One way to learn how to provide botulinum toxin safely is to take a look at the cases that have been filed involving the medication. Here are two:
A Houston surgeon was convicted in 2007 of conspiracy, mail fraud, and misbranding a drug after she substituted a cheaper, unapproved form of botulinum toxin for the approved form. She learned about the cheaper form when it was promoted at a conference. Her consent document indicated she was using the approved form of Botox®. In addition to her criminal conviction, two patients sued, saying they now suffer from neurologic problems resulting from the unapproved substance.
In July 2008, 15 Botox users and their relatives sued Allergan, Inc., the manufacturer of Botox, claiming the company failed to warn them of the drug's dangers. The most common side effect cited in the suit was loss of ability to swallow. Three plaintiffs sued for wrongful death. All of the deaths occurred in patients who received the drug for indications that weren't approved by the FDA. Other patients, some of whom used the drug for approved indications, contended Botox caused disabilities including blurred vision, numbness, muscle weakness, and difficulty breathing. Three of the plaintiffs were receiving the treatment for cosmetic purposes. One patient died after treatment for smile lines. Several of the patients suffered from chronic conditions.
More filings are likely. In January 2008, the consumer group Public Citizen announced that it found reports linking 16 deaths to use of Botox Myobloc® between 1997 and 2006. The group also found 180 patients who developed life-threatening conditions after being injected.
The issues discussed in this column are not meant to be considered legal advice. For personal advice, readers are urged to contact a qualified health care attorney.
Dermatology Nursing. 2008;20(6):473-474,492. © 2008 Jannetti Publications, Inc.
Cite this: How To Reduce Your Risks When Providing Botulinum Toxin - Medscape - Dec 01, 2008.