I heard about people getting sick from injections of “fake” Botox.

The hyperhidrosis treatment BOTOX (see the Injections page in our Hyperhidrosis Treatments section) has long been known as a temporary cosmetic solution to facial wrinkles. BOTOX is also a promising new option for the treatment of hyperhidrosis. But whether you are seeking help for wrinkles or excessive sweating – events in the news are a reminder to “accept no imitations.” BOTOX, manufactured by Allergan, Inc. of Irvine California, is the only botulinum toxin product that is FDA-approved and U.S. licensed.

According to the New York Times, because of BOTOX’s popularity, particularly for cosmetic uses, there is a growing underground market for do-it-yourself or illegally imported anti-aging compounds that are supposed to do what BOTOX does, at a fraction of the cost. The problem is that these compounds have not been approved for use in the United States and may not be safe. A 2004 case of four people hospitalized with potential botulism poisoning after receiving wrinkle treatment injections from a former osteopath in Southern Florida emphasizes the dangers of unlicensed and unregulated cosmetic practices. Included among the four ill were the doctor himself, his assistant, and two clients.

According to experts interviewed for the New York Times, it is “next to impossible to contract a case of botulism poisoning from BOTOX.” The Allergan product BOTOX has been studied clinically for 20 years and has been FDA-approved for use in the United States for 15 years. Over 1 million patients worldwide with conditions caused by certain neurological disorders have been helped by BOTOX.

Allergan takes the issue of unlicensed drugs and the potential danger they pose to the public health very seriously. BOTOX, says the company, is a medical product that is subject to extraordinarily rigorous quality control and quality assurance processes that are overseen by regulatory authorities. The company has in place a number of measures to deter the sale or distribution of unlicensed alternatives to BOTOX. For instance, Allergan uses easy-to-identify holographic film on the BOTOX vials which physicians can use to determine receipt of authentic product. The company also has a sophisticated system in place for tracking the shipment of each BOTOX vial sold.

To ensure that they are receiving the real thing, patients seeking treatment with BOTOX are advised to use common sense when choosing a physician and to research his or her credentials and training. And, says a spokesperson for Allergan, patients should always verify with their physicians that they are receiving BOTOX and not an unlicensed botulinum toxin. Licensed products available in the U.S. can be verified by checking the FDA’s web site at www.fda.gov. Physicians and consumers with questions may also call 1-800-433-8871 to speak to an Allergan representative.

Pin It

Print   Email