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Yourlawyer.com (Permax News) http://www.yourlawyer.com/topics/overview/permax Sat, 21 Nov 2009 12:27:24 -0800 pixel-app en FDA Announces Withdrawal of Parkinsons Drug from Market http://www.yourlawyer.com/articles/read/12736 Fri, 30 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12736
The products being withdrawn are Eli Lilly’s Permax (marketed by Valeant Pharmaceuticals) and its generic counterparts made by Par and Teva. Pergolide is a dopamine agonist and is used in conjunction with levodopa and carbidopa to manage the symptoms (tremors, slowness of movement) of Parkinson’s disease. Last year, roughly 12,000 patients in the United States received prescriptions for pergolide products.

“Based on important new drug safety information, FDA has been working with the manufacturers of pergolide products to voluntarily remove these drugs from the market,” said Dr. Douglas Throckmorton, deputy director of FDA’s Center for Drug Evaluation and Research. “The FDA’s increased evaluation of post-market safety is benefiting the public because, in this case, as new data about the product became available, we were able to remove a less safe drug from the market.”

The FDA approved Permax for Eli Lilly in 1988 as “an adjunctive therapy with levodopa” in the treatment of Parkinson’s disease. According to the agency, evidence of the drug’s connection to valvular heart disease first arose in 2002, and a warning about valvulopathy (abnormality of cardiac valves) was added to the product’s label the following year. Last year, the FDA upgraded the alert to a black-box warning, their strongest type of warning, as new evidence poured in about the safety risks associated with pergolide.

According to the FDA, “Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitation is a condition in which valves don’t close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.”

The agency notes that patients should not abruptly stop using pergolide, but instead should consult their physicians to determine alternative therapies that may be available. There are three other dopamine agonists that have not been associated with cardiac-valve abnormalities.]]> Parkinson's drug pulled from market http://www.yourlawyer.com/articles/read/12728 Thu, 29 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12728
The Food and Drug Administration said Thursday that pergolide, sold under the name Permax and also in generic versions, is being withdrawn at the agency's request.

There are other drugs in the same class that can be substituted, Dr. Robert Temple of the FDA's office of drug evaluation said at a briefing.

At least 14 patients have needed to have heart valves replaced, Temple said, adding he believes that is an underestimate.

He estimated that between 12,000 and 25,000 people currently used the drug, which is known as a dopamine agonist.

"Our conclusion is that pergolide has no demonstrated advantage over other therapies," Temple said. "We believe almost all patients can be converted to another drug."

Pergolide came on the market in 1988. Temple said label warnings were added in 2002 after some reports of heart valve problems were received.

In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the labeling for pergolide.

Temple said withdrawal was requested after two recent studies, published in The New England Journal of Medicine, indicated high rates of valve leakage - up to 20 percent - in patients taking the drug.

He said patients should not stop using the drug abruptly, however, urging them to consult their doctor and either switch to another drug or to gradually reduce the amount of pergolide used.

Other dopamine agonists used for Parkinson's disease are not associated with heart valve problems, FDA said.

Pergolide is marketed by Valeant under the trade name Permax and sold and manufactured as the generic drug pergolide by Par and Teva.

Temple said a few people may not be able to change to another drug and the agency is making arrangements to have pergolide available for them.

The new studies also found an increase chance of heart valve damage from another dopamine agonist, cabergoline, sold under the name Dostinex, the FDA said.

Dostinex is not approved in the U.S. for the treatment of Parkinson's disease, but is used at lower doses for other disorders, Temple said. At the lower doses there appears to be little chance of heart problems, the agency said.]]> FDA Announces Voluntary Withdrawal of Pergolide Products http://www.yourlawyer.com/articles/read/12729 Thu, 29 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12729
The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. Pergolide is in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson’s disease.

In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.

There are alternative therapies available for Parkinson’s disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available.

“Based on important new drug safety information, FDA has been working with the manufacturers of pergolide products to voluntarily remove these drugs from the market,” said Douglas Throckmorton, M.D., deputy director of FDA’s Center for Drug Evaluation and Research. “The FDA’s increased evaluation of post-market safety is benefiting the public because, in this case, as new data about the product became available, we were able to remove a less safe drug from the market.”

Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitation is a condition in which valves don’t close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

In light of this additional post-market safety information, the companies that manufacture and sell pergolide will stop shipping pergolide for distribution and, in cooperation with FDA, will withdraw the products from the market.

Permax was approved in 1988 for Eli Lilly and Company as an adjunctive therapy with levodopa in Parkinson’s disease. Valvular heart disease was first described in association with pergolide in 2002. In 2003, FDA asked Lilly to add valvulopathy (abnormality of cardiac valves) to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was sent by Lilly. In 2006, the warning was upgraded to a black box warning, the FDA’s strongest form of warning, because of new data concerning risks of heart valve damage.

FDA today is issuing a Public Health Advisory (PHA) detailing the removal of pergolide products from the market. The PHA, which is available at www.fda.gov/cder/drug/advisory/pergolide.htm includes information and recommended actions for physicians, pharmacists and patients.

The effect of the voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health care providers and patients to discuss appropriate treatment options and time to change treatments.

FDA is working with the manufacturers of pergolide to determine if it might be possible, once the drug is withdrawn from the market, to make the drug available under an Investigational New Drug Application (IND) for those few patients who are currently receiving pergolide and who cannot be successfully converted to other available treatments.
]]> FDA Public Health Advisory Pergolide (marketed as Permax) http://www.yourlawyer.com/articles/read/12730 Thu, 29 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12730
Patients with Parkinson’s disease who are taking pergolide should:

Contact their healthcare professional to discuss alternate treatment options.
NOT stop taking Pergolide 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.

In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the labeling for pergolide. The two recent studies, published in The New England Journal of Medicine in January 2007, confirm earlier studies that also described this problem. Pergolide is marketed by Valeant under the trade name Permax and sold and manufactured as the generic drug pergolide by Par and Teva.

In light of this additional safety information and the availability of alternative treatments for Parkinson’s disease that do not have comparable safety problems, the companies that manufacture and sell pergolide have stopped shipping pergolide for distribution and will, in cooperation with FDA, work to remove from the market both the name brand Permax (pergolide) and the generic versions of pergolide. The effect of this voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for healthcare professionals and patients to discuss appropriate treatment options and to change treatments.

One of the drugs that was included in the recent studies showing increased chance of heart valve problems is Dostinex (cabergoline), another dopamine agonist. This drug is approved in the U.S. for the treatment of hyperprolactinemic disorders (conditions in which there are elevated levels of prolactin in the blood). Dostinex is not approved in the U.S. for the treatment of Parkinson’s disease. For hyperprolactinemic disorders, a considerably lower dose of Dostinex is used. At these lower doses of Dostinex, there appears to be little chance of heart problems; therefore, Dostinex will remain on the US market for the treatment of hyperprolactinemic disorders.

The FDA is working with the manufacturers of pergolide to determine if it is possible to make the drug available to those few patients who are currently taking pergolide where previous efforts to switch to a different treatment have been unsuccessful, or where efforts subsequent to this advisory to switch therapies are also unsuccessful. In the interim, healthcare professionals and patients should consider all treatment options with the understanding that in the future, the drug may no longer be available.
]]> FDA pulls Parkinson's drug http://www.yourlawyer.com/articles/read/12731 Thu, 29 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12731
Officials from the Food and Drug Administration said they asked the marketer of the drug, sold under the brand name Permax, to voluntarily stop sales because of new reports that it can damage heart valves and cause them to leak.

They said the marketer, Valeant Pharmaceuticals International, had agreed to discontinue wholesale distribution.

Permax is in a class of drugs designed to stimulate the brain's production of the neurotransmitter dopamine. It is usually given in combination with other drugs, such as levodopoa.

The agency began warning doctors in 2003 of the possibility for valve damage known as tricuspid regurgitation. New warnings were added last year leading to a "boxed" warning that restricts promotion of the drug.

Two recent reports suggested that the drug raises the risk of valve damage by as much as five times.

Robert Temple, director of FDA's office of medical policy, said the safety concerns, combined with waning use of the drug, caused officials to urge a recall.

