The U.S. Food and Drug Administration warned that the anti-wrinkle drug Botox and a competitor Myobloc have been linked to several deaths and other severe side effects consistent with botulism.
Both drugs use botulism toxin to block nerve muscles causing them to relax however, in rare cases, the toxin may have spread to other parts of the body from the injection site. Resulting problems include paralysis of the respiratory muscles and difficulty breathing.
All reported child deaths were among children and most of whom were being treated for limb spasms associated with cerebral palsy. Other countries have approved the drugs' for this use but the FDA has not.
A spokesperson for Allergan Inc, maker of Botox, stated that children with cerebral palsy receive much larger doses into their leg muscles than what an adult seeking wrinkle care would receive.
The FDA has not gotten to the stage in its investigation where it would require a black-box warning, its strongest warning, but has stated that doctors should warn all patients receiving the treatment, for cosmetic or medical purposes to seek immediate care should they experience difficulty swallowing, slurred speech or muscle weakness.
[Source: FDA]
.jpg)
Comment Preview