interim findings suggest an increase in adverse events involving the blood vessels of the heart or brain (cardiovascular or cerebrovascular events) in people treated with Xolair compared to another group of people not given the drug.

This type of communication (early communication) is part of FDA's effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion.

Recommendations:

• Do not stop taking Xolair without the advice of your health care professional.
• Talk with your health care professional about the risks and benefits described in the prescribing information for Xolair, as well as the new information from the ongoing study, called EXCELS.

Warning About Electronic Cigarettes

FDA’s laboratory analysis of electronic cigarette samples found diethylene glycol, a toxic chemical used in antifreeze, and cancer-causing substances (carcinogens). Also known as "e-cigarettes," these battery-operated devices turn nicotine, flavor, and other chemicals into a vapor that is inhaled by the user.

For a full consumer update, see FDA Warns of Health Risks Posed by E-Cigarettes.

Warning About Steroid-Containing Body Building Products

FDA has warned the public about potentially serious health risks associated with body building products that claim to contain steroids or steroid-like substances. Although marketed as dietary supplements, they are unapproved new drugs that have not been reviewed by FDA for safety and effectiveness.

For a full consumer update, see Warning on Body Building Products Marketed as Containing Steroids or Steroid-Like Substances.

For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).

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