Botox Safety Label Updated for Serious Side Effects, Health Canada SaidJan 14, 2009 | Parker Waichman LLP, LLP
Health Canada has announced that the label for Botox Cosmetic Products sold in that country will be updated to include new safety warnings. The warnings will now include the risk of the toxin spreading to other distant parts of the body. Possible symptoms of "distant toxin spread," which can be fatal, include muscle weakness, swallowing difficulties, pneumonia, speech disorders and breathing problems, Health Canada said.
Botox and Botox Cosmetic, manufactured by Allergan Inc., is the only botulinum toxin products marketed in Canada. Botox is indicated for the treatment of muscle spasms in the neck, eye and foot, muscle pain, and excessive sweating. Botox Cosmetic is indicated for cosmetic purposes, to treat facial wrinkling.
In October, Health Canada said that five Canadians have died following Botox injections, prompting it to launch an investigation. At the time, Health Canada said it was also looking into eight reports of serious reactions following Botox treatment. The Botox reactions reported in Canada included throat swelling, respiratory arrest, difficulty swallowing and aspiration pneumonia, and infection that occurs when food or liquids are inhaled into the respiratory tract and lungs.
According to Health Canada, only one of the 13 reports it had received as of March 28 involved using Botox for wrinkles, and none was medically confirmed as “distant toxin spread.” However, “10 of the 13 cases were deemed to be serious owing to life-threatening reaction (one case), hospitalization (three cases), ongoing disability (one case) or fatal outcome (five cases),” the agency said in its most recent adverse reaction newsletter.
Two deaths occurred in children with cerebral palsy. As is the case in the U.S., Botox has not been approved for such use in Canada. The other deaths involved three women in their 60s, all of whom had underlying medical conditions such as Parkinson’s or cerebral palsy.
In addition to announcing the new labeling, Health Canada has advised Canadians using Botox and Botox Cosmetic products to seek immediate medical care if swallowing, speech or breathing disorders arise. Canadians with a history of underlying neurological disorders, swallowing difficulties and/or breathing problems should use these products with extreme caution. Botox and Botox Cosmetic products should only be used under specialist supervision in those patients and should only be used if the benefit of treatment is considered to outweigh the risk, Health Canada said.
Last February, the U.S. Food & Drug Administration (FDA) launched its own investigation of botulinum toxin injections, including Botox, Botox Cosmetic, and Mylobloc. In the U.S., Botox is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Mylobloc is approved for the treatment of adults with cervical dystonia.
The FDA said at the time that it had received reports of adverse reactions in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may have been due to overdosing.
Last month, we reported that Australian health regulators revealed that a mother treated with another botulinum toxin Type A product gave birth to a baby with severe birth defects. The drug implicated in that incident is called Dysport, which while not yet approved in the U.S., contains the same active ingredient found in Botox and Botox Cosmetic.