The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are investigating 19 cases of botched Botox reported across nine states in the United States.
Officials said that all the incidents involved women who either reported sick following the administration of counterfeit Botox injections of AbbVie or those who received injections from unlicensed or untrained individuals in non-healthcare environments.
"As of April 12, 2024, a total of 19 people from 9 states have reported harmful reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas. States reporting these reactions include Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington," the CDC said in a news release.
The FDA also issued a warning to healthcare providers and consumers regarding counterfeit Botox (botulinum toxin) discovered in several U.S. states. They urged consumers to obtain products from authorized sources and administered by trained, licensed professionals.
"FDA takes reports of counterfeit products seriously and is working closely with the Centers for Disease Control and Prevention (CDC), state health departments, and manufacturers to help protect the nation's drug supply," the FDA stated in a news release.
It is currently working with the Botox manufacturer AbbVie to identify, investigate, and remove suspected counterfeit products.
However, there is no current indication that the reported events were linked to AbbVie's FDA-approved Botox. So the genuine product should be considered safe and effective for its intended and approved uses, the FDA said.
The CDC urges people who consider taking Botox injections to find out if the Botox provider and setting such as a clinic or spa are licensed and trained to give the injection. This can be done using a license look-up tool provided by each state.
"Ask if the product is approved by the FDA and obtained from a reliable source. If in doubt, don't get the injection," the CDC cautioned.
The reported symptoms from botched Botox cases are similar to those seen when botulinum toxin spreads to other parts of the body, the FDA warned. The symptoms include blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness, and difficulty lifting the head after the injections.
Botulism, though rare, is a serious illness causing muscle weakness and, in extreme cases, death. It typically starts with muscle coordination issues in the eyes, face, mouth, and throat, extending to the neck, arms, torso, and legs, potentially causing breathing problems.
In case of any symptoms after the procedure, consumers are requested to seek immediate help from a healthcare professional or go to the emergency room.
Last week, the Illinois Department of Public Health reported two cases of illness with symptoms resembling botulism. The officials said they are investigating the case and suspect them to be linked to fake cosmetic injections administered by an unlicensed practitioner.