Possible botulism reported after cosmetic injections

Dec 1, 2004 (CIDRAP News) – Four people in Florida and New Jersey who might have been injected with the anti-wrinkle medication Botox are seriously ill with possible botulism, according to news services.

Botox contains minute amounts of botulinum toxin, which causes muscle paralysis and is the most lethal known substance. The toxin, derived from the bacterium Clostridium botulinum, is one of the six biological agents considered most likely to be used by terrorists. Botulism is usually associated with contaminated food, particularly improperly home-canned food. Botox is used to smooth facial wrinkles and to treat certain muscle disorders.

The Associated Press (AP) reported that a man and woman in their 50s were in critical condition at Palm Beach Gardens (Florida) Medical Center on Nov 28. Dr. Charles Schallop, a neurologist who treated the couple, said they had gone to a Fort Lauderdale clinic called Advanced Integrated Medical Center Nov 24 for Botox injections, according to the AP report.

Two other people were being treated at a hospital in New Jersey for possible botulism, the AP report said. Schallop said the Florida couple reported that the New Jersey patients were at the Florida clinic the same day they were there. Schallop said he suspected all four patients might have fallen ill because of contaminated doses of Botox or some other drug.

The South Florida Sun-Sentinel in Fort Lauderdale said all four patients were on mechanical ventilators. Today the newspaper reported that the two patients in Florida, whom it identified as Eric S. Kaplan and his wife, Bonnie, were in serious but stable condition.

The two patients in New Jersey were still connected to ventilators but were conscious and communicating through gestures, the newspaper, citing relatives of the patients, reported today. The stories identified the patients as Bach McComb and Alma "AJ" Hall, both employees at Advanced Integrated Medical Systems. They were hospitalized at Bayonne (N.J.) Medical Center.

Authorities have not confirmed that any of the patients had botulism. A Nov 30 report in the Sun-Sentinel said doctors at Palm Beach Gardens Medical Center were treating the two cases there as botulism. The Florida Department of Health (FDH) said it was expecting laboratory tests to clarify the diagnoses later this week, according to the story. Calls to the FDH for more information were not returned in time for this story.

The maker of Botox, Allergan Inc. of Irvine, Calif., said Nov 29 that authorities had not been able to confirm that Botox had been administered to the four patients. The company said it was cooperating with federal and state health officials to investigate the cases.

Allergan also said only two vials of Botox were shipped to Advanced Integrated Medical Center this year and only one was shipped in the past 6 months. The company reported it had reviewed all manufacturing and quality-assurance processes related to the vials and found no problems. Also, the firm said it had received no reports of adverse events related to the manufacturing lots from which the vials came.

The Centers for Disease Control and Prevention (CDC) was helping with the FDH investigation by conducting lab tests, CDC spokeswoman Christine Pearson told CIDRAP News yesterday.

The Sun-Sentinel reported that the Food and Drug Administration (FDA) was investigating exactly what the four patients were injected with and who administered the injections. The newspaper quoted investigators as saying they were considering the possibility that patients were injected with foreign-made imitations of Botox and Myoblock, another anti-wrinkle drug that contains botulinum toxin.

The newspaper described McComb as a physician whose license was suspended by Florida health officials in 2003 after he was charged with trafficking in addictive pain medications.

The New Jersey Department of Health and Senior Services issued a short statement Nov 29 saying that botulinum toxin poisoning had not been confirmed in the two patients. The statement said Florida health officials were taking the lead in investigating the cases and that New Jersey was cooperating with Florida and the CDC.

See also:

Nov 30 Allergan news release
http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=149490

CIDRAP overview of botulism

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