Permax and other Pergolide products have been recalled due to serious cardiovascular risks.
On March 29, 2007, the makers of Permax (pergolide) in cooperation with the Food and Drug Administration (FDA) ordered the withdrawal of all pergolide products from the market. The Permax / pergolide recall was ordered due to serious Permax side effect risks, including heart valve damage. The risk of Permax heart valve damage has been known since 2002.
If you or a loved one is taking Permax or other pergolide products, it is important to speak with your health care professional before making any changes to your treatment regiment. Stopping Permax suddenly can also lead to serious adverse effects.
If you or a loved one has been harmed by Permax or other pergolide products, you may be entitled to compensation for your losses. To learn more about your legal rights, please contact a qualified Permax lawyer or Permax attorney at Oshman & Mirisola today for a free confidential consultation.
The FDA has ordered the recall of pergolide products currently produced by Valeant Pharmaceuticals, Par, and Teva.
Permax is an oral prescription medication originally manufactured by Eli Lilly Pharmaceuticals. Permax / pergolide is an ergot alkaloid drug belonging to a class of drugs called dopamine agonists. This drug is used to treat the symptoms of Parkinson’s disease affecting movement, such as tremors and slow movement.
Parkinson’s disease is a progressive disease affecting the central nervous system, which causes tremor, rigidity, slow movements, and postural instability (i.e. impaired balance and coordination). Secondary symptoms of Parkinsons disease can include speech problems, loss of facial muscle control, trouble swallowing, confusion, skin problems, constipation, memory problems, loss of energy, and more.
Permax and related pergolide products were originally approved in 1989 as an adjunct therapy to be used concurrently with levodopa and carbidopa treatments. In 2006, approximately 12,000 Americans were taking Permax or pergolide products.
Permax and pergolide have been pulled from the market due to the risk of heart valve damage caused by Permax side effects. The medical name for this condition is cardiac valvulopathy, which means abnormality of the cardiac / heart valves. This condition can effect any of the heart valves including the aortic, mitral, and tricuspid valves.
Two recent studies published in the New England Journal of Medicine, have confirmed that Permax can increase the risk of heart valve regurgitation. Valve regurgitation causes the blood in valves to leak backwards into the valve instead of flowing normally. Symptoms of this serious Permax side effect include heart palpitations (awareness of more forceful or irregular heartbeat), breathing troubles, leg swelling, and fatigue.
Valve regurgitation is a potentially life threatening condition that can lead to myriad health problems such as stroke, heart failure, inflammation, and fibrosis.
Research has shown that stopping the use of Permax and pergolide can improve the symptoms or other manifestations of heart valve damage.
Permax warnings state that use of pergolide products have been known to cause the following conditions:
- Pleuritis, which is inflammation of the lining of the lungs
- Pleural effusion, which is the accumulation of fluid between the layers of membranous tissue in the lungs and chest cavity.
- Pleural fibrosis, which is characterized by a thickening of the lung’s lining
- Pericarditis, or inflammation of the pericardium, which is the membrane surrounding the heart
- Pericardial effusion, which is accumulation of fluid in the pericardium
- Retroperitoneal fibrosis, is a disorder in which the tubes that carry urine from the kidneys to the bladder are blocked.
The recent Permax recall is the not the first instance where Permax side effect risks have prompted action.
In 2002, the makers of pergolide products first became aware of the serious risks of Permax side effects, such as heart valve damage.
In 2003, Eli Lilly sent a “Dear Healthcare Practitioner” letter to doctors across the nation warning them about the rare but serious risk of Permax side effects, described above. In light of this evidence about pergolide side effects, a stronger warning was added to all Permax labeling.
In 2006, the FDA further strengthened the Permax warning to a “black box warning,” the strongest warning label the FDA can require short of a drug recall. This action was a response to additional information about heart valve damage risks.
Certain patients are at a greater risk of serious Permax side effects. Patients with a history of cardiac valve, pleural, or pericardial disorders may be at an increased risk of pergolide side effects. People who have had an adverse reaction to other ergot alkaline drugs—such as bromocriptine (Parlodel), cabergoline (Dostinex), dihydroergotamine (D.H.E., Migranal), ergonovine (Ergotrate), and ergotamine (e.g. Cafergot, Ercaf)—also appear to be at a greater risk.
The risks of adverse Permax events can also increase with concurrent use of other medications. Permax drug interactions may be a greater risk if patients are taking any of the following drugs while using permax or pergolide drugs:
- Anti-anxiety medications
- Drugs for mental illness
- Anti-nausea medicines
- Seizure medications
- Salicylate Pain Relievers
- Sleeping pills
In addition to serious cardiovascular risks, symptoms of Permax side effects also include:
- Trouble moving
- Shortness of breath
- Large unexplained weight gain within a short period of time
- Swelling of the face, ankles, legs, hands, feet, lips, eyes, etc
- Chest pain
- Hallucinations and/or delusions
- Unexplained death
Do not stop or change your medication without first speaking with your doctor. Stopping Permax or pergolide products abruptly can cause serious complications. If you suddenly stop taking Permax, you may experience, muscle stiffness, excessive sweating, increased heart rate, incontinence, fever, confusion, loss of consciousness, and/or hallucinations.
In most cases, you doctor will want to slowly decrease your dose of Permax. Luckily, there are alternative treatments to Permax that are effective for treating the symptoms of Parkinson’s disease. You should speak with your doctor about what medication is best for you.
If you or a loved one has suffered serious harm caused by Permax or pergolide products, you may be entitled to compensation of your medical expenses and more. Please contact our qualified and experienced Permax attorneys and Permax lawyers today to learn more about your rights and options to file a Permax lawsuit.
Oshman & Mirisola can help you make informed decisions about your legal rights, so please call the Permax attorneys at Oshman & Mirisola at Toll Free: 1(800)-400-8182 for your free legal consultation.