Manufacturer: Valiant Pharmaceuticals, Par, Teva
Date approved: 1988
Status: Voluntary market withdrawal after FDA alert
Approved uses: Treatment of symptoms of Parkinson’s disease, including tremors and slow movements
Off-Label uses: Treatment of restless leg syndrome
Pergolide can cause side effects including disrupted digestion, nervous symptom complaints like hallucinations or insomnia
and rhinitis. In 2007 Pergolide was linked to severe heart valve damage in some patients and withdrawn from the market.
Pergolide (marketed as Permax) is a dopamine agonist drug (DA) used in the treatment of the tremor and slowness associated with Parkinson’s disease. The drug was approved for use in 1988 and is manufactured by Valeant Pharmaceuticals. In 2007, the federal Food and Drug Administration (FDA) published a public health advisory warning patients against Pergolide after a study by the New England Journal of Medicine implicated that a previously unknown Pergolide side effect was heart valve damage. Patients who are taking Pergolide are warned to discontinue use with a doctor’s assistance.
Parkinson’s Drug Pergolide (Permax) Taken Off Shelves
A federal Food and Drug Administration (FDA) report of recent studies has demonstrated the dangers of Pergolide (Permax) to patients with Parkinson’s disease. Now manufacturers Valeant Pharmaceuticals, Teva and Par have pulled the drug from shelves in just one of a recent spate of voluntary recalls. The drug, a so-called dopamine agonist (DA) that helps to calm tremors and increase balance in Parkinson’s patients, has been linked to dangerous side effects, including an increased risk of heart valve damage in some patients.
More About Pergolide
Pergolide (Permax) is a dopamine agonist medication indicated in the treatment of patients with Parkinson’s disease. Parkinson’s, which is a central nerve system disorder, takes place when cells located in the brain’s substantia nigra die, causing the nervous system to fire repeatedly and without control. The symptoms of Parkinson’s may come on gradually and increase over time. Parkinson’s symptoms include trembling or tremors, slowness or clumsiness, stiff and rigid limbs and trunk, and other neurological symptoms. Pergolide works by restricting the nerve cells which fire out of control in Parkinson’s patients, calming tremors and restoring movement.
Pergolide was approved in 1988 and was originally marketed by drug giant Eli Lilly before being taken over by Valeant and its generic distributors, Par and Teva. The drug, which is called Permax in its non-generic form, ran into problems in 2003, when Eli Lilly distributed a “Dear Doctor” letter citing the drug’s links to cardiac valvulopathy (damage to the heart valves) that ceased after the drug was discontinued. However, the letter noted that of over 500,000 patients, less than 0.005 percent presented with heart valve damage, and Pergolide continued to be sold throughout the United States.
However, the 2003 letter was only the beginning of Pergolide’s troubles. Studies revealed in 2006 prompted the FDA to order a “black box” warning label. More recently, two January 2007 studies appearing in The New England Journal of Medicine indicated that roughtly 23 percent of patients taking Pergolide develop heart valve problems; in fact, patients who take Permax or Pergolide are five times as likely to develop heart valve problems as patients who do not take the drug. This is saddening news to the nearly 25,000 patients who currently take Pergolide in the United States alone; these patients will have to replace a valuable drug that helps manage Parkinson’s devastating symptoms. However, heart valve damage can be just as devastating, since the condition is not treatable through non-invasive means and requires costly and dangerous open heart valve surgery.
If You’ve Taken Pergolide or Permax
If you are a Parkinson’s patient who currently takes Pergolide or Permax or has taken it in the past, contact your physician before discontinuing the drug. Your doctor will be able to help you wean off Pergolide and replace it with an appropriate Parkinson’s treatment and can also assess your heart valve condition. If you have sustained heart valve damage due to your use of Pergolide, get appropriate medical care as soon as possible; then contact an experienced unsafe drugs attorney who can help evaluate your possible Pergolide lawsuit. You may be able to obtain compensation for your injuries and be paid for past and future medical care. Looking for a Pergolide lawyer to help with your Permax claim? Contact LegalView.com today for a confidential referral.
Pergolide Recall: What’s Next for Parkinson’s Patients?
With the recent recall of Pergolide from store shelves after the drug (also marketed as Permax) was linked to heart valve damage in two recent studies. But now that the Pergolide recall is in effect, what comes next for patients who suffer from Parkinson’s disease?
Why Recall Pergolide?
Pergolide (Permax) was relied upon by nearly 25,000 Parkinson’s patients to quell tremors and restore normal balance and movement associated with the nerve disorder. However, two recent studies linked Pergolide to heart valve damage, a serious condition that is not treatable through medication and can only be repaired through costly and dangerous open-heart surgical procedures. The studies revealed that up to 23 percent of Parkinson’s patients who take Pergolide are at risk for heart valve damage and that the drug causes five times the risk of similar dopamine agonists. The FDA has reported at least 14 cases in which Pergolide-related heart valve replacement was necessary; however, given the fact that only an estimated one to ten percent of all medication complications are reported yearly, the actual number may be far higher than reported.
Are There Other Options for Pergolide Users?
Unfortunately, the nature of Parkinson’s medication is such that some users only do well on a particular drug. This will leave thousands of Parkinson’s patients who depended on Pergolide and Permax in the lurch. However, the recall is slated to occur in phases and some doctors may be able to get clearance to prescribe Pergolide to patients who only respond well to that particular dopamine agonist — but patients who continue Pergolide will be taking on a significant risk. Heart valve replacement surgery is a significant procedure, both on financial and functional fronts, and mechanical heart valve replacements can present additional problems, such as the need for lifelong blood-thinning medication or replacement valves every ten years.
What About Dostinex?
If you’re thinking of asking for an off-label prescription of Dostinex, the Pfizer-manufactured drug that is used to treat Parkinson’s in other countries, think again. Not only has Dostinex not been approved for the treatment of Parkinson’s in the United States, but it is also linked to heart valve damage for some Parkinson’s patients. The Internet is a great place to find out about unsafe drugs, but it can’t provide alternatives — the only good alternative is an experienced Parkinson’s specialist who can evalute symptoms and recommend an alternative drug to help manage symptoms.
Decisions and Alternatives to Pergolide
If you are trying to decide whether to continue Pergolide usage, contact an experienced Parkinson’s specialist immediately and gain a global perspective of the risks and benefits. Your doctor can help you wean yourself off of Pergolide and decide on an alternative to help manage your Parkinson’s symptoms. If you have sustained heart valve damage, make sure to contact an experienced Pergolide attorney in addition to your doctor. A good Pergolide lawyer can help evaluate your potential lawsuit and assist you in filing a claim for damages, including medical expenses, lost wages and future medical care.