Fake versions of Botox have popped up in California, raising alarm among public health officials who warn that counterfeit 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 result in serious health problems and even death,” Dr. Tomás J. Aragón, director of the California Department of Public Health, warned in a statement Wednesday.
Botox, or botulinum toxin, is used cosmetically to temporarily smooth fine lines on the face. It has also been employed to treat 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 said that 22 people from 11 states had reported harmful reactions such as weakness and blurry vision after getting injections, landing some of them in the hospital. They had gotten their injections from unlicensed or untrained people or outside of healthcare settings, such as in a home or spa, according to the federal agency.
So far, there is no indication that such problems were linked to the genuine Botox product approved by the federal Food and Drug Administration, health officials said. Instead, regulators have found that some patients received counterfeit Botox products or ones from unverified sources. Investigations are underway.
“We’re not even sure what it really is,” but it’s not Botox, said Dr. Adam Friedman, chair of dermatology at George Washington School of Medicine and Health Sciences.
And “when you have an injectable agent that is not what it claims to be, has no quality assurance, no oversight … there could be a whole bunch of different things that come along for the ride,” including bacteria or allergens.
Because the health effects could be delayed, “I don’t think we’ve actually scratched the surface yet” of possible consequences from injecting an unknown substance into the body, Friedman said.
The California Department of Public Health said that since a multistate investigation launched in November, it had received two reports of harmful reactions to counterfeit or mishandled botulinum toxin, which were included in the total figure reported nationally by the CDC.
Under California law, Botox can be injected only by a physician, or by a registered nurse or physician assistant working under the supervision of a doctor. But state law “does not restrict where Botox treatments may be performed,” according to the Medical Board of California. In a statement, Aragón urged people to get Botox injections only from “licensed and trained professionals in healthcare settings.”
Public health officials also advised consumers to check with healthcare providers that they were getting Botox from “an authorized source” and to ask if they were licensed and trained to administer the injections.
“If in doubt, do not get the injection,” the public health department urged.
Aragón also stressed that Botox should never be purchased online or through “unlicensed individuals.” Dr. Debra Johnson, former president of the American Society of Plastic Surgeons, said that online sellers abroad have been creating “pirated Botox,” putting it in similar packaging, and then selling it to anyone who will pay.
Physicians have been getting emails and faxes saying, “‘We’ve got Botox for cheaper, we’ve got filler for cheaper’ — and it’s all these unregulated places that don’t have any FDA oversight,” Johnson said. Responsible doctors know that’s illegal, she said, but “I’m sure there’s some people who would hop at the chance.”
Botox is manufactured by AbbVie Inc. The California Department of Public Health said that outer cartons of the genuine product include product descriptions for either “BOTOX® COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX® / for injection” and list the manufacturer as either “Allergan Aesthetics / An AbbVie Company” or “abbvie.” They also list the active ingredient as “OnabotulinumtoxinA.”
Fake products might show the active ingredient as “Botulinum Toxin Type A,” include languages other than English, or indicate 150-unit doses, according to the California Department of Public Health. (AbbVie manufactures real Botox products in 50-, 100- and 200-unit dose forms, federal officials said.) Another tipoff to a fake product is the lot number “C3709C3” on packaging or vials, regulators have advised.
Thankfully, “there’s some really key, distinct features on this fake Botox that distinguish it from the real thing, which has not been contaminated,” Friedman said. If a consumer is concerned, “there’s nothing wrong with saying, ‘Hey, can I check out the box?’”
In general, if “something seems to be too good to be true” or “it seems like a bargain when it comes to your health, those should be signals to run,” he said.
Anyone suffering symptoms from counterfeit Botox — which are similar to the effects of botulism poisoning from improperly canned foods — should contact a medical professional or go immediately to an emergency room, CDPH said. Symptoms can include drooping eyelids, trouble swallowing, fatigue, weakness and difficulty breathing.
Fake Botox products can be reported to the FDA through its website or by calling (800) 551-3989. In California, people can also tip off the California Department of Public Health by submitting a consumer complaint.