allegedly can lead to paralysis and death.
Botox and Myobloc Linked to Paralysis and Death
To date, the FDA has reported several deaths in children, mostly cerebral palsy patients who were administered Botox for associated limb spasticity (severe arm and leg muscle spasms). The FDA is currently investigating reports of illnesses in adults who used the drugs for other conditions, including a woman who was hospitalized after she was given Botox for forehead wrinkles.
The FDA warning came two weeks after being petitioned by Public Citizen to strengthen warnings to users of Botox and Myobloc. The advocacy group is asking the agency to order a black box warning after it cited 180 reports of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths. A black box warning is the FDA’s strongest type: it appears on the package insert for prescription drugs that may cause serious adverse effects. Public Citizen is also asking that every patient receive a pamphlet outlining the risk before each botulinum toxin injection.
Botox and Myobloc use botulinum toxin, which blocks nerve impulses to muscles. The FDA only approved the use of botulinum toxin for a limited number of “therapeutic” conditions, including uncontrollable neck and shoulder muscle contractions, crossed eyes, spasmodic blinking of the eyes and excessive underarm sweating. Use of botulinum toxins for treatment of limb spasticity in children or adults is not approved in the US, nor have botulinum toxins been approved in any condition in children less than 12 years of age.
Myobloc, made by Solstice Neurosciences Inc., was approved in December 2000 for the treatment of adults with cervical dystonia, a movement disorder that causes the muscles to contract and spasm involuntarily.
Botox, manufactured by Allergan, was first approved in December 1989 to treat blepharospasm (spasm of the eyelids) and strabismus (misaligned eyes or "cross-eyed"). In 2000, Botox was approved to treat cervical dystonia (severe neck muscle spasms). In July 20, 2004 it was approved to treat severe primary axillary hyperhydrosis (excess sweating).
The only approved cosmetic use is for temporary (up to 120 days) smoothing of wrinkles between the eyebrows. Most cosmetic uses of botulinum toxin are unapproved.
Currently, its label warns of the potential for botulinum toxin to spread beyond the injection site and that systemic adverse effects, including severe difficulty swallowing and difficulty breathing and even death, have occurred in patients with neuromuscular disorders such as myasthenia gravis.
But the FDA is now warning the public that the botulism toxin seems to be harming people who don't necessarily have neuromuscular diseases.
The agency has now asked Allergan Inc. and Solstice Neurosciences Inc. to provide additional safety records.
A Solstice spokesperson said that children with cerebral palsy receive far larger doses injected into their leg muscles than the doses given adults for cosmetic purposes. However, the FDA said the problems may be related to overdoses but it also has reports of side effects with a variety of doses.
Healthcare officials have not been advised to discontinue prescribing these products. The FDA is “considering, but has not reached a conclusion about whether this information warrants any regulatory action”. However, it has made the following recommendations to clinicians who administer Botox and/or Myobloc:
- Realize that potency determinations (units) vary among the botulinum toxin products and that clinical doses expressed in units are not comparable from one botulinum product to the next.
- Remain vigilant for systemic effects that may follow administration of botulinum toxins, including dysphagia, dysphonia, weakness, dyspnea, or respiratory distress. These symptoms, which are suggestive of botulism, have been reported from 1 day to several weeks after treatment.
- Inform patients and caregivers regarding how to recognize the signs and symptoms of systemic effects after being injected with a botulinum toxin. Advise patients to seek immediate medical attention for worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness.
Botox ArticlesU of C Study: Botox Spreads into Neighboring Tissue
Research conducted at the University of Calgary in Canada has found that Botox seems to have a mind of its own when injected into the body. This means that it is not as controllable as was previously thought because it spreads into tissues and muscles near the injection site.
Nadar's Public Citizen Seeking Black Box Warning for Botox News
Many are willing to go great lengths to achieve beauty, which even means gambling with their lives. With new evidence that Botox allegedly causes paralysis and even death in some of those who swear by the toxic boost, those who religiously receive the injections are said to be risking their lives to look good.
Botox: Risk of Injury and Death Tough to Swallow
Imagine drowning out of water. That's what aspiration pneumonia could feel like as a result of the migration of a Botox treatment into an area of the body it was never meant to treat. So far 16 deaths have been reported from the use of Botox.
FDA Renews Concerns Regarding Botox and Death
Botox: Lose the Wrinkles, Lose Your Life?
Botox Delivers Bad Results for Some Users
Botox In the NewsFEB-8-08: The FDA warms that patients receiving a botulinum toxin injection for any reason - cosmetic or medical - should seek immediate medical attention if they suffer any symptoms of botulism, including: difficulty swallowing or breathing, slurred speech, muscle weakness, or difficulty holding up their head. [CBS NEWS: BOTOX]
FEB-8-08: The FDA has launched a safety review into Allergan's Botox wrinkle reducer after reports of serious reactions in certain patients were received. [THE STREET: BOTOX]
JAN-25-08: Botox and a similar injected drug have been associated with 16 deaths, four of them in children, and scores of serious injuries. [NY TIMES: BOTOX DEATHS]
Botox Legal HelpIf you or a loved one has suffered paralysis or death as a result of Botox, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
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