Botox Side Effect. Have you been injured by Botox? Our Botox injury lawyers are investigating reports of serious and life-threatening complications linked to Botox when botulinum toxin spreads beyond the injection site, especially in instances where it has been used off-label to treat conditions such as limb spasticity.
Lawsuits have already been filed around the country alleging Botox injuries, with some resulting in substantial settlements and judgments.
Allergan, the maker of the multibillion dollar drug, has been aware of the possibility of spread of the toxin from the injection site and the potential catastrophic consequences for years. If you or a loved one suffered a Botox injury, you may be eligible to receive compensation for your medical bills, lost wages, pain and suffering, and other damages.
Our Botox injury lawyers are offing free lawsuit evaluations to victims this drug. We urge you to contact our Botox injury lawyers as soon as possible to protect your legal rights.
Botox Side Effects
Allergan markets two varieties of Botox. Botox, which is made with botulinum toxin type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).
Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines.
Botox is also used off-label to treat a number of conditions, including cerebral palsy in children, which can be associated with stiff, jerky and difficult movements caused by muscles that are in a constant state of tension. The botulinum toxin can prevent muscles from contracting in such patients.
Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. However, doctors are permitted to use approved drugs in anyway they see fit, though drug makers are legally barred from promoting such use.
In April 2009, the U.S. Food & Drug Administration (FDA) mandated a black box label for Botox and similar products that warned of the risk of adverse events when the effects of a botulinum toxin injection spreads beyond the site where it was injected.
The label revision followed an FDA safety review prompted by reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity.
This complication presents similar to botulism poisoning. Symptoms of these types of Botox reactions include:
- Double or Blurred Vision
- Drooping Eyelids
- Slurred Speech
- Dry Mouth
- Difficulty Swallowing
- Respiratory Distress
Botox Settlements and Verdicts
Botox injuries, and Allergan’s promotion of off-label use of the drug, have resulted in several significant settlements and judgments against the company. In the fall of 2010, Allergan agreed to plead guilty to federal charges that it misbranded Botox, and admitted that its marketing tactics led physicians to use Botox for unapproved uses such as headaches, pain and cerebral palsy in children from 2000 to 2005. As part of the settlement with the US Department of Justice, the company agreed to pay penalties of nearly $600 million.
Federal prosecutors launched the investigation into Allergan when two whistle blowers – a physician and a Botox sales representative – filed a complaint in Atlanta. The company was accused of making it “a top corporate priority to maximize sales of Botox for unapproved uses between 2000 and 2005, according to documents released by the Justice Department.
The tactics Allergan used included paying doctors to attend meetings promoting unlawful marketing and to lobby healthcare payers to cover off-label use of the drug. The company also spent $8 million on a purportedly independent, online neurotoxin education organization to “stimulate increased use of Botox.
In September 2010, Allergan also reportedly agreed to settle a Botox wrongful death lawsuit filed on behalf of a 70-year-old Texas woman who died in 2008 after receiving 100 units of Botox. Sondra Bryant had received the Botox injections to treat pain in her shoulder. Bryant’s family claimed she was not told about the potential side effects of Botox use before she was injected.
Bryant was unable to hold her head up without support
According to her family’s lawsuit, within a few days of receiving her Botox shots, Bryant was unable to hold her head up without support. Two to three weeks later, she began to have problems swallowing, and eventually needed a feeding tube. At her death, she had dropped to 79 pounds, down 28 pounds from her weight when she got the Botox shots.
The previous May, an Oklahoma jury ordered Allergan to pay $15 million to an Oklahoma City doctor who said she suffered botulism poisoning after using Botox to treat wrinkles. Dr. Sharla Helton complained of severe side effects after getting injections of 50 units of Botox Cosmetic on July 14, 2006.
It was her fifth treatment for wrinkles. She eventually sold her medical practice and stepped down as medical director of Lakeside Women’s Hospital in Oklahoma City because of pain and weakness resulting from Botox side effects.
One juror told The Oklahoman that the jury found negligence because Allergan’s 2006 product labeling did not have adequate information about side effects. The juror said the jury came to that conclusion after comparing a 2006 label with the 2009 label.
If you or a loved one were the victim of a Botox injury, you may have valuable legal rights. To discuss your case with one of our experienced Botox injury lawyers, please fill outulinum toxin. According to the FDA, most of the severe reactions occurred in children treated for limb spasticity associated with cerebral pals our online form or call 1-800-YOURLAWYER (1-800-968-7529) today.
In February 2008, the Food Drug Administration (FDA) announced that Botox, Botox Cosmetic and Myobloc would undergo a safety review following reports of serious side effects, including the deaths of some children. Botox, Botox Cosmetic and Myobloc are injectable drugs that contain boty, an off-label use of the drugs.
Botox, which is made with botulinum toxin type A
Botox, which is made with botulinum toxin type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).
Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Myobloc, which is made from botulinum toxin Type B, is approved for the treatment of adults with cervical dystonia.
In January 2008, the consumer advocacy group Public Citizen petitioned the agency two weeks ago to strengthen warnings on the products’ labels because of serious adverse reactions.
An analysis conducted by Public Citizen of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, the makers Botox, Botox Cosmetic and Myobloc had reported 180 U.S. cases of people developing serious conditions after receiving injections. Those 180 cases included 16 deaths, four of which occurred in children.
According to the FDA the Botox, Botox Cosmetic and Myobloc reactions reported resemble botulism. The reactions have occurred when botulinum toxin spreads beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity.
Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may be due to overdosing
The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis. Some reports. Among the adult cases that were serious, including hospitalization, none required intubation or ventilatory support. No deaths were reported.