Permax Lawyer & Attorney : Fields Law Firm : Minnesota, Iowa, Wisconsin, Arizona, South Dakota, North Dakota

Following two recent studies, the Federal Drug Administration (FDA) announced a Permax recall on March 29, 2007. The Permax recall includes both the name brand Permax (peroglide) and the generic versions of peroglide. Current studies have revealed Permax heart valve disease in around one-fourth of Parkinson's patients who have taken Permax over an extended period of time.

Permax Valvulopathy (valve injuries) first came to the attention of the Federal Drug Administration (FDA) in 2002. Permax was approved by the FDA in 1988. Prior to the Permax recall, the FDA added a black box warning regarding the risk of serious heart valve damage.

Permax side effects including heart valve damage were revealed in the studies published in the New England Journal of Medicine (NEJM). High rates of valve leakage were found in up to 20% of patients prescribed Permax. Dr. Robert Temple, the associate director for medical policy at the Center for Drug Evaluation and Research, stated that Permax (Peroglide) was linked with a fivefold increase in regurgitation of the mitral, atrial, or tricuspid valves compared with the general population. The side effects revealed in these studies were further evidence of the ongoing problems leading to the Permax recall.

Permax, which is also known as Peroglide, is used in the treatment of Parkinson's patients and also for a condition called Restless Legs Syndrome (RLS). Parkinson's disease is caused by the degeneration of neurons in an area of the brain involved with movement control that results in a progressive neurological disorder. Restless legs syndrome is also a neurological condition, however it is often misdiagnosed even though it affects around 2.7% of people in the United States. Permax heart valve damage has been reported in both Parkinson's and Restless Legs Syndrome patients around the United States. The Permax recall is expected to affect the future treatment of both Parkinson's and RLS patients.

Permax was released in 1989 after being developed by Eli Lilly. Over 500,000 people have taken Permax since 1989 to treat Parkinson's and RLS. Two European studies were conducted in Britain and Italy. In the Italian study, of the 155 people who had taken Permax, 23.4% of them developed Permax heart problems. The British study involved 11,417 people who were taking the drug. Patients in the British study were 37 times more probable to develop Permax heart damage problems. Serious Permax heart valve disease has also been reported by the Mayo Clinic in patients who took the drug and were later diagnosed with heart problems.

The FDA has announced that due to the Permax recall patients with Parkinson's should:

·        Contact their healthcare professional to discuss alternate treatment options.

·        NOT stop taking Peroglide (Permax) without consulting their healthcare professional, since stopping Permax can be dangerous and several other effective treatments are available.

The FDA has stated that the effect of the Permax recall will not be immediate. There will be a delay which will allow doctors and patients to arrange for appropriate replacement treatment options. Following the Permax recall, the companies that manufacture and distribute peroglide (Permax) are cooperating with the FDA in the removal of the drug from the marketplace.

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Permax (peroglide) appears to cause heart valve damage in the same way as the weight loss drug combination Fen-Phen. Evidence of Permax heart valve damage problems was recently published in two European studies. In addition, the Mayo Clinic has reported three Permax patients with heart valve problems. Two of the patients diagnosed with heart valve disease required valve replacement surgery.

Fenfluramine and dexfenfluramine, part of the now notorious Fen-Phen drug combination, was prescribed to millions of people in the 1990's. Fen-Phen was voluntarily recalled from the market in 1997 due to similar problems of heart valve disease. In 1999 the manufacturer of Fen-Phen, American Home Products Corporation, agreed to pay $3.75 billion in compensation to patients who used the diet drug prior to its removal from the marketplace after being linked to heart disease.

Fen-Phen was shown to selectively bind to specific receptors in human heart valve cells known at 5-HT2B. A similar mechanism was seen in Permax. The drug is supposed to bind with dopamine receptors in the brain, however an ingredient in the drug causes it to bind with receptors in the valves of the heart.

Similar to Fen-Phen, Permax causes the heart valves to develop fibrous deposits that produce leakage of blood back into the heart. That causes the heart to overwork, which can lead to heart failure and death. The problem can be detected by ultrasound and can be fixed only by heart valve replacement surgery.

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On March 29, 2007, the Federal Drug Administration (FDA) announced a Permax recall. The companies that manufacture and distribute the drug Permax (peroglide) agreed to a voluntary withdrawal of the drug from the market due to new evidence of an increased risk of heart valve damage.

This Permax recall follows two recent studies that revealed heart valve damage in up to 20% of patients taking Permax. The studies, which were published in the New England Journal of Medicine showed that Parkinson's patients who had taken Permax had a much greater incidence of heart valve damage when compared to patients who had not been treated with the drug.

