FDA Requires Black Box Warning on Botox, Botox Cosmetic and Myobloc

May 1, 2009 – Botox FDA Warning has been issued following reports linking Botox, Botox Cosmetic and Myobloc to birth defects, respiratory failure and death.  The U.S. Food and Drug Administration (“FDA”) has mandated that manufacturers of licensed botulinum toxin products add a Black Box Warning regarding the risk that the effects of the toxin can spread beyond the injection site.  In addition to the Botox FDA Warning, the FDA is requiring that Botox manufacturers develop and implement a Risk Evaluation and Mitigation Strategy (“REMS”).  The Botox FDA Warning requires drug makers to distribute a Medication Guide alerting patients of the potential risks, and to submit safety records.

FDA Safety Review

The Botox FDA Warning is a Black Box warning, which is the FDA’s strongest type, and was issued following an investigation it initiated in February 2008. In January 2008, the consumer advocacy group, Public Citizen, petitioned the FDA to add a Botox FDA Warning on the products’ labels because of serious adverse reactions, and cited 180 cases of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths.

Botox FDA Warning Result of Off-Label Use

The Botox FDA Warning stems from the use of botulinum toxin, the active ingredient in Botox, which blocks nerve impulses to muscles. The FDA has only approved its use for a limited number of therapeutic conditions. It has not been approved for the treatment of limb spasticity, nor has it been approved to treat any condition in children less than 12 years of age. However, the investigation, which resulted in the issuance of the Botox FDA Warning, revealed that the botulinum toxin was administered to children with cerebral palsy for associated limb spasticity.

Botox Also Linked to Birth Defects

In December 2008, Australian authorities reported that Dysport, an anti-aging wrinkle treatment, was administered during pregnancy to a child who was born deaf and blind. Although Dysport is not available in the United States, it contains botulinum toxin Type A, the same active ingredient in Botox and Botox Cosmetic.

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About Bernstein Liebhard

BL is a nationally recognized law firm located in New York City that exclusively represents injured plaintiffs in a variety of individual and class actions.  We have been ranked among the top plaintiffs law firms in the country by the National Law Journal for the past nine years–an honor achieved by only one other law firm in the United States.  Our experienced Botox trial attorneys are standing by ready to review your case.  We represent our injured clients on a contingency fee basis, meaning that we advance all costs and do not collect any attorneys fees unless we are successful.