Health Canada, the agency charged with protecting and maintaining Canada’s public health, is investigating 5 deaths associated with the use of Botox to treat neck and muscle spasms. The investigation includes two children with Cerebral Palsy who died after receiving the drug. Eight other serious adverse reactions are also being investigated. The agency indicates that a likely cause of these reactions is the spread of the drug’s botulinim toxin to other parts of the patient’s body following injection.
Botulinum toxin type A, a nerve toxin contained (in minute quantities) in Botox, is one of the most poisonous naturally occurring substances and it is the most toxic protein in the world. Exposure to the toxin in significant quantities can cause Botulism, which results in severe muscle paralysis. The drug commonly known for its cosmetic use is also widely prescribed for medical purposes. Many children with Cerebral Palsy receive Botox injections to treat the symptoms associated with the disorder. While some researchers laud the drug’s effectiveness in children with Cerebral Palsy, claiming that it enhances the benefits gained from occupational therapy, others warn that any benefits may be too subtle for the patient’s family to notice with any significance.
Although the FDA has not approved Botox for the treatment of Cerebral Palsy or other spastic disorders, many physicians in the U.S. continue to prescribe the drug “off-label.” In February, 2008, the FDA issued a public health warning announcing that Botox had “been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses,” and it indicated that most of the severe side effects were reported among children with cerebral palsy.
In July, 2008, a California lawsuit was filed against Alergan, Inc., the manufacturer of Botox, on behalf of people who experienced adverse reactions to the drug, including serious injuries and death. The suit alleges that the Alergan violated federal regulations by marketing the drug for unapproved, or “off-label” use.
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