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Botox and Myobloc Linked to Paralysis and Death
The FDA has warned that the popular anti-wrinkle drugs Botox and Myobloc have been linked to adverse reactions, including respiratory failure and even death.
Several deaths in children, mostly cerebral palsy patients who were administered Botox for associated limb spasticity (severe arm and leg muscle spasms), have been reported.
| Botox: Personal Stories and Interviews |
Botox Injections Froze Model's Face--and Worse
 Nancy had four series of Botox injections between 2004 and 2005 but the fifth set would be her last. "This last time I had more injections that made my face feel frozen; I didn't want to tell people why, but my face was stuck in this scary expression," she says. And that's not the only side effect that Nancy endured...
[ MORE: BOTOX INJECTIONS]
"My Son was given 900 units of Botox and Never Spoke Again"
Sandra's son suffered a massive brain injury and he was given Botox to control muscle spasms in his arms and shoulders. But Sandra believes that the huge dose he was given (900 units) caused him to lose the ability to swallow; as well, she thinks this deadly toxin migrated to his brain.
[ MORE: BOTOX REACTION]
 "I want the World to know about Botox"
"I would like to get up and scream to the whole world about the terrible things that happened to me after my last series of Botox injections," says Eloise. "I want people to know that Botox is frightening." Unfortunately, Eloise can't get up too easily—she can barely lift her head.
[ MORE: BOTOX DISABLED]
Botox: "I Thought I Was Going to Die"
Like many patients, Rhonda D. says she was never told about the negatives of Botox, just the positives. However, she had a very bad reaction to Botox and still suffers from some of the side effects. Some patients who have experienced adverse reactions to Botox are considering a possible class action lawsuit against Allergan, the manufacturer, alleging they were not adequately warned about the risks.
[ MORE: BOTOX NEGATIVES]
"Botox Feel's Like You've Had a Stroke"
 When Alyssa S. went in for Botox injections, she had no idea that Botox could have serious side effects. Unfortunately, information is coming out that Botox causes some very troubling adverse reactions—including difficulty breathing and swallowing. Some patients are now investigating a possible lawsuit against the maker of Botox, alleging they were not adequately warned about the life-threatening side effects.
[ MORE: BOTOX STROKE]
A Close Call for Botox User
Susan was prescribed Botox injections to stop drooling. It has worked so far, but not without complications that have proved fatal to others. Unknown to her, the symptoms she took in stride were, in fact, early signs of poisoning by the botulinum toxin that constitutes Botox. And she suffered partial paralysis of her throat.
[ MORE: BOTOX CLOSE CALL]
Botox: Two Potentially Fatal Accounts
 Tanya was injected with Botox in September, 2006 for hyperhidrosis—a condition characterized by abnormally increased perspiration. "I just got the one shot and it was supposed to work for six months to control the excessive sweating in my underarms and hands," says Tanya. In 2006, little was known about its adverse side effects. Tanya did not read a quote on the FDA website, stating that Botox is "the most poisonous poison...it can be fatal when used improperly."
[ MORE: BOTOX FATAL]
Botox Caused Facial Paralysis
"I have one thing to say about Botox," says Richard Roe. "Don't use it." Roe was given a series of Botox injections for facial spasms but he wound up with the left side of his face paralyzed. "I couldn't even blink; I had to put eyedrops into my left eye to keep it moist and in order for me to sleep at night, I had to tape my eyelid shut."
[ MORE: BOTOX PARALYSIS]
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| Botox Risks |
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.
If you have received a botulinum toxin injection for any reason - cosmetic or medical – you should seek immediate care if you have suffered any symptoms of botulism, including: difficulty swallowing or breathing, slurred speech, muscle weakness, or difficulty holding up your head. And you may also wish to seek legal help.
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| More about Botox Paralysis and Death |
Botox and Myobloc Linked to Hospitalizations and Death
 The US Food and Drug Administration (FDA) today notified the public that Botox and Botox Cosmetic (botulinum toxin Type A), and Myobloc (botulinum toxin Type B) have been linked to adverse reactions, including respiratory failure and death.
[ MORE: BOTOX DEATH]
Botox: Lose the Wrinkles, Lose Your Life?
Got a Botox shot lately, to mitigate those wrinkles? Here's the thing—Botox could actually provide one little wrinkle of its own: You could die from it.
