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Botox and Myobloc Linked to Paralysis and Death

On August 3, 2009 the FDA updated its safety alert to a Black Box Warning on the popular anti-wrinkle drugs Botox and Myobloc. All Botox product labels now warn that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms, which have mostly been seen in children with cerebral palsy who received injections off-label for treatment of muscle spasticity, include potentially life-threatening swallowing and breathing difficulties and even death.

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Black Box warnings have been added on four botulinum toxin drug products:
  • Botox (new established name: onabotulinumtoxinA)
  • Botox Cosmetic (new established name: onabotulinumtoxinA)
  • Myobloc (new established name: rimabotulinumtoxinB)
  • Dysport (abobotulinumtoxinA) was approved in April 2009 with the boxed warning and is not making any name or label changes at this time.
(On its website, The FDA explains that the established drug names--often referred to as the generic name--have been changed to help reduce the potential for dosing errors. Neither the brand names nor the formulations of the products have changed.)

botox dangerousBetween Nov. 1, 1997, and Dec. 31, 2006, the advocacy group Public Citizen reported that 658 people had adverse reactions to botulinum toxin. Of these, 180 people had difficulty swallowing or contracted aspiration pneumonia when food refluxed into the windpipe. Eighty-seven of those people had to be hospitalized and 16 died. All but one of the deaths were associated with therapeutic use.

The FDA was petitioned by Public Citizen to order a black box warning on all Botox products. (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 also requested that every patient receive a pamphlet outlining the risk before each botulinum toxin is administered.

The FDA issued a press release two weeks after the Public Citizen report, acknowledging safety concerns with the botulinum toxin products and revealing that the agency was conducting ongoing reviews of data from the drug companies as well as monitoring reports of adverse events related to the use of the products.

Botox Cerebral Palsy

Several deaths in children, mostly cerebral palsy patients who were administered Botox injections off-label for associated limb spasticity (severe arm and leg muscle spasms), have been reported. The use of these drugs off-label has not been approved by FDA. Although symptoms have also been reported in adults treated both for approved and unapproved uses, Cerebral palsy Botox treatments use much larger doses than cosmetic use of Botox and are applied to areas more likely to allow the toxin to spread to other parts of the body and thereby cause Botox problems.

Symptoms of Botox cerebral palsy treatment problems could include the following:
  • Weakness
  • Double or Blurred Vision
  • Drooping Eyelids
  • Slurred Speech
  • Dry Mouth
  • Difficulty Swallowing
  • Respiratory Distress
Botulinum toxin drug products

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. The only approved cosmetic use is for temporary (up to 120 days) smoothing of wrinkles or frown lines between the eyebrows at the recommended doses. Most cosmetic uses of botulinum toxin are unapproved.

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).

Botox and Myobloc still Available

Although Botox products now include a black box warning, healthcare officials have not advised discontinuing prescribing these products. However, the FDA 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 Warnings

The Botox label currently 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.

botox facial paralysisThe FDA is also warning the public that the botulism toxin seems to be harming people who don't necessarily have neuromuscular diseases. The agency has been 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 has asked Allergan Inc. and Solstice Neurosciences Inc., makers of the Botox and Myobloc injectables, 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. The FDA said the problems may be related to overdoses but it also has reports of side effects with a variety of doses.

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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BOTOX AND MYOBLOC LEGAL ARTICLES AND INTERVIEWS

Botox Approved for Migraine
Botox Approved for Migraine
October 16, 2010

On the heels Allergan Inc. pleading guilty to marketing its wrinkle smoother botox for unapproved uses, the Food and Drug Administration has now approved Allergan's product, which is a purified form of the poison botulinum, for chronic migraine headaches READ MORE


Attorney Ray Chester Is the Botox Buster
Attorney Ray Chester Is the Botox Buster
May 27, 2010
Austin, TX Attorney Ray Chester has given Allergan, the manufacturer of Botox, a few worry lines of its own. He recently obtained a $15 million verdict on behalf of an Oklahoma woman who suffered unintended consequences after receiving a Botox injection to eliminate wrinkles in her forehead. Chester has at least eight other suits pending against the company READ MORE

Indiana Couple Blames Botox for Death of Daughter
Indiana Couple Blames Botox for Death of Daughter
March 20, 2010
Indianapolis, IN The US Food and Drug Administration (FDA) has approved Botox injections for only a handful of indications, but off-label use continues on a wide scale. According to a proposed lawsuit in Indiana, off-label use of Botox for muscle spasms triggered the death of a 10-year-old girl with cerebral palsy READ MORE

