Toxic ‘fake Botox’ case linked to Washington

Public health officials in King County have stated there are five cases in Washington appearing to be linked to counterfeit or mishandled Botox, making people sick across the country. Federal officials are investigating reports of sickened individuals across nine states.

The Centers for Disease Control and Prevention (CDC), several state and local health departments and the U.S. Food and Drug Administration (FDA) have recorded 19 cases of people who received injections of counterfeit or mishandled botulinum toxin (commonly called “Botox”) as of April 16. Those affected reported experiencing symptoms similar to botulism, a serious illness that attacks the body’s nervous system, causing weakness and muscle paralysis. Nine of the 19 people had to be hospitalized.

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“We are currently aware of five cases in King County that appear to be linked to this ongoing national investigation,” the King County Department of Health stated. “However, FDA is currently investigating and has not confirmed if the cases are a result of a potential counterfeit or mishandled product or a result of Botox side effects.”

The CDC said the cases all involved women between the ages of 25 to 59. All reported receiving injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas. Along with Washington, other cases have been reported in Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York and Tennessee.

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The source of the harmful reactions appears to be a counterfeit version of the FDA-approved Botox product. Botox has gained popularity over the past two decades as a drug used to smooth wrinkles and appear younger. The American Society of Plastic Surgeons estimated the average cost of injections to be around $530, with effects lasting approximately three to four months.

Health officials said there is currently no indication that the genuine product, manufactured by the company AbbVie, is linked to any of the recent events. The FDA is looking into where the counterfeit products may have come from. More information about the fakes, and how to spot them, may be found on FDA’s website.

Anyone who suspects they may be experiencing a harmful reaction to botulinum toxin injections is urged to call the health department immediately for consultation and antitoxin release. If no one answers, contact the CDC clinical botulism service 24/7 at 770-488-7100.

Symptoms of a possibly adverse reaction include blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness and difficulty lifting one’s head following injection of these products.

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Healthcare professionals and consumers should report adverse events related to the use of any medications, including suspected counterfeit medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

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