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FDA Requires  Botox®  Maker to Notify of Potential Adverse Effects

FDA Requires Botox® Maker to Notify of Potential Adverse Effects


Jon L. Gelman  is investigating cases on behalf of individuals with Cerebral Palsy who suffered serious injury or sudden death related to respiratory distress during or after using Botox®.

Botox®, Botox® Cosmetic and Myobloc® are botulinum toxins types A and B that the FDA approved for the treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), severe primary axillary hyperhydrosis (excess sweating) and facial lines.

If you or a loved one may have experienced adverse side effects while being treated with Botox®, contact attorney Jon Gelman by email or call +1 973-696-7900.

Drug History and Serious Adverse Reactions
Botox® Cosmetic, initially approved by the FDA on December 9, 1991, is approved for the temporary improvement of moderate to severe facial frown lines. Myobloc®, initially FDA-approved on December 8, 2000, is specifically indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain. Following an initial public petition by Public Citizen Action Group of  January 23, 2008, a formal investigation was initiated. On February 8, 2008 the FDA issued an early communication about ongoing safety issues
regarding Botox and Botox Cosmetic.

While there is some scientific literature describing the use of botulinum toxins for treatment of limb spasticity in children, the safety, efficacy and dosage amounts have not been established for treatment of limb spasticity in those having cerebral palsy or any condition in children under the age of 12 in the United States.

On April 30, 2009 the FDA announced a safety evaluation of the product because of potential adverse reactions that include respiratory distress and death following the use of botulinum toxins types A and B for both approved and unapproved usage. According to the FDA's Early Communication about an Ongoing Safety Review, reports indicated that the botulinum toxin spread beyond the injection site. The most serious adverse reactions led to hospitalization and death and the majority were children treated for cerebral palsy-associated limb spasticity. Botulinum toxins are not approved for treatment of limb spasticity in children or adults in the U.S. 

The FDA has issued an alert on August 3, 2009 concerning OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc) . The FDA notified healthcare professionals of changes to the established drug names for Botox/Botox Cosmetic, Dysport and Myobloc to reinforce individual potencies and prevent medication errors, and provided recommendations for healthcare professionals to consider, plus information for patients, family members, and caregivers.

The FDA reviewed safety data from clinical studies submitted by the manufacturers of Botox®, Botox® Cosmetic and Myobloc®. These manufacturers include Allergen and Elan Pharmaceuticals, both located in the United States.

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