The FDA hasn't hopped on Public Citizen's demand for a warning of safety problems with the commonly used wrinkle-fighter Botox. Health Canada, however, says it's reviewing safety information on the drug, approved in that country for cosmetic purposes and for treatment of muscle tics and stiffness.
The Canadian drug regulator says it started checking into safety data after some European studies indicated that the drug--botulinum toxin--might spread from the injection site and cause adverse reactions. "[A]fter a thorough review, Health Canada will take action, if necessary," the agency said.
Public Citizen wrote the FDA last week, asking for warnings about Botox and its sister drug Myobloc (made by Allergan and Solstice Neurosciences, respectively). The petition included information on hundreds of mild and severe reactions to the drugs, reported in Europe and the U.S.
- read the report [1] from The Canadian Press
- check out Public Citizen's petition [2] to the FDA
Links:
[1] http://ca.news.yahoo.com/s/capress/080129/health/health_health_botox_review
[2] http://www.citizen.org/publications/release.cfm?ID=7559