Allergan, Inc. (NYSE:AGN) continues to work with the appropriate state and federal public health authorities to investigate the isolated incident concerning patients treated with unknown substances at one specific facility, Advanced Integrated Medical Center, in Fort Lauderdale, Florida.
The authorities have not yet determined if these patients are suffering from botulism and if BOTOX(R) (botulinum toxin type A) was administered to these patients.
Authorities involved in the investigation have not indicated that lots of BOTOX(R) or BOTOX(R) Cosmetic are the focus of their investigation. Rather, the investigation is directed to inappropriate and unlicensed practices at the facility. In addition, Allergan has completed an exhaustive review of its manufacturing and safety processes and, based upon the company's investigation, the company is confident in the worldwide safety and manufacturing quality of BOTOX(R) and BOTOX(R) Cosmetic. Physicians and patients should continue to feel confident in administering and using BOTOX(R) and BOTOX(R) Cosmetic.
Multiple agencies are involved in a potential criminal investigation at the Advanced Integrated Medical Center where the patients received unspecified treatments. Unidentified and unlabeled substances were reportedly discovered at the medical center and the patients may have been given a cocktail of unknown compounds intravenously.
BOTOX(R) is a medical product containing tiny amounts (only a few billionths of a gram) of the highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX(R) has been approved by regulatory authorities in more than 70 countries for 20 different indications. Over the last 15 years, BOTOX(R) has been used to treat millions of patients worldwide who suffer from a variety of medical conditions. The same product was approved as BOTOX(R) Cosmetic in 2002 in the United States.
Allergan encourages physicians and consumers with questions to call 1-800-433-8871 to speak to a company representative. Allergan also encourages both physicians and consumers to visit its web sites at www.Allergan.com, www.BOTOX.com and www.BOTOXCosmetic.com to learn more about BOTOX(R) and BOTOX(R) Cosmetic. Consumers seeking a qualified injector for cosmetic applications can find a trained physician on www.BOTOXCosmetic.com.
About Allergan, Inc.
Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.