"We concluded that it really didn't have a place in therapy anymore," Temple said during a telephone conference call with reporters.

Temple estimated that between 12,000 and 25,000 U.S. patients currently use Permax, known generically as pergolide.

He said patients should not stop taking Permax abruptly but instead should taper off of it with the help of a physician.

"A gradual reduction in dose is the way that should be done," Temple said. The agency said it urged the company to stop wholesale distribution but not pharmacy sales so that patients can continue to use the drug until they switch to different therapy.
]]> Parkinson's meds, valve risk linked http://www.yourlawyer.com/articles/read/12460 Tue, 09 Jan 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12460
The drugs are not the main treatment for Parkinson’s, but one is also sometimes used to treat restless legs syndrome.

A study by Italian researchers found that roughly one-fourth of Parkinson’s patients taking pergolide or cabergoline, sold as Permax, Dostinex and other brands, had moderate to severe heart valve problems. Another study, by German doctors, found that users of either drug were five to seven times more likely to have leaky heart valves than those on other types of Parkinson’s medications. Both studies were reported in Thursday’s New England Journal of Medicine.

“This is an extraordinarily high risk,” said Dr. Bryan Roth, a pharmacology professor at the University of North Carolina at Chapel Hill.

“It’s a bad side effect. As far as I know, there are no medications that can reverse it,” and valve replacement surgery is the only solution, he said.

Roth had no role in the studies but directs a drug screening program for the National Institute of Mental Health. He also published a paper several years ago warning that these drugs appeared to trigger the same heart-related mechanism that the fen-phen diet combination did. The diet pills, sold as Pondimin and Redux, were pulled from the market in 1997 after they were linked to valve problems.

One of the Parkinson’s drugs: pergolide, sold as Permax and other brands also is used to treat restless legs syndrome. Cabergoline, sold as Dostinex, Cabaser and other names, is mostly used in Europe.

About half a million people had taken Permax during its first 14 years on the market when its developer, Eli Lilly and Co., added valve damage to the potential side effects listed on the package insert in 2003. But the company said the risk was extremely low five in 100,000 users.

Roth believed there were more cases, a theory he said the new studies confirmed.

“This is an example of, if you don’t look for it, you don’t see it,” said Dr. C. Warren Olanow, chairman of neurology at Mount Sinai School of Medicine in New York, who had no role in the work. The findings will lead more doctors to prescribe other Parkinson’s treatments, he said.

About 1.5 million Americans and 6 million people worldwide have Parkinson’s disease, which results in tremors, loss of muscle control and sometimes death.

It’s caused by a lack of the brain chemical, dopamine. The main treatment is levodopa, which spurs the body to make more dopamine. Pergolide and cabergoline often are given in addition to that drug or in place of it, especially if symptoms worsen over time.

In one study, Dr. Renzo Zanettini and others at the Instituti Clinici di Perfezionamento in Milan obtained echocardiogram images of the hearts of 155 patients taking various Parkinson’s medications and a comparison group of 90 healthy people.

Moderate to severe valve problems were seen in 23 percent of those on pergolide and nearly 29 percent of those on cabergoline but none of those on other Parkinson’s drugs and less than 6 percent of the comparison group. The study was paid for by the Milan clinic and two Parkinson’s foundations.

In the other study, Dr. Rene Schade and colleagues in Berlin and in Montreal used records from more than 11,400 Parkinson’s patients in the United Kingdom. The rate of newly diagnosed leaky valves was increased among pergolide and cabergoline users but not the others, they found. The Canadian government and a drug company provided partial support for the study. Many researchers in both studies have consulted for Parkinson drug makers.

Pergolide sales have dropped in recent years but still amounted to more than $10 million last year in the United States, according to IMS Health, a health care information firm.

The rights to Permax in the U.S. now belong to Valeant Pharmaceuticals of Aliso Viejo, Calif. A company statement said Permax is safe and effective, but Valeant is no longer promoting the product. All such drugs should be used “with caution,” the statement says.

Cabergoline is approved in the U.S. for treating a hormone problem, excessive prolactin in the blood, but not Parkinson’s.

