Fake versions of Botox have appeared in California, causing concern among public health officials who warn that fake versions of the injections can lead to symptoms such as slurred speech and breathing problems.
“Counterfeit or incorrectly administered Botox, even in small amounts, can lead to serious health problems and even death,” warned Dr. Tomás J. Aragón, director of the California Department of Public Health, in a statement Wednesday.
Botox, or botulinum toxin, is used cosmetically to temporarily smooth fine lines on the face. It has also been used for treatment medical conditions such as muscle spasms. The product is derived from a toxin produced by bacteria.
Last month, the Centers for Disease Control and Prevention reported that 22 people from 11 states reported adverse reactions such as weakness and blurred vision after injections, leading some of them to be hospitalized. They were given their injections by unlicensed or untrained people or outside of health care, such as at home or a spa, according to the federal agency.
So far, there is no indication that such problems have been linked to the genuine Botox product approved by the federal Food and Drug Administration, health officials said. Instead, regulators discovered that some patients received counterfeit Botox products or products from unverified sources. Investigations are ongoing.
“We’re not even sure what it really is,” but it’s not Botox, said Dr. Adam Friedman, chairman of dermatology at the George Washington School of Medicine and Health Sciences.
And “when you have an injectable that’s not what it claims to be, has no quality assurance, no oversight … there can be a lot of different things along the way,” including bacteria or allergens.
Because health effects could be delayed, “I don’t think we’ve even scratched the surface” of the potential consequences of injecting an unknown substance into the body, Friedman said.
The California Department of Public Health said that since a multistate investigation began in November, it had received two reports of adverse reactions to botulism toxin adulteration or misuse, which were included in the total number reported. in national level from the CDC.
Under California law, Botox can only be injected by a doctor or a registered nurse or physician assistant working under the supervision of a doctor. However, state law “does not limit where Botox treatments can be performed,” according to the Medical Board of California. In a statement, Aragón urged people to only get Botox injections from “licensed and trained professionals in healthcare settings.”
Public health officials also advised consumers to check with their health care providers that they are getting Botox from an “authorized source” and to ask if they were licensed and trained to administer the injections.
“If in doubt, do not inject,” the public health department urged.
Aragón also emphasized that Botox should never be purchased online or through “unlicensed individuals.” Dr. Debra Johnson, past president of the American Society of Plastic Surgeons, said online sellers overseas have created “pirate Botox,” put it in similar packaging and then sell it to whoever will pay.
Doctors get emails and faxes saying, ‘We’ve got Botox for cheaper, we’ve got fillers for cheaper’ — and all these unregulated places have no FDA oversight whatsoever,” Johnson said. The doctors in charge know this is illegal, she said, but “I’m sure there are some people who would jump at the chance.”
Botox is manufactured by AbbVie Inc. The California Department of Public Health said the outer cartons of the genuine product include product descriptions of either “BOTOX® COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX® / for injection” and list the manufacturer as either “Allergan Aesthetics / An AbbVie Company” or as “abbvie”. They also list the active ingredient as ‘OnabotulinumtoxinA’.
Counterfeit products may list the active ingredient as “Botulinum Toxin Type A,” include languages other than English or indicate doses of 150 units, according to the California Department of Public Health. (AbbVie actually makes Botox products in 50-, 100-, and 200-unit dosage forms; federal officials said.) Another clue to a counterfeit product is the lot number “C3709C3” on the packaging or vials, regulators advise.
Fortunately, “there are some really key, distinct characteristics to this fake Botox that distinguish it from the real thing, which is not contaminated,” Friedman said. If a consumer is concerned, “there’s nothing wrong with saying, ‘Hey, can I check the box?’
In general, if “something seems too good to be true” or “seems like a deal when it comes to your health, those should be signals to run,” he said.
Anyone who has symptoms from fake Botox — which are similar to its effects botulism poisoning from improperly canned food; — should contact a doctor or go to an emergency room immediately, CDPH said. Symptoms may include drooping eyelids, difficulty swallowing, fatigue, weakness, and difficulty breathing.
Counterfeit Botox products can be reported to the FDA via his website or by calling (800) 551-3989. In California, people can also notify the California Department of Public Health by submitting a consumer complaint.