FDA orders warning on Botox

Apr 30, 2009 6:05 PM

The FDA today ordered a black box warning on Botox, Botox Cosmetic and Myobloc, products that contain botulinum toxin, due to potentially dangerous side effects that include death in children.

The risk comes from the fact that once the botulinum toxin is injected into a patient, it can spread in the body and cause botulism. The symptoms include difficulty breathing and swallowing, muscle weakness, trouble talking or saying words clearly, loss of bladder control, double or blurred vision and drooping eyelids. Patients should seek immediate medical attention if they develop any of these symptoms. The FDA noted that these side effects can develop only hours after treatment or as long as several weeks later.

The drugs are approved to smooth wrinkles and treat muscle spasm conditions, including eyelid spasms, neck muscle spasms and excessive sweating (Botox), smoothing facial frown lines (Botox Cosmetic) and neck muscle spasms (Myobloc).

The FDA's move is based on a safety review that turned up cases involving children who had received botulinum toxin for muscle spasticity due to cerebral palsy, a condition the drug is not approved to treat. In some of these cases, the children were hospitalized and there were also reports of death.

In adults, the majority of the cases involved the use of the drug for treating muscle spasticity. In some cases, the patients were hospitalized and placed on a ventilator. There were several deaths in adults, but the FDA said these can't be linked conclusively to botulinum toxin because the patients also had complications from other conditions.

The FDA also is requiring manufacturers of the botulinum products to develop a medication guide about these risks for patients.

—Steve Mitchell, associate editor, Best Buy Drugs

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