Roth has been urging companies developing new drugs to test for the mechanism involved in the Parkinson and fen-phen pills, saying those that that have it shouldn’t be sold.]]> Parkinson's Drugs May Have More Risks http://www.yourlawyer.com/articles/read/12454 Mon, 08 Jan 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12454
A study by Italian researchers found that roughly one-fourth of Parkinson's patients taking pergolide or cabergoline, sold as Permax, Dostinex and other brands, had moderate to severe heart valve problems. Another study, by German doctors, found that users of either drug were five to seven times more likely to have leaky heart valves than those on other types of Parkinson's medications. Both studies were reported in Thursday's New England Journal of Medicine.

"This is an extraordinarily high risk," said Dr. Bryan Roth, a pharmacology professor at the University of North Carolina at Chapel Hill.

"It's a bad side effect. As far as I know, there are no medications that can reverse it," and valve replacement surgery is the only solution, he said.

Roth had no role in the studies but directs a drug screening program for the National Institute of Mental Health. He also published a paper several years ago warning that these drugs appeared to trigger the same heart-related mechanism that the fen-phen diet combination did. The diet pills, sold as Pondimin and Redux, were pulled from the market in 1997 after they were linked to valve problems.

One of the Parkinson's drugs; pergolide, sold as Permax and other brands also is used to treat restless legs syndrome. Cabergoline, sold as Dostinex, Cabaser and other names, is mostly used in Europe.

About half a million people had taken Permax during its first 14 years on the market when its developer, Eli Lilly and Co., added valve damage to the potential side effects listed on the package insert in 2003. But the company said the risk was extremely low five in 100,000 users.

Roth believed there were more cases, a theory he said the new studies confirmed.

"This is an example of, if you don't look for it, you don't see it," said Dr. C. Warren Olanow, chairman of neurology at Mount Sinai School of Medicine in New York, who had no role in the work. The findings will lead more doctors to prescribe other Parkinson's treatments, he said.

About 1.5 million Americans and 6 million people worldwide have Parkinson's disease, which results in tremors, loss of muscle control and sometimes death.

It's caused by a lack of the brain chemical, dopamine. The main treatment is levodopa, which spurs the body to make more dopamine. Pergolide and cabergoline often are given in addition to that drug or in place of it, especially if symptoms worsen over time.

In one study, Dr. Renzo Zanettini and others at the Instituti Clinici di Perfezionamento in Milan obtained echocardiogram images of the hearts of 155 patients taking various Parkinson's medications and a comparison group of 90 healthy people.

Moderate to severe valve problems were seen in 23 percent of those on pergolide and nearly 29 percent of those on cabergoline but none of those on other Parkinson's drugs and less than 6 percent of the comparison group. The study was paid for by the Milan clinic and two Parkinson's foundations.

In the other study, Dr. Rene Schade and colleagues in Berlin and in Montreal used records from more than 11,400 Parkinson's patients in the United Kingdom. The rate of newly diagnosed leaky valves was increased among pergolide and cabergoline users but not the others, they found. The Canadian government and a drug company provided partial support for the study. Many researchers in both studies have consulted for Parkinson drug makers.

Pergolide sales have dropped in recent years but still amounted to more than $10 million last year in the United States, according to IMS Health, a health care information firm.

The rights to Permax in the U.S. now belong to Valeant Pharmaceuticals of Aliso Viejo, Calif. A company statement said Permax is safe and effective, but Valeant is no longer promoting the product. All such drugs should be used "with caution," the statement says.

Cabergoline is approved in the U.S. for treating a hormone problem, excessive prolactin in the blood, but not Parkinson's.

Roth has been urging companies developing new drugs to test for the mechanism involved in the Parkinson and fen-phen pills, saying those that that have it shouldn't be sold.]]> Parkinsons Drugs May Lead to Heart Damage http://www.yourlawyer.com/articles/read/12446 Thu, 04 Jan 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12446
In the first study, Italian researchers from the Istituti Clinici di Perfezionamento in Milan conducted an echocardiographic study of the prevalence of valvular abnormalities among 155 patients taking anti-Parkinson’s drugs and compared them to 90 control subjects. They report that the rate of serious valve regurgitation (irregular leaking of blood through faulty heart valves) was much higher in pergolide users (23 percent) and cabergoline users (29 percent) than in users of other Parkinson’s drugs (0 percent) or those not using any medication (6 percent).