[ MORE: BOTOX WRINKLES]
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| Botox Press Releases |
 MAY-08-08: As new research continues to reveal that Botox, and Botox Cosmetic may not necessarily be the risk-free, never-give-it-a-second-thought cosmetic treatment that people eat up like candy, there are those who look beyond the potential dangers and even beyond the need.
[ MORE: BOTOX MIGRATION]
APR-25-08: As critics of Botox continue to lobby for black box warnings regarding the potential for the toxin to migrate away from injection sites to affect muscular function that could allegedly prove injurious or even fatal to a patient, the drug best known for its cosmetic indication is currently being studied for the potential treatment of headache.
[ MORE: BOTOX HEADACHE]
 APR-04-08: A new study has been conducted that says Botox may move from the face to the brain. The study that was published in the Journal of Neuroscience says that researchers injected Botox into the whisker muscles of rats. After the injection, the researchers then found that within three days there were remnants of a protein that is broken down by Botox in an area of the brainstem.
[ MORE: BOTOX SPREAD TO BRAIN]
MAR-31-08: The recent reporting of potential deaths and severe adverse reactions linked to Botox has served as somewhat of a primer to the general population as to what Botox really is.
[ MORE: BOTOX DEATH]
 MAR-27-08: Despite recent FDA warnings of proven paralysis and death from the popular product Botox, a fierce competitor brandishing a similar injectable toxin is on the horizon.
[ MORE: BOTOX COMPETITION]
MAR-23-08: Try to forget that the needle about to inject a substance in your brow is a derivative of a deadly bacterium.Try not to think about the fact that the same Botox used to paralyze the muscles that cause your crow's feet and furrowed brow, has also been known to migrate away from the injection area and can have the same numbing effect on muscles much more important to your survival than your laugh lines.
[ MORE: BOTOX TOXIN MIGRATION]
MAR-21-08: Are the FDA reports of Botox-caused death and paralysis enough to deter the millions who use the drug as a beauty tool? Let the numbers speak for themselves. Allergan, the manufacturer of Botox, posted a 24 percent leap in its profits in its 2007 fourth quarter alone. For 2008, they are targeting $1.37 billion of the cosmetic enhancement pie.
[ MORE: BOTOX DAMAGE]
MAR-15-08: Both Botox and the drug Myobloc have been linked with 16 deaths, in which four were children. There has also been 180 cases of adverse effects linked to the toxin which have occurred after the drug seeped into neighboring and very vital organs, according to the health advocacy group that calls itself Public Citizen.
[ MORE: BOTOX DEATHS]
 MAR-08-08: Dr. Arnold Klein, a world-renowned dermatologist is making it his mission to tell the public about the dangers of Botox, one of the most popular cosmetic treatments that almost everyone is familiar with in some form. Behind Viagra, Botox is the second-most popular prescription drug in the world and has served as a more cost-effective alternative to having cosmetic surgery.
[ MORE: BOTOX DANGERS]
MAR-05-08: In spite of a warning just a few weeks ago by the US Food and Drug Administration (FDA) concerning the safety of Botox, and a call by advocacy group Public Citizen for beefed-up warnings on product labels, Botox continues to be misunderstood.
[ MORE: BOTOX AND BOTULISM]
FEB-28-08: 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.
[ MORE: BOTOX CAN SPREAD]
FEB-26-08: 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.
[ MORE: BOTOX BLACK BOX]
FEB-25-08: 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.
[ MORE: BOTOX INJURY]
FEB-23-08: Recent concern over adverse effects, including deaths stemming from injections of Botox and Myobloc for both cosmetic uses and muscular conditions appear to carry much more weight in Europe, than it has in the US.
[ MORE: BOTOX BREATHLESS]
FEB-21-08: The FDA is now renewing their concerns regarding the risk of death and other health issues that can arise as a result of using Botox. This renewed concern comes after the group Public Citizen, based out of Washington, asked the FDA to place the strongest possible black box warning on the Allergan company's very popular anti-aging product.
[ MORE: BOTOX RENEWED CONCERN]
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| Botox the News |
FEB-8-08: The FDA warns 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]
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Botox Legal Help
If 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.
Posted on Feb-12-08
Updated on May-12-08
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