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Botox manufacturers deny responsibility in poisonings

Ambulatory Safety Monitor, December 2, 2004

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In the wake of four people in Florida requiring hospitalization for suspected botulism poisoning, the manufacturer of the popular wrinkle-removing drug Botox is offering assurances to plastic surgeons and outpatient facilities that administer the drug that its product is safe.

According to an Associated Press wire story, Botox-makers Allergan Inc. of Irvine, CA reported selling only two vials of the drug this year to Advanced Integrated Medical Center in Oakland Park, FL. It was there that four patients-including two employees of the clinic-received injections of Botox, or a similar substance. An investigation is currently ongoing.

Allergan Inc. released a statement this week that read, in part, "Allergan has reviewed all manufacturing and quality assurance processes involved with the vials, and no deficiencies or irregularities were found. We are confident in the worldwide safety and manufacturing quality of Botox." Additionally, Allergan stated that it has received no reports of anyone getting sick from other vials contained in that batch.

The two clinic employees, who are hospitalized in New Jersey, are reportedly hooked up to breathing machines but able to communicate, while the two other patients are hospitalized in Palm Beach, FL, in serious but stable condition. While Botox use has become commonplace and casual enough that injections are now given at spas and even house parties, an improper dosage can lead to botulism poisoning, a potentially fatal illness that can paralyze muscles and the respiratory tract.

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