Permax Recall

Modified on 2009/10/14 21:42 by admin
Updated 30 March, 2007

FDA Announces Gradual Recall of Permax

In a public health advisory issued to allĀ  Permax users, the US Food and Drug Administration recently announced the voluntary, but non-immediate recall of this Parkinson's Disease drug by its manufacturer due to potential adverse side effects related to damaged heart valves.

In their advisory, the FDA further emphasized the need, for Parkinson's patients using this drug, to consult with their primary healthcare provider regarding an alternative treatment before discontinuing the use of Permax.

Abrupt discontinuation of Permax, they stated , may lead to other dangerous side effects.

Permax, also known as Pergolide Mesylate, is indicated for the treatment of Parkinson's disease. Usually taken together with carbidopa and levodopa, Permax fights the diminishing effects of Parkinson's by directly stimulating postsynaptic dopamine receptors in the nigrostriatal system.

Permax comes as a tablet to take by mouth. Initially it usually is taken once a day with food or milk, and then the dose may be gradually increased to three times a day. Permax was approved by the U.S. Food and Drug Administration in 1988 and is made by Eli Lilly & Co.

Other adverse side effects of Permax use include, but may not be limited to, chest pain, irregular heartbeat, respiratory problems, hallucinations, severe confusion, nausea and vomiting.

In December 2002, a Mayo Clinic report indicated that Permax may be associated with heart-valve damage. (see update above) Similar to complications experienced by people who took the fen-phen diet drug, the damage was seen in three patients between the ages of 61 and 74. Two of the patients were forced to undergo heart-valve replacement surgery. Eli Lilly plans to change the medication's label to highlight the potential for valve damage.

In February 2003, Lilly and the FDA revised the WARNINGS section of the prescribing information to inform healthcare professionals of reports of cardiac valvulopathy (valvular disease of the heart) involving one or more valves in patients receiving Permax therapy.

In December 2003, FDA and Lilly modified the WARNINGS and PRECAUTIONS sections to inform healthcare professionals of the possibility of patients falling asleep while performing daily activities, including operation of motor vehicles, while receiving treatment with Permax. Many patients who have fallen asleep have perceived no warning of somnolence. Healthcare professionals should be alerted to the potentially serious risks associated with these events and should carefully evaluate their patients for the presence of somnolence.

See your doctor if you have experienced serious side effects associated with Permax. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

Attorneys associated with will evaluate your case free of charge. In addition, you will not pay any fees or costs unless your attorney recovers money for you. Please click on the free Ask An Attorney link to take advantage of this valuable service.

See Also

  1. Parkinson's Disease Drugs: Overview
  2. Arrhythmia: Overview
  3. Hallucinations: Overview
  4. Heart Valve Disorders: Overview
  5. Lung & Airway Disorders
  6. Nausea: Overview
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