In the second study, German scientists used data from the United Kingdom General Practice Research Database to identify 11,417 subjects, ages 40 to 80, who were prescribed anti-Parkinson’s drugs between 1988 and 2005. They found that cardiac-valve regurgitation was five times as likely in cabergoline patients and seven times as likely in patients taking pergolide.

Pergolide and cabergoline are included in a class of drugs known as ergot-derived dopamine agonists. The Italian study said that non–ergot-derived dopamine agonists did not appear to have the same damaging effects as pergolide and cabergoline. Currently, cabergoline is not approved for Parkinson’s treatment in the U.S., but it is prescribed for Parkinson’s treatment in other countries. Pergolide is also prescribed in the treatment of restless leg syndrome.

Permax is already sold with an FDA black-box warning on the label, citing the increased risk of heart valve damage. The Dostinex warning, instituted only last month, is not as strongly worded. Once heart valves are damaged, the only recourse is valve replacement surgery, making the risks associated with the two drugs quite significant.]]> Two Parkinson's drugs linked to valve risk http://www.yourlawyer.com/articles/read/12448 Thu, 04 Jan 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12448
Previous reports of heart-valve disease links led to the drugs being prescribed less frequently, the Wall Street Journal said. Manufacturers said the two drugs should be prescribed with caution.

In a British study, 19 percent of patients taking pergolide or cabergoline suffered heart-valve damage, five to seven times the rate of those who didn't take the medicines.

In Milan, Italy, researchers found heart-valve damage in 23 percent of patients who took pergolide and almost 29 percent for those prescribed cabergoline.

"It's so prevalent in people taking these medications, you kind of wonder why it was missed," said Bryan Roth, director of the National Institute of Mental Health's drug-screening program.

Roth said doctors should stop prescribing the drugs and tell patients to be examined to ensure they don't have valve damage.]]> Parkinson's drugs may have more risks http://www.yourlawyer.com/articles/read/12445 Wed, 03 Jan 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12445
A study by Italian researchers found that roughly one-fourth of Parkinson's patients taking pergolide or cabergoline, sold as Permax, Dostinex and other brands, had moderate to severe heart valve problems. Another study, by German doctors, found that users of either drug were five to seven times more likely to have leaky heart valves than those on other types of Parkinson's medications. Both studies were reported in Thursday's New England Journal of Medicine.

"This is an extraordinarily high risk," said Dr. Bryan Roth, a pharmacology professor at the University of North Carolina at Chapel Hill.

"It's a bad side effect. As far as I know, there are no medications that can reverse it," and valve replacement surgery is the only solution, he said.

Roth had no role in the studies but directs a drug screening program for the National Institute of Mental Health. He also published a paper several years ago warning that these drugs appeared to trigger the same heart-related mechanism that the fen-phen diet combination did. The diet pills, sold as Pondimin and Redux, were pulled from the market in 1997 after they were linked to valve problems.

One of the Parkinson's drugs - pergolide, sold as Permax and other brands also is used to treat restless legs syndrome. Cabergoline, sold as Dostinex, Cabaser and other names, is mostly used in Europe.

About half a million people had taken Permax during its first 14 years on the market when its developer, Eli Lilly and Co., added valve damage to the potential side effects listed on the package insert in 2003. But the company said the risk was extremely low five in 100,000 users.

Roth believed there were more cases, a theory he said the new studies confirmed.

"This is an example of, if you don't look for it, you don't see it," said Dr. C. Warren Olanow, chairman of neurology at Mount Sinai School of Medicine in New York, who had no role in the work. The findings will lead more doctors to prescribe other Parkinson's treatments, he said.

About 1.5 million Americans and 6 million people worldwide have Parkinson's disease, which results in tremors, loss of muscle control and sometimes death.

It's caused by a lack of the brain chemical, dopamine. The main treatment is levodopa, which spurs the body to make more dopamine. Pergolide and cabergoline often are given in addition to that drug or in place of it, especially if symptoms worsen over time.

