WASHINGTON (AP) -- 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 warned Friday.
art.botox.gi.jpg
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.
Botox is best known for minimizing wrinkles by paralyzing facial muscles -- but botulinum toxin also is widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.
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.
Don't Miss
* Allergan stock dives on Botox warning
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, or difficulty holding up their head.
"I think people should be aware there's a potential for this to happen," Katz said. "People should be on the lookout for it."
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.
Nor is it the first warning. The drugs' labels do warn about the potential for botulinum toxin to spread beyond the injection site and occasionally kill, but the warnings link that side effect to patients with neuromuscular diseases.
That's what's different about these latest cases, said FDA's Katz: The botulism toxin seems to be harming people who don't have that risk factor of a neuromuscular disease.
Health Library
* MayoClinic.com: Botulinum Toxin Type A (Intramuscular Route)
Still, the FDA cautioned that its investigation is in early stages. It has asked Botox maker Allergan Inc. and Myobloc maker Solstice Neurosciences Inc. to provide additional safety records.
Allergan spokeswoman Caroline Van Hove said children with cerebral palsy receive far larger doses injected into their leg muscles than the doses given adults seeking wrinkle care.
In a statement, Solstice said it supports FDA's inquiry but stressed that the agency hasn't concluded the drug poses any new risk.
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
Anyone that knows me and Audrianna Knows that Audrianna undewent Botox injections for her muscle tone in May of 07. They also know that exactly a week later Audrianna was hospitalized and this is why. exactly a week after geeting botox injections we were told that we would start to see good results that audriannas muscle tone would be a little more managable. Instead Audrianna went from A happy toddler playing in her sandbox to one who couldnt lift her head and as I was in the house with her afterwards whiel I called the dr She ended up not being able to get off the floor she was just lying there unabel to move She whined in frusteration so we were off yet again to the ER where even they had no idea what was going on so she was admitted to be monitored and hopefully we would have an answer because this was new to the ER Staff they were googling the Botox injections and symtoms and side effects they said that they believed teh botox injections some how got into her blood stream. The FDA ended up getting involved Audrianna was monitored for respatory failure she could barely even swallow food. We were monitored for a week and a half we then were re dmitted cause she caught rotavirus at the hospital. We have been since told first itw as a bad batch of botox then that it was the way she reacted to it. Thankfully a friend on A CP support group forum I frequent posted recently about the FDA Warning. I have since Audrianna's incident warned people about Botox and our experience we decided then and still refuse to get Botox injections on Audrianna ever again yes her tone is pretty bad but there are other ways tp fix that including the constant stretching of her mucles. We have decided to give oral baclofen a chance and we hope and pray that it will work for her. I do however want people to beaware of what can happen to anyone who undergoes botox injections it is a very scary thing
No comments:
Post a Comment