How To Reduce Your Risks When Providing Botulinum Toxin

Carolyn Buppert

Disclosures

Dermatology Nursing. 2008;20(6):473-474,492. 

In This Article

First Case

The first case involving Botox went to trial in 2004 and ended in a defense verdict. In that case, a California woman sued the maker of Botox and her dermatologist, claiming she suffered life-altering intractable headaches, fibromyalgia, extreme neck weakness, difficulty breathing, difficulty swallowing, and extreme fatigue, following her March 4, 2002 treatment with Botox for cosmetic purposes and for migraines. Botox was approved by the FDA for cosmetic use since April 15, 2002, so her treatments were off-label. She claimed that she was bedridden for 4 months, that she lost a reality television show opportunity, and that she continued to suffer from the effects. The claims against her dermatologist included medical malpractice, breach of fiduciary duty, intentional misconduct, and violations of section 17200 of the California Business & Professions Code (deceptive advertising). Her case highlighted the off-label usage and dosing higher than the approved amount. A jury decided that the woman's illnesses were unrelated to Botox.

Allergan lists the following possible reactions on its Botox Web site: anaphylaxis, urticaria, soft-tissue edema, and dyspnea. One case of anaphylaxis was fatal. In that case, lidocaine was used as a diluent. The most common adverse events following injection include blepharoptosis and nausea. Localized pain, infection, inflammation, tenderness, swelling, erythema and/or bleeding/bruising may be associated with the injection. Patients with neuromuscular disorders such as amyotrophic lateral sclerosis, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious adverse events.

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