In one study, Dr. Renzo Zanettini and others at the Instituti Clinici di Perfezionamento in Milan obtained echocardiogram images of the hearts of 155 patients taking various Parkinson's medications and a comparison group of 90 healthy people.

Moderate to severe valve problems were seen in 23 percent of those on pergolide and nearly 29 percent of those on cabergoline but none of those on other Parkinson's drugs and less than 6 percent of the comparison group. The study was paid for by the Milan clinic and two Parkinson's foundations.

In the other study, Dr. Rene Schade and colleagues in Berlin and in Montreal used records from more than 11,400 Parkinson's patients in the United Kingdom. The rate of newly diagnosed leaky valves was increased among pergolide and cabergoline users but not the others, they found. The Canadian government and a drug company provided partial support for the study. Many researchers in both studies have consulted for Parkinson drug makers.

Pergolide sales have dropped in recent years but still amounted to more than $10 million last year in the United States, according to IMS Health, a health care information firm.

The rights to Permax in the U.S. now belong to Valeant Pharmaceuticals of Aliso Viejo, Calif. A company statement said Permax is safe and effective, but Valeant is no longer promoting the product. All such drugs should be used "with caution," the statement says.

Cabergoline is approved in the U.S. for treating a hormone problem, excessive prolactin in the blood, but not Parkinson's.

Roth has been urging companies developing new drugs to test for the mechanism involved in the Parkinson and fen-phen pills, saying those that that have it shouldn't be sold.]]> Study Shows Possible Link Between Parkinsons Medication And Cardiac Valve Disease http://www.yourlawyer.com/articles/read/7976 Thu, 29 Apr 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/7976
Valvular heart disease has been reported by various groups, totaling about 25 patients with Parkinsons disease who take pergolide. "These reports are anecdotal, from uncontrolled case studies," notes study author Richard B. Dewey, Jr., MD, associate professor of neurology, University of Texas Southwestern Medical Center in Dallas. "We were interested to know if this is a rare, idiosyncratic event or a common problem which has until now escaped notice."

Dewey and fellow researchers sent letters to more than 200 patients known to be taking pergolide for Parkinsons disease, and the responders who wished to continue pergolide were urged to undergo echocardiography.

Echocardiograms were performed on 46 patients, and scores for valvular regurgitation (leakage) were compared to an age-matched control group from the Framingham Study (a well-documented heart disease study).

Two outcomes were compared: the presence of abnormal valvular leakage; and the presence of clinically significant leakage using criteria similar to that employed by the FDA in the fenfluramine/ phentermine ("Fen-Phen" diet aid) studies.

Eighty-nine percent (41) of pergolide-treated patients had some degree of valvular insufficiency. In two of three valves for which there is control data (the mitral and aortic), the study showed an approximately two- to three-fold increased risk (odds ratio 3) of regurgitation in the pergolide patients. In the tricuspid valve there was an estimated 14-fold increased risk of significant leakage (odds ratio 18).

"Our study demonstrates that pergolide may injure cardiac valves and, since they are available, consideration should be given to switching patients to an alternate dopamine agonist," concludes Dewey.

The American Academy of Neurology, an association of more than 18,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimers disease, epilepsy, Parkinsons disease, autism and multiple sclerosis. ]]> Draxis Health Inc. Warns of Risk of Heart Valve Problems From Permax Tablets http://www.yourlawyer.com/articles/read/5529 Thu, 17 Apr 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5529
"Of the estimated 500,000 people who have been treated with Permax, or pergolide mesylate) worldwide since 1989, heart valve problems have been reported very rarely, less than one in 20,000 patients," Draxis said in a release. "Symptoms of heart valve problems may vary depending on which valve is damaged, the severity of damage, how quickly the damage occurred and how well the heart adjusts to the increased workload."

Symptoms can include shortness of breath, fatigue, dizziness, chest pain or increased blood pressure, but in some cases patients who develop the problems may experience no symptoms.

