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HEART VALVE DAMAGE RISK INCREASED WITH PARKINSON’S DISEASE MEDS

Permax (pergolide) and Dostinex (cabergoline) are ergot derivative dopamine agonists prescribed to treat patients with Parkinson’s disease and hyperprolactinemic disorders. Dostinex was approved by the U.S. Food and Drug Administration (FDA) in 1996 to treat hyperprolactinemic disorders only. Permax was initially approved by the FDA in 1998 and was manufactured by Eli Lilly & Co.

Side effects of these medications include:

  • Nausea
  • Constipation
  • Vomiting
  • Headache
  • Dizziness
  • Fatigue
  • Hot flashes
  • Somnolence

Unfortunately, these Parkinson’s disease medications can cause serious and potentially life threatening conditions in the heart. Permax, deemed too dangerous and unsafe for human use, was recalled completely by the FDA and is now only available to treat endocrine diseases in horses.

PERMAX WITHDRAWN FROM MARKET DUE TO SERIOUS HEART VALVE PROBLEMS

In 2006, the FDA added a black box warning — the FDA’s strongest warning label — to Permax labels regarding an increased risk of heart valve damage. The label stated that some patients required valve replacement and that there were deaths reported with Permax use. A year later, two studies revealed that the risk of heart valve disorders may be higher than first believed.

People taking the drug for longer periods of time at higher doses were found to be at the greatest risk of developing heart valve damage. One of the studies found that 23 percent of those taking Permax and 29 percent of those taking Dostinex had damaged heart valves — only six percent of people taking placebo had heart valve damage. The other study that the FDA reviewed showed that heart valve problems were seven times as likely to occur in people taking Permax and five times as likely to occur in people taking Dostinex compared to control groups.

The findings were published in The New England Journal of Medicine in January 2007. Two months later, the FDA issued a voluntary recall of Permax, and the dangerous drug was removed from the market.

Because Dostinex was not approved for use in Parkinson’s disease patients and a lower dose of Dostinex is used to treat hyperprolactinemic disorders, the drug was not removed from the market. At these lower doses, the increased risk of heart valve problems is not seen.

CONTACT AN EXPERIENCED DANGEROUS DRUG INJURY LAWYER

If you or a loved one have suffered heart valve damage after taking Permax or Dostinex, contact Thomas J. Henry. Our experienced pharmaceutical drug injury attorneys are available 24/7, nights and weekends to evaluate your claim and see if you are entitled to compensation. Heart valve disorders can leave you with a lower quality of life and could cause severe, life-threatening conditions. We have the legal and financial resources necessary to take on the pharmaceutical companies. Don’t wait — contact us today for a free case review.

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