Botox to Carry “Black-Box” Warning Label for Serious Health Risks

Posted on April 30, 2009 in Consumer Goods, Health & Medicine, Recalls

Botox injections are the most popular cosmetic procedure in the United States, with over 3 million procedures performed every year. Now, new findings have prompted the Food and Drug Administration to increase the danger level of botox injections to the most stringent black-box warning label. The black-box label is reserved for substances that could lead to serious injury or death.

Butolinum toxin, the primary agent of Botox, causes muscle weakness and paralysis. It is used in small amounts to relax frown lines as well as to cure muscle spasms, excessive sweating, and crossed eyes. Its reclassification has followed a number of cases where the toxin migrated to other parts of the body creating muscle weakness, difficulty speaking, loss of bladder control, trouble breathing, trouble swallowing, impaired vision, and drooping eyelids. In rare cases the effects on the lungs and heart proved fatal.

So far, all of the patients who experienced serious side effects were injected with botulinum toxin for unapproved uses or in excessive amounts.

“Botulinum products have benefits but also can cause serious problems so it’s important that anyone who administers or receives these products understand the risks involved,” said Dr. Ellis Unger, deputy director of the FDA, on the new black-box labeling. He added that there are no known cases of serious side effects in patients who received Botox injections in the approved dosage.