Attack of the Killer Botox

WASHINGTON  — Health officials warned doctors and patients Thursday about potentially deadly risks of using the anti-wrinkle drug Botox and similar drugs for unapproved uses to treat certain types of muscle
spasms.

The Food and Drug Administration said Botox and two other injections carry risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

While Botox is best known for clearing wrinkles by paralyzing facial
muscles, the botulin-based drug also is widely used for muscle-spasm
conditions. In rare cases, the toxin can spread beyond the injection
site to other parts of the body, paralyzing or weakening the muscles
used for breathing and swallowing, a potentially fatal side effect.
Signs of botulism can appear just hours after injection and include
difficulty swallowing or breathing, slurred speech and muscle
weakness.

Manufacturers Allergan, Solstice Neurosciences and Medicis will have
to bolster warnings on their products and collect additional safety
data. The companies will also be legally required to distribute
medication pamphlets about the risks to patients.

The agency began investigating the problems last year at the behest of
Public Citizen, a consumer advocacy group.

Public Citizen’s Dr. Sidney Wolfe said the agency’s response was
appropriate, but he complained it came more than a year after his
group brought the problems to light.

“The response is mainly adequate but it is way too late for a lot of
people who have been injured or even died while taking these drugs,”
Wolfe said. “There’s no reason they had to wait this long.”

The FDA said it uncovered 225 cases of botulism related to the drugs
during its analysis and 17 deaths for which its analysis seemed to
suggest botulism as a cause. However, the agency said it was
impossible to definitively say the drug caused the deaths.

Most of the reports of hospitalization and death were in children with
cerebral palsy taking the drugs for spasticity in their legs. That use
is not approved in the U.S., though regulators said it is still
legitimate.

“These are patients who have a significant disability because of
spasticity and these products provide a very effective means to
relieve that significant problem,” said Acting Deputy Director Dr.
Ellis Unger. “We don’t want to discourage that use, but people need to
understand the risks involved.”

Unger said the agency’s review looked at reports stretching back to
1989, when Botox was first approved. He said it’s likely off-label use
of the drug has increased since then, though the agency does not track
prescribing patterns.

The majority of drug-related problems seen in adults came after
treatment for muscle spasms and cervical dystonia, a type of neck
contraction for which the drugs are approved. Some of those patients
had to be hospitalized and put on mechanical ventilation in order to
breath. While the agency said it has received reports of botulism
symptoms in patients taking the drug for anti-wrinkle uses, none of
those cases have been confirmed.

Unger noted that patients getting injections for cosmetic use receive
much smaller doses than those treated for spasms.

“You’re basically trying to relax the muscle, and the amount you need
depends on the size of the muscle,” Unger said, adding, “So a muscle
in the leg can be quite large and requires a fair amount of the
product.”

Botox and competitors Myobloc, from Solstice Neurosciences, and
Dysport, from Medicis, will carry a boxed warning, the most serious
type the agency enforces.

The new labeling urges physicians to tell patients about the risks of botulin-based drugs and to seek medical care if they develop any symptoms.

Irvine, Calif.-based Allergan said it would cooperate with the agency
and stressed that the problems reported by FDA are rare.