[ad_1]
Fake Botox is behind 19 reports of vision problems and difficulty breathing and swallowing in at least nine states, according to the report. The Food and Drug Administration said Tuesday.
The products in question were obtained from unlicensed fontsand “may be mislabeled, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe,” the agency wrote on its website.
“The sources of these products are unverified and unknown, so this situation is certainly concerning,” said Michelle Waltenburg, senior botulism epidemiologist at the Centers for Disease Control and Prevention. Waltenburg is working with the FDA and state health departments on the investigation.
Cases have been detected in Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington.
There is no indication that authentic Botox, made by the pharmaceutical company AbbVie, is related to any of the diseases. That product, the FDA said, “should be considered safe and effective for its intended and approved uses.”
Botox uses a purified form of a neurotoxin called botulinum toxin that paralyzes muscles for a period of time. Injected into specific areas of the face, it can relax the muscles that cause wrinkles.
The concern is that a counterfeit product could spread to other parts of the body, potentially incapacitating the muscles needed for breathing.
“Paralysis of the respiratory muscles is a very serious consequence,” Waltenburg said. “That’s why we consider botulism a medical and public health emergency and encourage people who have symptoms of botulism to seek medical care immediately.”
At least 19 women developed symptoms after receiving what they thought was real Botox, either from people who were never trained to give the injections or received them in “non-health care settings,” including homes or spas, CDC said Monday.
Almost all resorted to injections for aesthetic reasons. Most were around 40 years old.
Nine of those patients had to be hospitalized. Four were given botulism antitoxin because doctors were concerned the toxin could spread throughout the body. While some had difficulty breathing, none of the patients had to be put on a ventilator, Waltenburg said. No deaths have been reported.
The CDC is expected to alert doctors across the country about the problem starting Wednesday.
The FDA said there are several ways to identify counterfeit Botox products:
- The outer carton and vial contain lot number C3709C3.
- The outer box shows the active ingredient as “Botulinum toxin type A” instead of “OnabotulinumtoxinA.”
- The outer box and vial indicate doses of 150 units, which is not a unit manufactured by AbbVie.
- The outer box contains a language other than English.
Source link
