May 13, 2009

Last year, Botox^®, a medication containing Botulinum Toxin A, was routinely injected into over 2.5 million Americans and generated $1.3 billion in sales. All this despite reports that Botox could cause symptoms similar to botulism, loss of bladder control, blurred vision, trouble breathing, swallowing and talking (not because of the size of those lips). Certified Legal Nurse Consultants working for plaintiff and defense firms should be aware that on April 30, 2009, the FDA issued a statement that all botulinum toxin products (including Botox and Botox Cosmetic) carry a black box label warning as well as a risk evaluation and mitigation strategy (REMS).

A black box is the strongest safety warning that a medication can carry and is so named for the black border that usually surrounds the text of the warning. These bold-faced labels carry risk information and are most often found on medications that have a probability of serious or life-threatening side effects. When combined with the REMS, their purpose is to alert healthcare professionals prescribing or dispensing the medication, as well as the patients receiving it, to health issues and dangers associated with its use. Botox, Botox Cosmetic, Myobloc^® and Dysport^® will all carry the FDA warning. Consumers experiencing serious adverse events (med-speak for side effects) from use of any of those products can report them to the FDA online as part of the FDA’s MedWatch Adverse Event Reporting program.

While the placement of a warning on the box does not free the manufacturer or healthcare professional from liability for damages caused by the product, it may give rise to an assumption-of-the-risk defense in certain cases. Botox and its kin are not used solely for cosmetic purposes. They do have some legitimate medical applications (treatment of cerebral palsy and cervical dystonia). I’ve always felt that we can’t insert or inject a foreign substance into our bodies without expecting some sort of side effect. So the next time a friend or relative tells you they’re considering the cosmetic use of Botulinum Toxin A to reduce wrinkles or to stop sweating, the savvy legal nurse consultant should tell them to consider that they’ve been warned.

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