Permax heart valve damage (valvulopathy) was recognized by the FDA in 2002. In 2006, a warning regarding the risk of heart valve damage was added to the label of Permax. The FDA Public Health Advisory for Permax includes the following recommendations for patients and physicians:

Patients with Parkinson’s disease who are taking pergolide should:

• Contact their healthcare professional to discuss alternate treatment options. 
• NOT stoptakingPergolide without consulting their healthcare professional, since stopping pergolide too quickly can be dangerous and several other effective treatments are available.

Healthcare professionals who prescribe pergolide should consider the following:

• Assess the patient’s need for dopamine agonist (DA) therapy.  If continued treatment with a DA is necessary, another DA should be substituted for pergolide.  There are other dopamine agonists approved for the treatment of Parkinson’s disease that are not associated with heart valve damage.  Published transition regimens describe the conversion from one DA to another.
• If treatment with a DA is to be discontinued, pergolide should not be stopped abruptly, because rapid discontinuation of all dopamine agonist therapies can be dangerous.  Instead, gradually decrease the dose of pergolide.
• Patients who will be taken off pergolide should be told that other effective options for treatment exist, including three other DAs that are not associated with damage to heart valves.

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Permax was developed by Eli Lilly and has been on the market since 1989. It is manufactured and marketed in the United States by Valeant Pharmaceuticals International which acquired the previous licensee Amarin Pharmaceuticals, Inc. in 2004.  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. More than 500,000 people have taken Permax since it was approved by the FDA.

Permax is used to treat Parkinson's disease and Restless Legs Syndrome (RLS). Parkinson's disease is associated with low levels of a chemical called dopamine in the brain. Pergolide has some of the same effects as dopamine in the body. Pergolide is used to manage the symptoms of Parkinson's which include tremors and slowness of movement. Permax is often used in conjunction with levodopa and carbidopa in the treatment of Parkinson's disease.

Restless Legs Syndrome is associated with an uncontrollable urge to move coupled with unpleasant sensations in the legs. Dopamine agonists such as Permax are also used to treat Restless Legs Syndrome and have been found to reduce RLS symptoms.

Permax side effects include:

• nervous system complaints, including involuntary spasms, somnolence (sleepiness), hallucinations, dizziness, and insomnia
• digestive complaints, including nausea, constipation, diarrhea, and indigestion
• respiratory system complaints, including rhinitis (irritation of the nose)
• serious heart valve problems and swelling around the heart and lungs

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Evidence of Permax heart valve damage has increased following a new study published in the March 2007 issue of the medical journal Archives of Neurology. This study provides further support of the problems linked to Permax. Heart valve damage was found to increase with long-term use of the drug. The purpose of this study was to compare Permax patients with those treated with the drugs Mirapex and Requip.

The Federal Drug Administration (FDA) first became aware of Permax heart valve injury problems in 2002. Permax (peroglide) has been on the market since 1989. Permax has been prescribed to treat Parkinson's patients and people suffering from Restless Legs Syndrome. A black box warning was added to the drug's label in 2006 as a result of increasing concern over Permax heart valve damage side effects.

Recent studies were conducted in Britain and Italy to evaluate serious concerns that Permax heart valve damage occurred with long-term use of the drug. In the British study, 11,417 people were given Permax. The test subjects were 37 times more likely to develop heart problems. The Italian study involved 155 Parkinson's patients who were taking Permax. Heart valve damage was reported in 23.4% of the people taking the drug in that study.

The Mayo Clinic has also reported problems with Permax heart valve injury. According to a report by doctors at the Mayo Clinic, three patients who took Permax for three to seven years suffered serious heart valve damage. Two of the patients had significant heart damage requiring valve replacement surgery. The Mayo Clinic doctors recommended that given the dangers associated with Permax, patients with heart problems should not take the drug.

Permax heart valve damage symptoms include chest pain, shortness of breath and swelling of the feet and ankles. In some cases, patients with serious heart valve injuries can require heart valve replacement or if left untreated, the patient may suffer heart failure resulting in death.

Heart valve damage inhibits valves from opening or closing. There are two primary types of heart valve disease. Stenosis (obstruction) occurs when a valve opening becomes narrowed, making it difficult do pump blood throughout the body. Regurgitation (insufficiency) is when a valve is prevented from completely closing causing the blood to leak backward instead of flowing forward.

On March 29, 2007, following the increasing evidence of Permax heart valve damage problems, the FDA announced a Permax recall. In light of the recall, the FDA is prompting patients currently taking the drug to discuss alternative treatment options with their doctor and monitor for possible Permax heart valve injury problems.

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