In response to public reports suggesting a causal link between a BOTOX® Cosmetic treatment in 2003 and a fatality, Allergan, Inc. (NYSE:AGN) today provided further assurance to patients and the public about BOTOX® Cosmetic and BOTOX® (Botulinum Toxin Type A).
On January 23, Public Citizen, an advocacy group founded by Ralph Nader, filed a petition with the U.S. Food and Drug Administration (FDA) requesting labeling changes for botulinum toxins marketed in the United States. In media interviews today, a representative of Public Citizen appeared to suggest that BOTOX® Cosmetic caused the death of a single patient in 2004. This is untrue.
“Since its approval, over a million people have been treated with BOTOX® Cosmetic. In its entire history, there has never been a single reported death where a causal link to BOTOX® Cosmetic was established,” said Dr. Sef Kurstjens, Allergan’s Chief Medical Officer. “In a recent interview, a representative of Public Citizen appeared to suggest that there was a reported fatality associated with BOTOX® Cosmetic. A medical review of this actual case demonstrates that the patient passed away in the winter of 2004 from complications associated with staphylococcus pneumonia, not from a BOTOX® Cosmetic treatment the patient received 7 weeks earlier. This conclusion is consistent with the assessment of the treating physician.”
BOTOX® Cosmetic is approved in the United States for the aesthetic treatment of glabellar lines (the vertical lines between the brows). Additionally, under a separate label, BOTOX® has been approved for more than 18 years to treat serious medical conditions such as cervical dystonia, strabismus (crossed eyes), and blepharospasm (uncontrollable blinking). BOTOX® is often administered to patients who suffer from other chronic, debilitating neurological conditions who are at increased risk for mortality from underlying diseases, concomitant medications and other risk factors which themselves can cause serious adverse events. Nevertheless, reported serious adverse events after therapeutic treatment of BOTOX® are rare.
In the United States, adverse event reports are reported into the FDA’s Adverse Event Reporting System (AERS) database. The AERS database is intended to encourage physicians to report any drug reaction; however, the report of the event does not by itself mean that the treatment caused the event, just that the event occurred after treatment with the drug. As the FDA cautions, “for any given report, there is no certainty that a suspected drug caused the reaction.”1 So, for instance, if Allergan is notified of an adverse event from any source, it is required to make an “adverse event report” to the FDA even if Allergan or the physician has not established that BOTOX® caused the event and, indeed, even if the treating physician has affirmatively concluded that BOTOX® was not the cause of the event.
In its petition, Public Citizen cites adverse event reports culled from the AERS database over a 10-year period from 1997 through 2006. A representative for Public Citizen stated in press interviews that there is a definite causal relationship between BOTOX® and these adverse events. This conclusion, however, is contrary to Public Citizen’s own admission in its petition which explicitly states that “causality cannot be proved” with respect to these adverse event reports.2
“Our first priority is the safety and well being of the patients who use our products,” added Dr. Kurstjens. “In the last 18 years since BOTOX® was first approved by the FDA to treat rare eye disorders, Allergan has vigilantly monitored the use of the product and worked closely with the FDA to ensure that all appropriate warnings and guidance are in the product labels. We also work closely with the medical community to educate them on the safe administration of the product. And we proudly stand behind the more than 20 years of research that has supported the approval of 20 different indications for BOTOX® around the world.”
For any medical inquiries related to the proper use of BOTOX® Cosmetic or BOTOX®, please contact Allergan’s Medical Information Department at 1-800-433-8871.
Important BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) Information
BOTOX® is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.
BOTOX® is also indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.
The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane’s syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.
And BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
BOTOX® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18-65.
Important BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) Safety Information
BOTOX® and BOTOX® Cosmetic treatment should not be injected in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation.
Serious heart problems and serious allergic reactions have been reported rarely. If you think you’re having an allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking or breathing, call your doctor immediately. Individuals with peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX® or BOTOX® Cosmetic with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic side effects with BOTOX® or BOTOX® Cosmetic. For full prescribing information, please visit www.botox.com and www.botoxcosmetic.com.
BOTOX® for Blepharospasm in Patients ≥ 12 Years of Age: Reduced blinking from BOTOX® injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal perforation. The most frequently reported treatment-related adverse reactions in these patients are ptosis (20.8%), superficial punctate keratitis (6.3%) and eye dryness (6.3%).
BOTOX® for Strabismus in Patients ≥ 12 Years of Age: Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision or past pointing. The most commonly reported adverse effects are ptosis (16%) and vertical deviation (17%).
BOTOX® for Cervical Dystonia in Adults: There have been rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube. The most frequently reported adverse reactions in patients with cervical dystonia are dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).
BOTOX® for Severe Primary Axillary Hyperhidrosis Inadequately Managed with Topical Agents: The most frequently reported adverse events (3 - 10%) are injection site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.
BOTOX® Cosmetic for Temporary Improvement in the Appearance of Moderate to Severe Frown Lines Between the Brows in Adults 18-65: The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness and/or bleeding/bruising may be associated with the injection.
Forward-Looking Statements
This press release contains “forward-looking statements,” including statements regarding the safety, effectiveness and adverse events associated with BOTOX®.
These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry, biologic and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; inconsistency of treatment results among patients; potential difficulties in manufacturing; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2006 Form 10-K and Allergan's Form 10-Q for the quarter ended September 28, 2007.
About Allergan, Inc.
Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential – to see more clearly, move more freely, express themselves more fully. The Company employs more than 7,500 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.