http://www.yourlawyer.com/topics/overview/dostinex Sat, 21 Nov 2009 18:15:21 -0800 pixel-app en http://www.yourlawyer.com/articles/read/14843 Tue, 29 Jul 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14843 Mirapex seemed to be a miracle.  It offered the promise of stopping the tremors many had experienced or decades.  Unfortunately, it is now apparent that Mirapex and similar drugs cause bizarre behavior in some users - with some developing gambling problems, heightened sexual interest or compulsive spending and eating habits where there had previously been no sign of compulsive behavior.  

This week, the first of three "bellweather" trials concerning Mirapex and its alleged linkage to compulsive gambling is underway in U.S. District Court in Minneapolis.  More than 200 people are suing Boehringer Ingelheim Pharmaceuticals, the maker of Mirapex, over compulsive behavior they say it caused.   These first three trials will be used by many legal experts to gauge the strengths and weaknesses of those cases.

People with Parkinson's lack dopamine in key areas of the brain.   Mirapex and drugs like  it are known as a dopamine agonist, and they work by mimicking the effects of this vital hormone and neurotransmitter.  Other dopamine agonists include Requip, Parlodel, Dostinex Apokyn and Neupro.

For years, people taking Mirapex and similar drugs have complained about problems with compulsive behavior.  Most of those complaints involved people who had no history of compulsive behavior before they started dopamine agonist therapy, and most reported that the behavior stopped as soon as they quit using the drugs.  Several small studies, including one published in 2005 by Mayo Clinic researchers, found a link between the drugs and compulsive behavior, especially gambling addiction.   The drugs' labeling also includes warnings about possible compulsive behavior.

In June, results from the largest study ever to investigate the connection between compulsive behavior and dopamine agonists was presented at the at the International Congress of Parkinson's Disease and Movement Disorders conference in Chicago.  That study found that more than 13 percent of patients taking dopamine agonists, sold under brand names suffer from at least one of four serious behavioral addictions.  

The study, which looked at more than 3,000 patients from 46 medical centers in the United States and Canada, found that Parkinson's patients on dopamine agonists are nearly three times more likely to have at least one impulse-control disorder compared with patients receiving other treatments.  

The growing evidence that Mirapex and other similar drugs are linked to compulsive behavior has changed the way some doctors approach these medications.  Dr. Eric Ahlskog, a neurologist at the Mayo Clinic who has treated Parkinson's patients for 25 years, told The Chicago Tribune that he no longer is comfortable starting patients on dopamine agonists after three patients in his practice last year developed significant gambling and sexual problems.

Other doctors told the Tribune that while they still treat patients with dopamine agonists, they are using smaller doses.  Many are also now asking the patients they treat with the drugs and their families about compulsive behaviors as part of routine patient checkups.

]]> 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.]]> 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.]]> 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.]]> 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.]]> 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.]]> 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.]]> http://www.yourlawyer.com/topics/overview/dostinex Wed, 03 Jan 2007 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/dostinex Dostinex Linked to Heart Valve Disease New Studies Link Dostinex to Serious Heart Ailments
On January 3, 2007 new studies came out linking Dostinex with heart valve disease. A study by Italian researchers found that roughly one-fourth of Parkinson's patients taking Dostinex had moderate to severe heart valve troubles. An additional study by German doctors established that users of Dostinex 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 29% those on Dostinex. 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 Dostinex users.

Dostinex (generic: cabergoline) manufactured by Pfizer Inc., gained approval by the FDA on December 23, 1996. Dostinex is used for Parkinson’s in other countries but is approved in this country only for a hormonal disorder, hyperprolactinemia.

Dr. Michael Berelowitz, senior vice president of Pfizer, which makes Dostinex, said the company had received fewer than 100 reports of valve problems from the drug, mostly in people with Parkinson’s. The two new reports involve only Parkinson’s. The results should not be applied to patients who take Dostinex for the hormone disorder, because they take far smaller doses of the drug than do patients with Parkinson’s, said Dr. David L. Kleinberg, a professor of medicine and director of the neuroendocrine unit at New York University’s medical school. Many doctors consider it the best drug for the problem. People with Parkinson’s often take doses 20 to 40 times as high.

Dostinex sales in the United States totaled about $88 million in 2005, and about 87,000 prescriptions were written, according to Wolters Kluwer Health, an information company in the Netherlands.

Legal Rights for Dostinex Users
If you or a loved one took Dostinex and you suffered heart valve damage or any other serious side effects, please fill out the form at the right for a free case evaluation from a qualified defective drug attorney.]]>