Yourlawyer.com (Heart Valve Disease News)

Parkinson's meds, valve risk linked

Tue, 09 Jan 2007 00:00:00 -0800

The risk of heart valve damage with two drugs for Parkinson’s disease may be far greater than was known, new research suggests.

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

Mon, 08 Jan 2007 00:00:00 -0800

The risk of heart valve damage with two drugs for Parkinson's disease may be far greater than was known, new research suggests. 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.

Parkinsons Drugs May Lead to Heart Damage

Thu, 04 Jan 2007 00:00:00 -0800

Two new studies published in today’s New England Journal of Medicine have called into question the safety of two specific medications prescribed for Parkinson’s disease. The two drugs cited Valeant Pharmaceuticals’ Permax (pergolide) and Pfizer’s Dostinex (cabergoline) have been shown to lead to an increased risk of heart valve damage in Parkinson’s patients, but the new studies indicate that the risk of valve damage may be higher than previously thought.

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

Thu, 04 Jan 2007 00:00:00 -0800

Two drugs used for Parkinson's disease increase the risk of heart-valve damage, studies said, prompting a U.S. official to call for a halt in their use. Patients who took pergolide or cabergoline are four to seven times as likely to suffer heart-valve damage as patients who did not, two studies in Thursday's New England Journal of Medicine found.

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

Wed, 03 Jan 2007 00:00:00 -0800

The risk of heart valve damage with two drugs for Parkinson's disease may be far greater than was known, new research suggests. 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.

Doctors Say Fen-Phen Causes Heart Disease

Tue, 08 Jul 1997 00:00:00 -0700

Fen-Phen, a powerful diet drug taken by 18 million Americans each year, can cause heart disease in otherwise healthy patients, Mayo Clinic researchers said.

"Our conclusion is simple," Dr. Heidi Connolly of the Mayo Clinic said at a news conference Tuesday. "We are concerned that the Fen-Phen combination may have important implications regarding heart valve disease."

The preliminary finding, which was unexpected, will be published in the August 28 edition of New England Journal of Medicine. In an unusual move, the editors of the journal decided to release the information early given the impact on public health.

The preliminary finding, which was unexpected, will be published in the August 28 edition of New England Journal of Medicine. In an unusual move, the editors of the journal decided to release the information early given the impact on public health.

At the same time, the Food and Drug Administration began sending letters to thousands of doctors asking them to immediately check fen-phen patients for valve problems and report them to the agency.

The urgency with which the journal and the government treated the information was unusual and reserved for only the most serious public health matters.

Connolly, the chief author of the report, stressed that the findings were preliminary and that "more information is needed." But she urged users of the drug to take precautions.

"It's really important that patients discuss these findings with their physicians and weigh risks and benefits," she said.

Added Dr. Donald Hensrud, a co-author of the report: "This new information adds a little bit more to the risk side of things."

Fen-Phen is a combination of two drugs -- fenfluramine, an appetite suppressant, and phentermine, a mild stimulant. When combined they create a powerful diet drug. In 1996, there were 18 million prescriptions written for Fen-Phen in the United States.

Although both fenfluramine and phentermine are FDA-approved, their combination is not. That is because ingesting the two together does not fall under FDA control.

Midwest women examined

The study documents the cases of 24 women living in the upper Midwest who had no history of heart problems. The women took Fen-Phen for six to 18 months and experienced a deterioration in the valves of their hearts.

Five of them had open-heart surgery to replace damaged or leaking valves. When the surgeons examined the defective valves they discovered the valves were covered with an unusual white coating. The valve damage caused blood to leak back into the heart, making it work harder.

"None of the patients have died. However, many have developed serious cardiovascular diseases requiring either medication or surgery," Connolly said. The valve damage also may diminish life expectancy, she said.

Although most of the women sampled were overweight, researchers discounted obesity in the results. "I've not seen any association with obesity as a primary cause of valvular heart disease. ...I don't think obesity has any factor," said Dr. Jack Crary.

Heart-valve deterioration is considered a serious condition that sometimes requires surgery. It can be a silent condition causing no symptoms for years until it becomes severe. If untreated it can lead to congestive heart failure.

Not the only side effect

Before Tuesday's announcement, primary pulmonary hypertension, a serious lung disease, was the only known serious side effect of Fen-Phen. Pulmonary hypertension is a disorder in which the arteries supplying the heart have an abnormally high blood pressure. Patients become short of breath, and heart failure can follow, then death.

Connolly said she and her associates conducted the research because they noticed a pattern of heart damage in patients taking the drug.

"We began to notice that otherwise healthy young women, presenting with this unusual form of valve disease, were also on Fen-Phen," Connolly said.

On routine doctor visits, the women were found to have cardiovascular symptoms or heart murmurs after having taken the weight-loss medications for an average of one year.

"We don't know how Fen-Phen may cause injury to the heart valves," Connolly said. "We do know that fenfluramine and phentermine alter the way the brain chemical serotonin is metabolized, and serotonin that circulates in the blood can cause [heart] valve injury."

Heart Valve Disease Drug Injury Lawyer

Tue, 08 Jul 1997 00:00:00 -0700

Heart Valve Disease

Heart valve disease occurs when the valve cannot open all the way because of disease or injury, so blood has a hard time flowing to the next heart chamber. Or the value does not close completely, and blood leaks backwards. As a result, the heart has to work harder to pump blood or blood may back up in the lungs or lower body.

The cause of valve disease can be a childhood attack of rheumatic fever, a bacterial infection or an injury to the heart. Some people are born with a valve that does not work properly, or the valves may wear out with the aging process. A variety of other problems, including coronary artery disease (blockages in the coronary arteries of the heart), can sometimes cause valve problems.

The heart has two halves, a left and a right, each with two chambers, the atrium and the ventricle. Between the chambers are the heart valves, which ensure that the blood runs only in one direction. There are also heart valves situated between the ventricles and the major arteries the aorta and pulmonary artery - where they have the same function. Failure in a valve in the left side of the heart the aortic or the mitral valve results in left-sided heart failure. This leads to an accumulation of fluids in the lungs, or pulmonary oedema.

Valve diseases of the right side of the heart, the pulmonary and tricuspid valve, is rare but can occur as the result of some forms of congenital heart disease or long-term left-sided heart failure. Right-sided heart failure is characterized by fluid accumulation in the body, particularly in the legs, abdominal cavity and the liver. Malformation of the heart valves can be divided into two categories: narrowed (stenosed) valves and leaking (regurgitant) valves or a combination of both.

Causes of Heart Disease:

congenital abnormality
degeneration through atherosclerosis (aortic stenosis only)
damage from rheumatic fever
excessive calcification in old age (aortic stenosis only)
bacterial infection or inflammation of a valve
excessive floppiness of the leaflets (mitral valve prolapse)
enlargement of the heart or aorta, the main blood vessel into which the left ventricle pumps

If you or a loved one has taken prescription medications and been diagnosed with Heart valve disease, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.