From Canwest News Service:Health Canada is investigating the deaths of five people who had been injected with Botox, and serious reactions in another eight cases.
All the deaths involved people who were treated for such medical conditions as neck and muscle spasms. Two occurred in children with cerebral palsy, including a nine-year-old boy given Botox for drooling - a condition for which the drug hasn't been approved.
The reactions suggest the botulinum toxin may have spread to other parts of the body beyond where it was injected, according to Health Canada.
Only one of the 13 reports Health Canada had received as of March 28 involved using Botox for wrinkles, and none was medically confirmed as "distant toxin spread," according to the agency's most recent adverse reaction newsletter.
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)."Adverse reactions 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.
The reports are based on suspicion only and could be due to an underlying illness or some other factor, Health Canada says.
Allergan Inc., the makers of Botox, says reported adverse reactions are rare and don't prove cause-and-effect.
"If you look at its entire 18-year history that the product has been on the market in Canada, and 20 years worldwide, serious adverse event reports have been rare with this product," said spokeswoman Caroline Van Hove. More than 14 million Botox vials for medical use have been distributed worldwide since the product was approved in 1989; another four million vials have been distributed for cosmetic use.
Health Canada announced an ongoing safety review of Botox in February following reports from the U.S. linking Botox and a similar drug, Myobloc, to adverse reactions, including respiratory failure and death.
The Canadian deaths included three women in their 60s, all of whom had underlying medical conditions such as Parkinson's or cerebral palsy. A 13-year-old boy with cerebral palsy and severe seizure disorder died after receiving Botox for muscle spasms.
Allergan is updating its product information to note rare reports of muscle weakness and other serious adverse events in children and adults, Van Hove said.
She said people treated with Botox for medical conditions such as muscle contractions receive far higher doses than a healthy adult would for wrinkling.
Consumer advocacy group Public Citizen has petitioned the U.S. Food and Drug Administration to issue warnings to doctors about the use of botulinum toxin products - available in the U.S. as Botox and Myobloc - including hospitalizations and deaths. The group wants a "black box" added to product labels and an information pamphlet given to patients when the drug is injected.
In Canada, Botox is approved for medical conditions such as uncontrollable muscle contractions, crossed eyes and excessive underarm sweating. Botox Cosmetic is approved for glabellar lines - the vertical lines between the eyebrows - forehead wrinkles and crow's feet.
But "nobody knows what happens when you go to another part of the body," said Dr. Sydney Wolfe, director of Public Citizen's Health Research Group. His group worries about the uses of Botox for unapproved applications, and at higher than approved doses.
Health Canada is asking doctors to report any adverse reactions suspected of being associated with Botox or Botox Cosmetic.
