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In a recently released public statement, the U.S. Food and Drug Administration said it was reviewing the safety of Botox and Botox Cosmetic (botulinum toxin type A), and Myobloc (botulinum toxin type B). This action is being taken due to reports of adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
Botox works by using botulinum toxin, which blocks nerve impulses to muscles, causing them to relax. It was approved by the FDA in 2002 for use in improving the appearance of moderate to severe frown lines between the eyebrows. The agency also approved Botox for use in treating cervical dystonia (rigid neck muscle). The drug is also used “off-label” to treat severe underarm sweating, known as primary axillary hyperhidrosis, and pain. Myobloc is approved only for neck conditions.
The FDA said that the adverse reactions might be due to overdosing and there was no indication they were related to defects in the product. The adverse reactions mimic symptoms of botulism, which may lead to difficulty swallowing, weakness, and breathing problems. Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the Center for Drug Evaluation and Research, said, “We have become aware of a number of reports of serious adverse reactions related to the use of botulinum toxin products. These are reactions that involve parts of the body physically distant from the site of injection.”
The most severe adverse reactions were found in children being treated for spasticity in their limbs caused by cerebral palsy, which the FDA says is not an approved use of botulinum toxins in either adults or children.
Katz said that it is unlikely that the drugs were responsible for the cases of severe illnesses developed in some patients, and that in most cases the injections were used for non-neuromuscular disorders, which is the possible reason for triggering side effects.
While Katz would not reveal the number of deaths or adverse events associated with the products, a petition filed by the Public Citizen Health Research Group does. In a recent statement, Sidney Wolfe, director of the organization, said, “Our analysis of FDA data found that, between Nov. 1, 1997 and Dec. 31, 2006, the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections.” Of these 180 reactions were 16 deaths, four of them children under the age of 18.
The Public Citizen Health Research Group has petitioned the FDA to begin an investigation and has asked for a black box warning, the strictest warning, to be placed on Botox and Myobloc. Currently, the FDA isn’t advising health-care professionals to stop prescribing these products. They are, however, urging doctors and their patients to watch for signs of botulism poisoning.
The FDA says it is reviewing the safety data from clinical studies submitted by the manufacturers of the drugs, as well as “post-marketing adverse event reports” and any published studies. The FDA says that after completing their review, they will communicate to the public its conclusions, resulting recommendations, and any regulatory actions.
The Public Citizen’s Health Research Group said the FDA should follow the lead of European drug regulators who have already issued warnings about the dangers of using botulinum toxin. “Nobody should be dying from injected botulinum toxin. Educating physicians and patients about what adverse symptoms to look for and when to seek immediate medical attention will save lives," said Director Wolfe.
In a recent statement, the manufacturers of Myobloc said “safety of patients treated with Myobloc Injectable solution has always been of primary importance” for the company. “We support education and training of physicians in a number of ways regarding the proper use of this product as outlined in the prescribing information.”
Botox and Botox Cosmetic are manufactured by Allergan Inc., Myobloc by Solstice Neurosciences Inc.
