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Permax Recall

The U.S. Food and Drug Administration announced a Permax recall on March 29, 2007 after several studies linked the drug to an increased risk of heart valve damage. The recall was long overdue — the drug was first associated with heart risks in 2002. By the time of the recall, hundreds of thousands of Americans had used Permax to treat the symptoms of Restless Leg Syndrome (RLS) and Parkinson’s disease.

Long Road to Permax Recall

In 1989, the FDA approved Permax for use in the United States. It took nearly two decades for the FDA to recall the drug, even though one expert wondered how the dangers of the drug could have been missed given the extremely high incidence of heart valve damage in patients taking Permax.

Prior to the recall, the drug was the subject of various safety studies and regulatory actions including:

  • December 2002 – Mayo Clinic Proceedings. Researchers present findings that show an association between Permax and heart valve damage.
  • October 2003 – The FDA asks the maker of Permax, Eli Lilly, to revise the drug’s labeling to include cardiac valvulopathy under the warnings.
  • March 2004 – University of Texas Southwest Medical Center study finds two- to threefold increased risk of valvular heart disease in patients taking Permax (pergolide).
  • April 2004 – An abstract published in the Lancet encourages doctors to consider alternative treatments to Permax because of the risk of valvular heart disease.
  • October 2006 – Black box warning added to Permax’s label to highlight risk of valvular heart disease.
  • January 2007 – Two studies published in the New England Journal of Medicine demonstrate an increased risk of valvular heart disease in patients taking Permax and Dostinex, a similar drug.
  • March 2007 – FDA issues Public Health Advisory announcing Permax recall. According to the FDA, the benefits of Permax do not outweigh the risks.

Months after the U.S. recall of Permax, Health Canada also announced a recall of the drug.

Contact a Permax Lawyer

It’s clear that the dangers of Permax were known long before the drug was pulled from the market. Sadly, many thousands of people have taken the drug, and many may have suffered serious health effects. If you suffered heart damage because of Permax, you should consult with an experienced attorney to learn more about your legal rights. To arrange a complimentary, private consultation, contact us today.

Contact a Permax Recall Lawyer

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