HEALTH
FDA Warns Counterfeit Botox Linked To Outbreak In Multiple States
U.S. Food and Drug Administration
Counterfeit Botox injections have been linked to an outbreak that has sickened at least 19 people across 9 states, according to a Tuesday alert from the U.S. Food and Drug Administration.
Certain versions of botulinum toxin, known as Botox, are approved and widely popular for cosmetic use, in the form of facial injections meant to prevent or smooth wrinkles, as well as a variety of medical uses, including the treatment of migraines or overactive bladder.
One of the main effects of botulinum toxin is paralysis, which is how it prevents wrinkles and eases overactive bladders — by paralyzing the muscles. But when botulinum toxin spreads beyond the intended injection sites, it can cause botulism, symptoms of which include blurry or double vision, drooping eyelids, difficulty swallowing, difficulty breathing, difficulty moving the eyes, slurred speech and muscle weakness.
The FDA said it is aware of adverse events, including hospitalizations, linked to the counterfeit Botox. Symptoms included blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness and difficulty lifting ones head following injection of the counterfeit products.
The Centers for Disease Control and Prevention said that as of April 12, 19 people have reported harmful reactions after receiving botulinum toxin injections from unlicensed or untrained individuals, or in non-healthcare settings, such as homes and spas. Those cases were reported in Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington.
Nine of those individuals were hospitalized, and four were treated with botulism antitoxin. Of the 19 cases, 18 reported using Botox for cosmetic purposes.
The FDA said consumers should ask their providers if they are licensed and trained to administer Botox, and to ask if they are receiving product from an authorized source.
The agency said it is working with legitimate Botox manufacturer AbbVie to identify and remove suspected counterfeit Botox products found in the U.S.
AbbVie manufactures the authentic, FDA-approved Botox products in 50-, 100- and 200-unit dose forms. The product descriptions on the outer cartons are either “BOTOX COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX / for injection.” The manufacturer identified on the outer carton is either “Allergan Aesthetics / An AbbVie Company” or “abbvie.” FDA-approved Botox displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial.
TMX contributed to this article.
