May 5, 2009: Botulinum Toxin Products To Carry Black Box Warning

May 5th, 2009

Serious Adverse Events Are Linked To Botulinum Toxin Products:

The FDA will require labeling for the botulinum toxin products BOTOX®, Myobloc®, Dysport® to include a “Black Box Warning,” alerting doctors and patients of the serious and life-threatening side effects that these products can trigger.  A Black Box Warning is the strongest warning that the FDA can require a prescription drug to include in its labeling. 

Botulinum Toxin Products Labeling Change:

BOTOX®, Myobloc®, and Dysport® all contain the same toxin that causes botulism.  The FDA has mandated the Black Box Warning following reports that the effects of the botulinum toxin may spread from the injection site to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

In its News Release, the FDA stated that these side effects have been reported most frequently in children with cerebral palsy and being treated with the products for muscle spasticity, an unapproved use of the drugs. Side effects have also been reported in adults treated both for approved and unapproved uses.

The updated labeling changes will also include safety information alerting doctors that BOTOX®, Myobloc®, and Dysport® are not interchangeable.  The lack of interchangeability presents the potential for serious safety risks such as overdosing of patients.

What You Can Do To Protect Your Legal Rights:

Since 1984, the Law Firm of Eric H. Weinberg has represented hundreds of individuals injured by dangerous and defective drug products.  The firm has played a leading role in the litigation of high-profile drug lawsuits including Vioxx, Baycol, and blood products.  We are ready to help you.  If you believe that you or a family member was injured as a result of BOTOX®, Myobloc®, Dysport® therapy please submit a Free Case Evaluation Form, or call us toll free at 1-877-934-6274.

To learn more about the Law Practice of Eric H. Weinberg, please see Drug Lawsuit Lawyer and Food Poisoning Lawyer.

Entry Filed under: Recent Outbreaks and Food Recalls

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