Reports blame Florida botulism cases on misused toxin

Dec 15, 2004 (CIDRAP News) – Four Floridians suffering from botulism were injected with massive doses of a botulinum toxin that was not approved for use on humans, according to news reports based on court documents filed by the Food and Drug Administration (FDA)

A suspended physician working at a clinic in Oakland Park, Fla., injected himself and three other people with botulinum toxin that he had prepared as if it were Botox, a licensed drug, rather than the far more potent, raw toxin it was, according to reports by the Associated Press (AP) and the South Florida Sun-Sentinel in Fort Lauderdale. Botox is used to smooth facial wrinkles and treat certain muscle disorders.

The clinic, called Advanced Integrated Medical Center, had bought the toxin from List Biological Laboratories in Campbell, Calif., according to the reports. The FDA gave details of the case in an application to a federal court for a warrant to search List Biological.

The FDA said the company's botulinum toxin is not licensed or legally salable for human use, the AP reported. FDA agents searched the business Dec 9.

Allergan Inc., manufacturer of Botox, estimated that the vial of toxin ordered by the Florida clinic might have contained as much as 10 million units, as compared with 100 units of botulinum toxin in a vial of Botox, the company said in a Dec 13 statement. One hundred units of the toxin amounts to only "billionths of a gram," the company said.

The four patients received injections to treat wrinkles at the Florida Clinic Nov 23 and 24 and fell ill a few days later, according to the latest reports. Early suspicions had fallen on Botox as a possible cause of the illnesses.

Allergan's executive vice president and general counsel, Douglas Ingram, said the FDA document confirmed the company's conclusion that Botox played no role in the cases and is a safe product.

Yesterday's Sun-Sentinel report said the four patients were "virtually paralyzed in critical but stable condition." The patients have been identified as Bach McComb and Alma "AJ" Hall, hospitalized in Bayonne, N.J.; and Eric and Bonnie Kaplan, hospitalized in Palm Beach Gardens, Fla.

McComb is an osteopathic physician whose Florida license was suspended in 2003 because of allegations that he prescribed excessive amounts of painkillers, according to the AP.

As reported by the Sun-Sentinel, the FDA document said that McComb asked a clinic worker named Thomas M. Toia to order a vial of botulinum toxin from List. Toia told federal agents that List personnel who took his order asked only his name, address, and billing information.

The toxin is shipped as a powder and is mixed with saline solution before use, the report said. Toia said that when the vial arrived Nov 23, McComb began mixing it with 10 milliliters of saline, as he would have done for a standard vial of Botox. Toia told agents he estimated that the vial was equal to 20,000 units of Botox and warned McComb to dilute it with much more saline.

But McComb brushed off the warning, the report said. He injected himself and Hall with the preparation the same day and injected the Kaplans the next day.

The Sun-Sentinel quoted "Botox experts" as saying a fatal dose of Botox would be 3,000 to 5,000 units.

Federal and state agents had previously reported they were investigating whether the Florida clinic had bought unlicensed botulinum toxin products from Toxin Research International in Tucson, Ariz., which sells a toxin labeled for use only in animal research, according to the Sun-Sentinel. Agents said they found that the Tucson company buys its toxin from List, the newspaper said.

The FDA investigators said in the court documents that they had found evidence that Toxin Research was promoting its toxin to cosmetic surgeons for use on people, the newspaper reported.

Botulinum toxin is made by the bacteria Clostridium botulinum, which is widespread in the environment. The bacteria themselves (and their spores) are harmless, but the toxin is considered the most lethal known poison. It binds to nerve endings where they join muscles, leading to weakness or paralysis. Recovery from botulism occurs when the nerves grow new endings, which can take months, according to the FDA.

Botulism cases are commonly linked to contaminated food, especially improperly home-canned food. Babies can contract botulism by ingesting food containing C botulinum spores, which may germinate and grow in a baby's colon because the intestinal bacteria in infants are not fully developed, according to the FDA.

See also:

Dec 13 Allergan news release
http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=150344

CIDRAP overview of botulism

FDA Consumer article on botulinum toxin
http://www.fda.gov/fdac/features/095_bot.html

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