Counterfeit Botox injections linked to illness, hospitalization in two states

CNN
—

People in at least two states have been hospitalized with botulism-like illness after receiving cosmetic injections — commonly called “botox” — administered in a non-medical setting.

“Cosmetic injections must be an FDA-approved product, administered by approved providers and in approved facilities,” the U.S. Centers for Disease Control and Prevention said in a statement. “The sources of these botulinum toxin products are unknown or unverified at this time.”

However, an ongoing investigation involving the CDC, the U.S. Food and Drug Administration and several states “suggests that the product administered was counterfeit,” the Tennessee Department of Health said in a statement Friday.

Four cases have been reported in Tennessee, two of which required hospitalization. Two Illinois patients were also hospitalized.

Botulism is a rare but serious disease caused by toxins released by bacteria that attack the nervous system. Symptoms may include blurred or double vision, drooping eyelids, difficulty breathing, fatigue, slurred speech, or hoarse voice. Muscle paralysis can progress within hours or days if left untreated and can be fatal.

The bacteria Clostridium botulinum is an ingredient in Botox and similar cosmetic substances, according to the Illinois Department of Public Health. The purified form of botulinum toxin is approved by the FDA for use by licensed healthcare providers as a cosmetic treatment, they said in a press release issued Monday.

Laboratory-confirmed cases of systemic botulism after cosmetic or therapeutic botulinum toxin injections are rare, the CDC said.

However, the two Illinois patients received injections from a La Salle County nurse who was licensed but “performing work outside of her authority.” Tennessee also raised concerns about injections “administered in non-medical settings such as homes or cosmetic spas.”

“Illinois residents should exercise caution when considering cosmetic treatment,” Dr. Sameer Vohra, director of the Illinois Department of Health, said in a statement. “Receiving these treatments in unlicensed and unapproved settings may put you or your loved ones at serious risk of health problems. Please only seek cosmetic services under the supervision of licensed professionals trained to perform these procedures and who use FDA-approved products. If you experience any health concerns after a recent cosmetic treatment, please contact your healthcare professional immediately for help and assistance.

CNN also contacted the FDA, but the agency does not comment on investigations.