At the end of the article, hear what the owner of Soderstrom Dermatology Center in Peoria, Il has to say about the federal warning.
The popular anti-wrinkle drug Botox and a competitor have been linked to dangerous botulism symptoms in some users, cases so bad that a few children given the drugs for muscle spasms have died, the government warns.
Botox contains botulinum toxin, which blocks nerve impulses to muscles, causing them to relax. The Food and Drug Administration's warning includes both Botox, a wrinkle-specific version called Botox Cosmetic, and its competitor, Myobloc, drugs that all use botulinum toxin to block nerve impulses, causing them to relax.
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, the FDA said.
The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some other countries have.
However, the FDA warned that it also is probing reports of illnesses in people of all ages who used the drugs for a variety of conditions, including at least one hospitalization of a woman given Botox for forehead wrinkles.
The FDA wouldn't say exactly how many reports it is probing.
"We're not talking hundreds. It's a relative handful," said Dr. Russell Katz, FDA's neurology chief.
But the agency warned that patients receiving a botulinum toxin injection for any reason -- cosmetic or medical -- should be told to seek immediate care if they suffer symptoms of botulism, including:
- difficulty swallowing or breathing
- slurred speech, muscle weakness,
- difficulty holding up their head.
The 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.
While the FDA said the problems may be related to overdoses, it also has reports of side effects with a variety of doses.
Public Citizen's Dr. Sidney Wolfe criticized FDA's warning as falling short. He asked that the agency order a black-box warning, the FDA's strongest type, be put on the drugs' labels and require that every patient receive a pamphlet outlining the risk before each injection.
"Every doctor needs to notified about this, every patient needs to be notified," Wolfe said. "Children are showing the way, unfortunately some dead children."
He said drug regulators in Britain and Germany last year required that sterner warnings be sent to every doctor in those countries.
Dr. Carl Soderstrom at Soderstrom Dermotology Center in Peoria, Illinois said the current warning for botox for cosmetic use are sufficient, but “in the judgement of the FDA further labeling for Botox use in children with spastic diseases is warranted, it should be done. For cosmetic use I believe the warnings are more than adequate and the current warnings have served us and our patients well. “ He said the treatment of Botox for children with spastic diseases uses much higher doses than those used for cosmetic treatments.
Dr. Soderstrom said he isn't aware of any patients having a negative result from cosemtic botox procedures at his office and he has been offering the wrinkle reducing procedure since it was first available several years ago.
Soderstrom Dermatology Center uses botox for one other reason besides wrinkles: post herpetic pain in some hyperhidrosis patients, or people who has excessive sweating. He said those patients say it's very helpful.
Dr. Soderstrom said both the American Society of Dermatological Surgeons and the American Society of Plastic Surgeons support the current labeling of all Botox® products, and believe that the current data supports the continued safe use of this product with no change in labeling necessary.
Here is a list of the possible side effects of Botox when used for cosmetic reasons:
- A rare syndrome of migraine headaches
- Weight loss and disability, that is unproven, but may be related in unusual circumstances to Botox®;
- Temporary paralysis of other nearby muscles resulting in temporary loss of function (eg drooping eyelid, difficulty closing the eye);
- Headache, local numbness, rash and bruising.