I posted earlier this week on the recent Botox® flap involving the advocacy group, Public Citizen, who is pushing the FDA to investigate deaths associated with Botox and to issue a black box warning against the drug. Yesterday the FDA announced that it is reviewing the safety of Botox and Myobloc (a competing botulinum drug).
Botox works by blocking the release of acetylcholine, a neurotransmitter, leading to relaxation of muscles. Severe adverse events can occur when the drug inadvertently affects muscles used for swallowing or breathing.
There have been serious events associated with Botox; all of these events have been in off-label use of Botox for neurologic or muscle disorders such as cerebral palsy or limb spasticity. Almost all of the serious events were in children. The doses ranged from 6.25 to 32 units per kilogram of bodyweight — that is the equivalent of 460 to 2,400 units for an adult — a huge dose. The approved dose of Botox for cosmetic purposes is 20 units.
In over a million people treated with Botox for cosmetic purposes, there has never been a death associated with the drug. In fact, when used for cosmetic purposes, there has only been one hospitalization, and it was not clear that this was even related to Botox.
Investigating the safety of drugs is what we pay the FDA to do; I just hope the public waits to hear the results of their findings before jumping to conclusions. Whatever you do, just don’t try to make your own homemade Botox from WikiHow.