Today the FDA issued an Early Communication about an ongoing study on the use of Botox. The communication was issued in response to a small amount of deaths and other severe side effects suggestive of botulism associated with the drug. Botox is commonly used to block nerve impulses allowing muscles to relax, therefore eliminating involuntary twitches and spasms. In recent years Botox has been used to relax muscles in the face in turn lessening the appearance of wrinkles, but the FDA warns that in rare cases the toxin may spread from the desired site resulting in respiratory paralysis and difficulty swallowing.
The deaths associated with the drug all occurred in children and predominately in those receiving Botox in an effort to control muscle spasms associated with cerebral palsy. However, the FDA has received reports of serious side effects in people of all ages and for many different conditions.
Friday’s warning came two weeks after the consumer advocacy group Public Citizen petitioned the FDA to strengthen warnings to users of Botox and Myobloc – citing 180 reports of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths.
The investigation into the side effects of Botox are in the early stages, but the FDA is encouraging doctors to inform patients receiving injections, for any reason, to seek immediate medical attention if they experience difficulty swallowing or breathing.