Allergan Canada comments on the safety profile of its BOTOX(R) (Botulinum Toxin Type A) product

TORONTO, Jan. 30, 2008 (Canada NewsWire via COMTEX News Network) -- In response to reports suggesting a causal link between BOTOX(R) and fatalities, Allergan Canada provided further assurance to patients and the public in Canada about BOTOX(R) (Botulinum Toxin Type A). In its more than 18-year history since the product was first approved worldwide, reports of serious adverse events following BOTOX(R) injection have been rare and there has never been a single reported death where a causal link to BOTOX Cosmetic(R) was established. It is very important to recognize that BOTOX(R) is also often administered to patients who suffer from chronic, debilitating neurological conditions, such as children with juvenile cerebral palsy, who are at increased risk for mortality from underlying diseases, concomitant medications and other risk factors which themselves can cause serious adverse events. The product labeling for BOTOX(R) notes rare select cases of fatal outcomes in which some patients had significant debilitating conditions or may have had a history of cardiovascular disease or other co-morbid conditions. The BOTOX(R) labels specifically warn that patients with pre-existing neuromuscular disorders may be at increased risk of clinically significant systemic effects from typical doses of BOTOX(R). In Canada, adverse event reports are reported into Health Canada. It is important to understand that a report of an adverse reaction following treatment with a drug does not by itself mean that the drug caused the reaction, just that the event occurred after treatment with the drug. So, for instance, if Allergan Canada is notified of an adverse reaction from any source, it is required to make an "adverse reaction report" to Health Canada even if Allergan or the physician has not established that BOTOX(R) caused the event and, indeed, even if the treating physician has affirmatively concluded that BOTOX(R) was not the cause of the event. BOTOX Cosmetic(R) is approved in Canada for the treatment of upper facial rhytides and glabellar lines. Additionally, under a separate label, BOTOX(R) has been approved in Canada since 1990 to treat serious medical conditions such as strabismus (crossed eyes), blepharospasm (uncontrollable blinking), VII nerve disorders, including paralysis, weakness or abnormal movements of the face such as twitching or spasm; cervical dystonia, cerebral palsy, hyperhidrosis (excessive sweating) and focal spasticity, a motor disorder commonly seen in patients who have had a stroke or traumatic injury to the brain. 'Public Citizen,' a U.S.-based consumer group, has filed a petition with the U.S. Food and Drug Administration (FDA) suggesting additional label changes for all botulinum toxin products. It is important to note that the safety issues cited in the Public Citizen petition are not new for the Canadian medical community as they are already addressed in the Canadian product labelling for all botulinum toxins. About Allergan, Inc. With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company that discovers, develops and commercializes specialty pharmaceutical and medical device products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives. (R) Marks owned by Allergan, Inc. SOURCE: Allergan Inc. Kate Hanna, khanna@national.ca, (416) 848-1404 (B), (416) 567-3684 (C); Vanessa Eaton, veaton@environicspr.com, (416) 969-2713 (B)