Unapproved, “Off-Label” Uses of Botox Cause Patient Deaths and Injuries
Tuesday, July 22, 2008
Botox, the blockbuster wrinkle fighting drug touted as a quick and easy way to look younger, has caused scores of deaths and devastating injuries in patients who took the drug for cosmetic and therapeutic uses that have not been approved by the Food and Drug Administration, according to a recently filed civil lawsuit.
The suit was filed on July 9, 2008 by the law firms of Mark & Associates, P.C., and McGinnis, Lochridge, Kilgore, L.L.P., on behalf of 15 Botox patients from across the United States. It alleges the drug’s maker, Allergan, Inc., of Irvine, California, has failed to adequately warn Botox users and medical professionals of the risks of taking the drug, while promoting unapproved, “off label” uses of Botox for the treatment of cerebral palsy and other conditions.
Botox is made from Botulinum Toxin A, a purified and diluted form of botulism, which in its undiluted state is among the deadliest known diseases. The drug temporarily stops muscle movement, which can reduce the appearance of Crow’s feet, laugh lines, and other wrinkles in the skin around the eyes, nose, mouth and forehead.
Lawsuit Targets “Off Label” Uses of Botox
The lawsuit casts light on a little-known but troubling reality: Doctors are using Botox in ways the FDA has not evaluated or approved, causing patient deaths, respiratory paralysis, and other life-threatening injuries to patients who do not know the dangers of Botox.
Allergan actively promotes using Botox in ways that do not have FDA approval, according to the suit. These “off label” uses can be extremely dangerous, since no formal study of their success or side effects have been done. Many of these alternative uses of Botox are devised by physicians who experiment with the drug in an effort to treat patients who are suffering from a wide range of physical ailments. Very high doses of the drug are often administered in these unapproved Botox treatments.
Allergan regularly holds doctor conferences across the nation where off-label uses of Botox are discussed and the known negative results of the uses are downplayed, the lawsuit states. In doing so, the company irresponsibly exposes patients to unknown side effects that have resulted in devastating consequences.
Botox is FDA-approved for cosmetic uses and for the treatment of other non-cosmetic conditions, including cervical dystoncia, blepharospasm, strabismus, and excessive underarm sweating. The drug is also used for unapproved treatments. One such treatment involves administering large doses of the muscle-numbing drug in an attempt to stop debilitating muscle spasms (limb spasticity) that are common in cerebral palsy patients as young as 6 and 7 years old.
The parents of a 7-year-old Amarillo, Texas girl who died after being given Botox as part of her cerebral palsy treatment are among the plaintiffs suing Allergan. After the girl received Botox, she developed pneumonia, her seizures dramatically worsened, and she died in November 2007.
FDA Warns Consumers About Botox
Botox drew fire from the FDA in February 2008, when the agency issued a public health warning to consumers and health care provides about widespread reports of deaths, breathing problems, and other adverse reactions to the popular drug. Many of the reported deaths and injuries involved unapproved, off-label uses of Botox in young patients suffering from muscle spasms associated with cerebral palsy.
In some of the cases involving patients who died from Botox, large doses of the drug were given to children. Once administered, the drug migrated inside their bodies from the injection point into the muscles around the lungs, ultimately interfering with breathing and swallowing. The FDA warning also concerned Myobloc, a product similar to Botox made by Solstice Neurosciences, Inc. to treat chronic neck pain.
Off-Label Uses Should Be Prohibited
The FDA warning, while arguably long overdue, was a positive step in the right direction. However, the agency has failed to adequately regulate Allergan’s continuing promotion of off-label uses of Botox. Allowing the drug maker to tout Botox as a treatment for cerebral palsy, muscle spasms, and other unapproved uses needlessly puts untold numbers of patients at risk of death and life-threatening adverse side effects.
Attorneys representing the plaintiffs in the lawsuit against Allergan insist that the company stop pushing unapproved, off-label uses of Botox. Patients who are subjected to unproven uses of Botox are unknowingly put in jeopardy of deadly, adverse reactions, which could be prevented by FDA review and approvals. By pushing Botox as an alternative, unapproved therapy, Allergan is allowing unnecessary deaths and injuries to occur.
Posted under: Dangerous Drugs • Botox