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Counterfeit Botox injections linked to illness, hospitalization in two states

An image produced using optical microscopy shows Clostridium botulinum, an ingredient in Botox and similar cosmetic substances. The purified form of the botulinum toxin is approved by the FDA for use by licensed healthcare providers as a cosmetic treatment.
BSIP/Universal Images Group/Getty Images via CNN Newsource
An image produced using optical microscopy shows Clostridium botulinum, an ingredient in Botox and similar cosmetic substances. The purified form of the botulinum toxin is approved by the FDA for use by licensed healthcare providers as a cosmetic treatment.

By Deidre McPhillips, CNN

(CNN) — People in at least two states have been hospitalized with botulism-like illness after receiving cosmetic injections – commonly known as “botox” – that were administered in non-medical settings.

“Cosmetic injections should be an FDA-approved product, administered by licensed providers and in licensed settings,” the US 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, US Food and Drug Administration and multiple states “suggests that the product administered was counterfeit,” the Tennessee Department of Health said in a press release on Friday.

Four cases have been reported in Tennessee, including two that required hospitalization. Two patients in Illinois have also been hospitalized.

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

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

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

However, both patients in Illinois received injections from a nurse in La Salle County who was licensed but was “performing work outside 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,” said Dr. Sameer Vohra, director of the Illinois health department said in a statement. “Receiving these treatments in unlicensed, unapproved settings can put you or your loved ones at serious risk for health problems. Please only seek cosmetic services under the care of licensed professionals trained to do these procedures and who use FDA approved products.If you are experiencing any health problems after a recent cosmetic treatment, please contact your healthcare provider immediately for help and assistance.”

CNN also reached out to FDA, but the agency does not comment on investigations.

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