FDA Warns of Bogus BotoxLast Updated: April 20, 2015. Doctors should closely examine wrinkle-reliever packaging.
MONDAY, April 20, 2015 (HealthDay News) -- Counterfeit Botox may have been distributed to doctors' offices and medical clinics across the United States, the U.S. Food and Drug Administration warns.
The bogus Botox -- which is considered unsafe and should not be used -- was sold by an unlicensed supplier not authorized to ship or distribute drug products in the United States, the FDA said in a news release.
Packaging similarities between the fakes and the FDA-approved Botox, which is made by Allergan (100 units/vial), could cause health care professionals to mistake one for the other.
Approved Botox displays the active ingredient as "OnabotulinumtoxinA" on the outer carton and vial, the FDA said.
The outer carton of the counterfeit version says the active ingredient is "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA," according to the agency.
The FDA said the counterfeit product also can be identified in other ways. For instance, the vial is missing the lot number.
Injections of Botox -- a toxin produced by the bacterium Clostridium botulinum -- temporarily smooth facial wrinkles and frown lines. Botox is also used to treat severe underarm sweating, uncontrolled blinking and chronic migraine, according to the U.S. National Institutes of Health.
Health care professionals should check with Allergan to confirm that the distributor that provided the Botox is authorized to sell the product, the FDA said. Allergan's website lists authorized Botox suppliers.
Suspected counterfeit Botox products should be reported to the FDA.
There are no known cases of people harmed by the counterfeit version of Botox, the FDA noted. The approved product by Allergan is considered safe.
The U.S. Food and Drug Administration has more about counterfeit medicine.
SOURCE: U.S. Food and Drug Administration, news release, April 20, 2015
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