The FDA on Monday announced it is investigating
reports of children's deaths and severe side effects
for others treated for a variety of conditions with
the drug Botox and related products.
The agency
said it was reviewing the safety of Allergan's Botox
and Botox Cosmetic (botulinum toxin Type A) and
Solstice Neurosciences' Myobloc (botulinum toxin
Type B) after reports of the adverse reactions,
which included respiratory failure. The adverse
reactions may be due to overdosing, and there was no
indication they were related to defects in the
products, according to the FDA.
The agency is responding to a petition filed last
month by watchdog group Public Citizen, in which it
asked the FDA to place a black box warning—the
strictest warning—on these products.
Most of the children cited by the FDA were being
treated with botulinum toxin products to control
limb spasms caused by cerebral palsy. The agency
hasn't approved the use of the drugs for such
treatment, officials added.
The reactions appeared to be related to the
spread of the botulinum toxin to areas away from the
site of injection, and mimic symptoms of botulism
poisoning, which can include difficulty swallowing,
weakness, and breathing problems.
Currently, the drugs' label warns against using
these products in people with neuromuscular
disorders, Katz said.
FDA officials said Friday that they weren't
advising health care professionals to stop
prescribing these products. However, they are urging
physicians and their patients to watch for signs of
botulism poisoning.
The agency said it is reviewing the safety data
from clinical trials submitted by the makers of the
drugs. In addition, it is looking at "post-marketing
adverse event reports" and any published studies.