People taking Permax who have any of those symptoms or a history of heart problems should contact a doctor. Working with Health Canada, Draxis has also contacted health-care professionals about the warning.]]> Permax Heart Valve Damage Side Effects Lawyer http://www.yourlawyer.com/topics/overview/permax Thu, 17 Apr 2003 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/permax DOWNLOAD OUR PERMAX INFORMATION PACKAGE

Injured by Permax?

Permax Removed From the Market
On March 29, 2007, the FDA announced that Permax (generic: pergolide) is being pulled off the market. There are additional drugs in the same class that can be substituted, Dr. Robert Temple of the FDA's office of drug evaluation said at a briefing. To date, 14 patients have needed to have heart valves replaced, Temple said, adding he believes that is a miscalculation. He estimated that between 12,000 and 25,000 people currently using Permax. Dr. Temple said withdrawal was demanded after two recent studies, published in The New England Journal of Medicine, indicated high rates of valve leakage; up to 20% in patients prescribed Permax.

New Studies Link Permax to Serious Heart Ailments
On January 3, 2007 new studies came out linking Permax with heart valve damage. A study by Italian researchers found that approximately one-fourth of Parkinson's patients taking Permax had moderate to severe heart valve troubles. An additional study, by German doctors, established that users of Permax were five to seven times more likely to have leaky heart valves than those on other types of Parkinson's medications. Both studies can be found in the New England Journal of Medicine.

In the Italian study, Dr. Renzo Zanettini and others at the Instituti Clinici di Perfezionamento in Milan obtained echocardiogram images of the hearts of 155 patients taking various Parkinson's medications and a comparison group of 90 healthy people. Moderate to severe valve problems were seen in 23% of those on Permax. In the German study, Dr. Rene Schade and associates in Berlin and in Montreal used records from over 11,400 Parkinson's patients in the United Kingdom. The rate of newly diagnosed leaky valves was increased among Permax users.

Permax (Generic: pergolide) has been linked to serious heart damage. Cardiac valvulopathy involving one or more valves has resulted in some patients taking Permax. Permax is used to treat Parkinson's disease. The details of the heart valve damage were detailed in a report by doctors at the Mayo Clinic. While the evidence in the report is based only on three cases treated at the clinic, the doctors say their evidence is enough to recommend that anyone with heart problems not take Pergolide, which is sold as Permax and has been used since 1999 to treat the tremors and restless leg syndrome from which Parkinson's disease patients suffer. "Further study is needed to see if this condition is under-recognized or, conversely, so rare that it escapes attention," says Dr. Raul Espinosa, a cardiologist at the Mayo Clinic and one of the authors of the report. But he and his colleagues write in the report that "Pergolide should be discontinued if valvular disease is detected and no other cause identified."

Eli Lilly, the maker of the drug, says that Permax has had a safe record since coming on the market, but that the company would consider adding information about this heart risk to the label. In the cases that were treated at the clinic, three older women aged 61, 72, and 74 had been taking various doses of Permax daily for between three and seven years to treat their Parkinson's symptoms. They were diagnosed with serious valve disease; two required valve replacement surgery. None of the three had a prior history of heart disease. The findings led doctors back to their surgical records to see if any other people who had had valve replacement in the previous year had also been taking Pergolide. They found one out of 17 patients who had been on the drug. At the same time, a third woman came to the Mayo Clinic with the same diagnosis of valve disease and with a history of taking Pergolide for her Parkinson's.

Dr. Abraham Lieberman, the medical director of the National Parkinson Foundation in Miami, was one of the doctors who studied Pergolide in the 1980s when it was developed. "There is evidence of pulmonary fibrosis that is associated with Pergolide," he says, "but there's a 14-year history of people taking Permax, and why hasn't this showed up sooner?"

Parkinson's disease is a progressive neurological disorder resulting from the degeneration of neurons in a region of the brain that controls movement. The degeneration creates a shortage of the brain-signaling chemical known as dopamine, causing the movement impairments that characterize the disease. In the United States, at least 500,000 people are believed to suffer from Parkinson's disease, and about 50,000 new cases are reported annually, according to the National Institute of Neurological Disorders and Stroke.

Legal Rights for users of Permax
If you or a loved one took Permax and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified defective drugs attorney.
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