FDA Checks Reports of Botox Risks
Rare Cases of Deaths, Breathing Problems Possibly Linked to Botox, Botox Cosmetic, and Myobloc
By
Miranda Hitti
WebMD Health News
Reviewed By
Louise Chang, MD
Feb. 8, 2008 -- The FDA today announced that it's investigating rare reports of serious adverse events
linked with Botox, Botox Cosmetic, and Myobloc.
The most serious cases, in which
patients died or were hospitalized, occurred in children with cerebral palsy
who got botulinum toxin for severe arm and leg muscle spasms associated with
their cerebral palsy. That's an unapproved use of the drugs.
No adult deaths have been linked
to the drugs, but some adults have been hospitalized, including at least one
person who used Botox for cosmetic uses. It's not clear if that case was due to
Botox use. Adults' reported symptoms include difficulty holding up their heads,
weakness, difficulty swallowing, and droopy eyelids.
The FDA isn't halting the
drugs, but it is reviewing the products' labels.
The FDA advises patients and
caregivers to watch for possible side effects including weakness, difficulty
breathing, difficulty swallowing, and change in voice. Those effects have been
reported as early as one day and as late as several weeks after
treatment.
No Flaws Seen in Drugs
The three drugs -- Botox, Botox Cosmetic, and Myobloc -- contain tiny doses
of botulinum toxin.
Botox, which is approved to treat eyelid spasms, neck spasms, and excessive
sweating, contains botulinum toxin type A. So does Botox Cosmetic, which is
used to treat facial frown lines.
Myobloc, which is approved to treat neck muscle spasms (cervical dystonia)
in adults, contains botulinum toxin type B.
The reported cases involved
approved and unapproved uses of the drugs. The cases aren't believed to be due
to problems with the drugs.
There is "no reason to believe
it's related to bad Botox," Russell Katz, MD, said at a news
conference. Katz directs the neurology products division at the FDA's Center
for Drug Evaluation and Research.
The FDA doesn't yet have final
number of cases to report. So far, the FDA is aware of a
"relative handful" of cases -- less than 100 -- says
Katz.
He notes that although "very
few" cases involved the cosmetic use of Botox, such cases are possible
but would be "very unusual."
The watchdog group Public Citizen
is calling for a "black box" warning for botulinum toxin products.
Katz says that's "something to be considered, but it's still premature to
say anything definitive about that."
SOURCES: FDA: "Early Communication about an Ongoing Safety Review Botox and Botox
Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type
B)." Russell Katz, MD, Director,
Division of Neurology Products, Center for Drug Evaluation and Research,
FDA. News release, FDA. News release, Public Citizen.
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