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Botox to Undergo Canadian Safety Review

Jan 30, 2008 | Parker Waichman LLP

Botox death reports have prompted Canadian regulatory authorities to take another look at the drug.  Health Canada is looking at the safety information on Botox, which is approved in Canada to fight wrinkles as well as for non-cosmetic purposes, including the treatment of spasticity or muscle stiffness.  "Health Canada's review of safety information on the issue of toxin spread regarding Botox began after departmental experts' review of European studies," Health Canada spokeswoman Carole Saindon said, adding that "Canadians can be confident that after a thorough review, Health Canada will take action, if necessary."

Botox made news last week when the lobby group Public Citizen wrote to the U.S. Food and Drug Administration (FDA) calling on it to "immediately require Allergan and Solstice Neurosciences to issue a warning letter to physicians regarding all formulations of botulinum toxin (Botox and Myobloc, respectively).  This letter would alert physicians to serious problems, including hospitalizations and deaths, resulting from the spread of the toxin from the site of injection to other parts of the body," they said.  Public Citizen's petition included an in-depth analysis of hundreds of mild and severely adverse reactions to Botox treatments, which have been reported since the late 1990s in both Europe and the U.S.

Allergan disputed claims that complications from Botox treatments have resulted in death.  In the U.S., consumer groups are demanding new black box warnings be included to Botox and Myobloc packaging to indicate the medications can cause death in some cases.

Health Canada said its primary concern is the health and safety of Canadians.  If the review identifies any new safety information, "it will be made public to Canadians and Canadian health care professionals as soon as it is available."

But recently, Botox has been linked to a number of hospitalizations and 16 deaths.  Of the deaths, four of the victims were children under the age of 16.  An additional 87 people were hospitalized.  All the deaths and injuries appear to be the result of the botulinum toxin spread inside the bodies of the patients.

Botox is best known for smoothing facial wrinkles but is medically approved for treating cervical dystonia, or rigid neck muscles and is also used to treat stroke victims and medical conditions including excessive sweating.  Myobloc is only approved for the neck condition.  Both injections are made with forms of the botulinum toxin, which blocks nerve impulses to muscles, relaxing them.  In children, Botox is used when neurological disorders are present, such as Cerebral Palsy.  Injections are meant to allow the child to gain normal movement by weakening stronger muscles and strengthening weaker ones by forcing the stronger contracting muscles to relax.  While experiencing the drug’s effects, physical therapists work with the child to develop the weaker muscles.  Although not appropriate for all children with CP, the treatment may help some move normally.

As well as deaths, there have been reported problems of muscle weakness and difficulty swallowing.  And American group Public Citizen says it has seen 180 reports sent to the FDA about Botox and Myobloc detailing cases of muscle weakness, difficulty swallowing, or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs.

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