READER COMMENTS

Posted by

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Been doing botox for years for chronic m igrains, have blurred vision, droopy lids, brain fog, weakness, severe fatigue, full body pain esp in neck , spine and hips. Leg weakness, been diagnosed with several auto immune diseases and put on disability at 47 yrs old , please contact me if this seems it could be effects of botox rather than autoimmune diseases ty

Posted by

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I’m having a lot of things happening to me since my injections. When I 1st went to the doctor I drove myself walked in with a cane drove myself back home and could go anywhere I wanted to go by myself. Now I can’t drive ,I have muscle weakness, to where I can’t even walk with a cane . I feel very tired all the time my hand I can’t use because it won’t open up for me. I have no control of my blatter .ihave many more problems to many to write. I m in a wheel chair and can’t dress myself, bathe without help, can’t cook for myself. I have a care giver to help me. Can’t get into a car by myself. Need help doing everything. The doctor injected Botox in my leg and arm. He used about 7 needles and poked my leg and arm about 28 times . I had the shot every 3 months, I knew I was going down but didn’t know why. I have more to explain but this is part of it. Thank you , I need some help .

Posted by

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I risked my health over my vanity because I didn't realize I would have these severe side effects, I got Botox injections in June 2016 and again in July and nearly died from severe bacterial pneumonia in October 2016. It was highly unresponsive to the strongest IV antibiotics that my body barely tolerated. I was hospitalized for nearly a week, couldn't tolerate the following two weeks of oral antibiotics with nearly every side effect and 3 different classifications types of antibiotics and the end result was going back to the hospital daily for another 6 days of IV infusions. Now I am having paralyzing and very painful muscle spasms in my hands and feet and muscle muscle weakness. I am left with severe anxiety and paranoia that I will get sick again. I am a brain cancer patient who was medically retired from the Air Force in 2004 with a reoccurrence in 2009. I am partially paralyzed on my left side. I feel their is some responsibility that falls on the clinic knowing or not knowing the risks associated with injecting me and they should have turned me away rather than encouraging my treatment and then innjecting me twice 6 weeks later because I wanted better results. I lost so much of my abilities with brain cancer I didn't want to lose my attractiveness also. I can't believe the clinic was reckless enough to push me into this knowing my history and helping physically onto the treatment table.

Posted by

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Painful bruising that I can STILL feel, papulpustular acne roscea(DOES NOT GO AWAY) and NO I DID NOT HAVE IT PRIOR TO THIS! AND WORST OF ALL UPPER CHEEK PARALYSIS THAT IS SO NUMB AT TIMES I CANT SEE PROPERLY!

Posted by

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Paralysis of the neck, no head control, damage to neck due to droopy head and cervical collar.

Posted by

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I was given Botox and my health has continued to decline. I have been diagnosed with COPD and I have never been a smoker. I was also diagnosed with Primary Pulmonary Hypertension since receiving the injection.

Posted by

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My daughter has had to have a G-tube put in place because she developed dysphagia from the botox injections. She has suffered with over all muscle weakness. She currently is suffering from nerve pain from the injections in her arm. She has to take medications to help control the pain. Our doctor denied in the beginning that the botox was not the source for these symptoms. She claimed that the "low" dose and location of injections would not cause the symptoms. Now we know better. She has finally stated, yes it is the botox that has caused the problems for my daughter.

Posted by

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The results of the injections were catastrophic for me. It was the worst thing that has ever happened to me physically in my life. I was in constant pain except while lying down and could not hold my head up while leaning forward or do everyday tasks without intense pain for 3 full months. I was unable to work or do most of my normal activities. It was horrible!

Posted by

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I have my own independent contractorship, and am not able to work, at all. I can work in moderate pain, but not this. The poisoning has depleted my energy, I'm extremely irritable, and can't think clearly. Some days I can't remember where I am (I've lived in my condo for 8 years), or how to "use" a car. ie, how do I get in? where does this key go?, and how do I get to the store? I went to grad school for 4 years, top of my class, but I can't make breakfast. I have lost the ability to sequence tasks, and am unable to communicate effectively. I have nothing to fall back on, and am paying for 2 insurance policies, recertifications, etc.

Posted by

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I have been diagnosed with severe migranes and my neurolgist "WAS" using Botox for treatment. I had numerous injection in my head neck and scalp. It did help a little in the frequency of headaches but now I am beginning to suffer terrible side-effects. I have severe pain running down the back left side of my neck and can't turn my head without wrenching pain. I do not have very much range of motion and it get worse daily. I have tried muscle relaxers, PT, massage, etc and nothing is helping. It has been 6 months since my last injection and I will not be subjecting myself ever again to it.

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