By Truman Lewis
ConsumerAffairs.com
Here's the latest wrinkle in the long-running Botox case: Botox manufacturer Allergan has agreed to pay $600 million to settle federal charges that it illegally promoted so-called "off-label" uses of the drug.
The U.S. Food and Drug Administration (FDA) has approved Botox only for use in rare conditions but prosecutors said the company has vigorously promoted it for off-label uses, including relief from headaches, pain, spasticity and juvenile cerebral palsy.
"Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by FDA," U.S. Attorney Sally Yates said. "Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective."
Allergan has agreed to plead guilty to a misdemeanor charge of misbranding Botox in violation of the Food, Drug and Cosmetic Act, federal authorities said. The settlement is not final until approved by a federal judge.
The Irvine, Calif., company was named in both civil and criminal complaints filed in U.S. District Court in Atlanta.
Other cases
In an unrelated case, Botox users and their families are pursuing a class action lawsuit against Allergan, claiming the company failed to adequately warn users of the drug's dangers.
The suit, filed in July 2008, claims the toxin-based drug killed at least three people, including a seven-year-old girl with cerebral palsy who got Botox injections to help control spasticity in her limbs.
The U.S. Food and Drug Administration said in February that Botox was being injected at an alarming rate among children, especially those who are being treated for limb spasticity associated with cerebral palsy.
It noted that neither Botox nor a similar product, Myobloc, was approved for such use in the U.S. and said there have been deaths associated with the usage of the two treatments among children.
In March 2008, Allergan said it had received a subpoena from the U.S. Justice Department seeking documents regarding Botox promotional practices. The company said its understanding was that the inquiry involves questions regarding alleged off-label promotion relating to the use of Botox for the treatment of headache.
The FDA said in February 2008 that it knew of no deaths among adults but the class action, filed in California's Orange County Superior Court, said a 69-year-old Texas nurse and a 71-year-old woman both died after receiving Botox injections.
The nurse had been receiving injections for neck and shoulder pain, while the 71-year-old, who lived in Arizona, was taking Botox at a mall clinic for wrinkles around her mouth. The suit says she had trouble breathing and swallowing after the treatment and died a short time later.
All three of the cases involved uses of Botox that are not approved by the FDA.
The suit also charges that Botox left at least 12 other patients with a range of disabilities, including some who were taking the drug for approved uses, such as smoothing frown lines.
Approved uses
Botox and Myobloc are designed to block nerve impulses to certain muscles, causing them to relax. Both products are approved to treat cervical dystonia, or uncontrolled muscle contractions of the neck and shoulder muscles. Botox is also approved for cosmetic use to treat wrinkles between the eyebrows and to help control excessive underarm sweating.
In some cases, the toxic, active ingredient in Botox and Myobloc -- a derivative of botulism toxin Type A, one of the deadliest poisons known -- can affect respiratory muscles and cause difficulty swallowing, a condition known as dysphagia. Both products warn doctors and consumers of that side effect.
The the FDA said in February that what is new is that it appears the active ingredient in Botox can spread from distant parts of the body -- such as children's leg muscles -- to muscles that affect breathing rather than being just a local event as previously believed.
In January, the consumer group Public Citizen said it found 16 deaths reported with usage of Botox or Myobloc from November 1997 through 2006. The group filed a petition with the FDA seeking the agency's strictest black-box warning discussing difficulty swallowing, pneumonia as a result of food getting into the lungs and, in rare instances, death from pneumonia.
The suit charges that several of the plaintiffs were hospitalized and now suffer from chronic, life-altering conditions, including difficulty swallowing.
"Thousands of people are getting these injections with no warning to speak of," said Ray Chester, one of the lawyers representing plaintiffs in the suit.
Allergan maintains the drug is safe and says millions of people have taken it with no problems.
