Allergan's Botox not involved in Fla. poisonings

January 1, 2005

National report - California pharmaceutical manufacturer Allergan is taking steps to reassure doctors and patients about the safety of Botox after four people became critically ill after they were treated with an unapproved raw botulinum toxin.

National report - California pharmaceutical manufacturer Allergan is taking steps to reassure doctors and patients about the safety of Botox after four people became critically ill after they were treated with an unapproved raw botulinum toxin.

At press time the four - an unlicensed South Florida doctor, his girlfriend, and a Palm Beach Gardens chiropractor and his wife - remained hospitalized with botulism poisoning, virtually paralyzed and on ventilators, according to news reports. Investigators believe the doctor - whose license was previously suspended on a charge of overprescribing painkillers - injected himself and the others with an illegal anti-wrinkle treatment at an Oakland Park (Fla.) clinic in late November.

Victims of botulism poisoning can be paralyzed for weeks or even months.

Allergan's Botox is currently the only botulinum toxin type A medical product approved by the FDA for use in the United States. Ms. Van Hove says the company reviewed all manufacturing and quality assurance processes following the Florida incident and found "no deficiencies or irregularity."

Allergan estimates the unapproved vial of toxin used in the Florida incident may have contained as much as 10 million units of botulinum toxin. For comparison, a vial of Botox contains only 100 units.

Knockoff? Investigators in the Florida incident seized evidence and were trying to determine if Tucson-based Toxin Research International intentionally sold an unlicensed Botox knockoff to doctors for use on humans, according to the Tucson Citizen. Investigators also searched a toxin factory, List Biological Laboratories, outside San José, according to news reports.

The hospitalized Palm Beach Gardens couple also has filed a lawsuit against the doctor, the clinic and the two toxin suppliers, according to news reports.

Allergan sells only to licensed healthcare professionals, and has a sophisticated tracking system in place to ensure that Botox is shipped on dry ice directly to the practitioner, Ms. Van Hove says. A holographic film also appears on each vial of Botox so that physicians and patients can be sure they have received authentic product, she says.

Physicians or patients with concerns about a product may speak with an Allergan representative by calling (800) 433-8871.

Continuing treatments Meanwhile, doctors say Botox users across the country continue to seek treatments.

"I have had some people ask me about the poisonings, but I haven't noticed any undue fear - or that people were canceling," says Jeffrey M. Hartog, M.D., a general plastic surgeon in Winter Park, Fla. "I'm sure I get the flyers about the Botox knockoffs and 'make-your-own' fillers - but I'm sure they go right in the trash. Anyone who uses them is playing with fire, and they are physicians who probably shouldn't be doing injections anyway."

Tamara K. Ehlert, M.D., a facial plastic surgeon and clinical instructor at Washington University in St. Louis, says "quite a few" patients asked her about the poisonings as she was administering Botox to them.

"It was more in the form of 'What do you think it was?'" she says. "They were not in the least concerned about what I was using because they know how conservative I am, and that I would not use anything that was not FDA-approved."