Botox Lawsuit - Botox Lawyer - Botox Side Effects - Botox Attorney - Botox FDA Warning |
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Botox Side Effects Lawsuit:
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Botox Side Effects Lawsuit:
Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
The FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by the FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.
The FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy, including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. The FDA is also requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.
What is Botox:
Botulinum toxin is a neurotoxin protein produced by the bacterium Clostridium botulinum. It is sold commercially under the brand name Botox. Botox has been approved by the FDA to be used in very small doses both to treat painful muscle spasms and as a cosmetic treatment. It is used in the treatment of migraine headaches, blepharospasm, cervical dystonia, and many other medical issues. Since 2006, Botox has been the most commonly used cosmetic treatment in the United States. Botox has also been used in treatments not approved by the FDA such as treatment of limb spasticity of cerebral palsy or for use in any condition in children less than 12 years of age.
Botox Side Effects:
The FDA’s public notification came after severe, adverse reactions were found in both FDA-approved and non FDA-approved usages. The most severe reactions were found in children after the treatment of limb spasticity of cerebral palsy. These adverse reactions are occurring after the toxin spreads in areas away from the injection site. The FDA is not advising health care professionals to discontinue prescribing these products as they have not fully completed their investigation.
Symptoms of an adverse reaction to Botox will be closely related to those of botulism and may include:
- Difficulty breathing
- Difficulty swallowing
- Weakness and numbness of the lower extremities
- Respiratory Distress
- Death
If you or a loved one have been injured or suffered a loss due to Botox side effects you may be entitled to compensation. Contact the Botox Lawyers of Ennis & Ennis, P.A. today for a free Botox case evaluation by filling out the form on this page or calling toll-free: 1-800-856-6405.
