IRVINE, Calif. – Allergan Inc. (AGN), a maker of pharmaceutical products, on Monday said the Food and Drug Administration (search) filed an affidavit in a federal court that shows its Botox treatment played no role in the case of four patients who became ill after treatments by an unlicensed physician in Florida.
Botox, which is produced from botulinum toxin, is used in small quantities to treat neurological disorders as well to smooth wrinkles.
The Dec. 10 affidavit filed in Federal District Court in San Jose, Calif., states that the patients were given 20,000 units of unregulated, unlicensed and unapproved bulk botulinum toxin distributed by a Northern California maker of research material, the company said.
The health care provider then attempted to reconstitute the raw toxin and to inject it into himself and three patients as though it were an actual medical product, Allergan said. All four were admitted to medical centers with symptoms of botulism.
Based on these findings, the FDA's Office of Criminal Investigations applied for a search warrant for the maker of the raw toxin, and a federal search warrant was served on TRI-Toxin Research International (search) in Tucson, Ariz., which markets an unapproved and unlicensed botulinum toxin (search) allegedly only sold for research purposes and not for human use.
During the search, federal agents found materials advertising seminars held by TRI-Toxin staff suggesting medical uses on humans of unapproved and unlicensed botulinum toxin, as well as call lists and records containing the names and telephone numbers of dermatologists and plastic surgeons apparently targeted by TRI-Toxin, Allergan said.
''Botox is Allergan's unique brand of botulinum toxin type A and is the only product of its kind approved by the FDA for medical and aesthetic uses in the United States,'' executive vice president and general counsel Douglas S. Ingram said in a statement
Allergan shares rose 64 cents to $78.74 on the New York Stock Exchange.