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.
After Heart Valve Replacement
Since Permax was approved in 1988, 12,000 to 25,000 patients have been prescribed the drug to treat the symptoms associated with Parkinson's. Permax is primarily used to treat Parkinson's patients during the early stages of the disease. Recent studies have revealed Permax heart valve disease problems in Parkinson's patients following long-term use of the drug.
Men and women are affected by Parkinson's disease in almost equal numbers. Parkinson's disease is the most commonly diagnosed neurodegenerative disorder after Alzheimer's. According to the National Institute of Neurological Disorders and Stroke, around 50,000 new Parkinson's Disease cases are reported annually. Since its approval doctors have prescribed Permax to over 500,000 Parkinson's and Restless Legs Syndrome patients.
Parkinson's symptoms are characterized in four primary ways:
• rest tremor of a limb (shaking with the limb at rest)
• rigidity (stiffness of the limbs and trunk)
• slowness of movement (bradykinesia)
• postural instability (poor balance)
Permax (peroglide) is a member of a class of drugs referred to as dopamine agonists and is used to help treat symptoms of Parkinson's disease. Most Parkinson's symptoms are caused by a lack of dopamine. Medications such at Permax are used to treat Parkinson's by attempting to mimic dopamine which helps improve the symptoms associated with Parkinson's disease.
Recent studies have shown an increased risk of Permax heart valve disease in Parkinson's patients who have taken the drug over a long period of time. A new Permax study, "Cardiac Valve Regurgitation With Peroglide Compared With Nonergot Agonists in Parkinson Disease", was published in the March 2007 issue of the medical journal Archives of Neurology. This study involved Parkinson's patients and showed an increased risk of Permax heart valve disease following long-term use of the drug. Two other Permax studies conducted in Britain and Italy also revealed a significant increase in Parkinson's patients developing heart valve disease. Permax valve injuries were found in around one-fourth of Parkinson's patients taking the drug.
In 2006 a black box warning was added to the Permax label following serious concerns of heart valve disease risks in Parkinson's patients taking the drug. On March 29, 2007 the FDA announced a Permax recall after more studies revealed increasing evidence of Permax heart valve disease in Parkinson's patients. The FDA stated that the withdrawal of Permax from the marketplace would not be immediate in order to allow time for doctors and patients to discuss appropriate alternative treatment options.
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