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South Carolina Wrongful Death: Required Black Box Warning Label

South Carolina Wrongful Death: Required Black Box Warning Label

Charleston medical malpractice lawyers want to warn doctors and consumers that Botox and popular Botox manufacturer Allergan are now required by the Food and Drug Administration to place a black box warning label on their product due to the serious side effects and deaths that have occurred when using the product for non-therapeutic reasons. Botox Cosmetic is approved for temporary cosmetic procedures and Myobloc, a similar drug, is approved for combating severe neck and muscle spasms in adult patients. Neither drug has been approved for children under the age of twelve.

Some doctors administer Botox and Myobloc for off-label purposes, and the side effects have resulted in severe personal injury and death. The Food and Drug Administration evaluated reaction reports of patients who had received Botox and Myobloc procedures. After reviewing these reports in August, the FDA decided and mandated that both drugs carry a black box warning label. The warning explicitly states the severity of the side effects associated with the use of the drug. After receiving a Botox injection a patient can experience side effect symptoms in hours up to seven days. These sometimes severe side effects are similar to the flu and can alter breathing to the point where hospitalization is required. Due to the onset of severe symptoms and hospitalization many of these cases are not identified as Botox-related until much later on.

In 2003, Irene Medavoy sued Allergan for “debilitating ailments” after receiving Botox treatments. She claimed to have received treatments for migraine headaches, and her Botox treatments did not help her migraines and in return made her fatigue, gave her respiratory problems, and fevers. The jury sided with Allergan and found the company not guilty. This was prior to all of the new information and facts on patients’ side effects. When cases are brought before a jury today involving Botox or Allergan, the facts are not in the drug or manufacturer’s favor.

The onset of cases today can be attributed to the fact that once the drug is administered it takes years for patients to experience side effects. Recently there has been more research done involving the drug, its popularity has increased substantially, and the FDA has conducted more tests on it. Because of these new findings and tests there is now plenty of evidence to present to a jury to build a case against Allergan and Botox, which is why there has been such an increase in Botox related injury cases in the past few years.

Source: South Carolina Lawyers Weekly-“Litigation puts a wrinkle in Botox.” December 21, 2009.

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