In response to public reports suggesting a causal link between a BOTOX(R) Cosmetic treatment in 2003 and a fatality, Allergan, Inc. (NYSE:AGN) provided further assurance to patients and the public about BOTOX(R) Cosmetic and BOTOX(R) (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(R) 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(R) Cosmetic. In its entire history, there has never been a single reported death where a causal link to BOTOX(R) 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(R) 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(R) Cosmetic treatment the patient received 7 weeks earlier. This conclusion is consistent with the assessment of the treating physician.”
BOTOX(R) 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(R) 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(R) 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(R) 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(R) caused the event and, indeed, even if the treating physician has affirmatively concluded that BOTOX(R) 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(R) 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(R) 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(R) around the world.”
Source: Allergan, USA