Responding to reports mentioning BOTOX(R) in relation to a facility in Florida, Allergan, Inc. (NYSE:AGN) reported today that it is currently working with the appropriate state and federal public health authorities to investigate the matter. This isolated incident concerns patients treated with an unknown substance at one facility, Advanced Integrated Medical Center, in Fort Lauderdale, Florida. There are many facts that remain unknown, including which product or products have been used in these cases. Contrary to certain reports, authorities involved in the investigation notified Allergan today that they cannot confirm that BOTOX(R) was administered to these patients. Allergan is diligently investigating this matter to determine what substance may have been used by the facility.
Allergan has confirmed that in all of 2004, only two vials of BOTOX(R) were shipped to Advanced Integrated Medical Center and only one of which was shipped within the last 6 months. Allergan has reviewed all manufacturing and quality assurance processes involved with the vials and no deficiencies or irregularities were found. In addition, Allergan has reviewed all safety surveillance reports and found no medical adverse events from the manufacturing lots from which these two vials originated. Based on the company's investigation to date, we are confident in the worldwide safety and manufacturing quality of BOTOX(R) and BOTOX(R) Cosmetic.
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. It is one of the most widely researched medicines in the world with 20 approved indications in more than 70 countries and has treated millions of patients worldwide. Its proven 15-year efficacy and safety profile, which is supported by placebo-controlled clinical trials involving more than 10,000 patients, as well as open-label studies and extensive clinical practice involving millions of patients, demonstrates the benefits of this unique and versatile therapy.
Allergan encourages physicians and consumers with questions to call 1-800-890-4345 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.
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.