The Bitter Pill

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April 2007 Big Pharma Litigation Update – Drugs – Part II

Evelyn Pringle April 12, 2007

The anti-epileptic drug, Depakote (valproate), marketed by Abbott Laboratories, is one of the most heavily prescribed medications for off-label use. Experts say the evidence of harm caused by Depakote is just beginning to emerge.

According to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski, a recognized expert on psychotropic drugs, “we can anticipate a continuing series of tragic outcomes from the massive overuse of Depakote, secondary not only to birth defects and death, but also due to anemias, hepatic disease, obesity, diabetes type II, pancreatitis and other serious systemic and neurological dysfunctions.”

Bayer is under fire for hiding the adverse effects of the anti-clotting drug, Trasylol, used in heart surgery, and will no doubt be hit with plenty of lawsuits in the not to distant future, considering that Dr Dennis Mangano, the lead author of new study in the February 7, 2007, Journal of the American Medical Association, says that the Trasylol may be responsible for 10,000 deaths over five years.

On December 15, 2006, the FDA announced new labeling for Trasylol, and said a study suggests that, in addition to serious kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes.

Because Trasylol is administered during surgery, many victims may not even realize they have been injured by the drug. But plenty have, according to Dr Mangano, who says that in 2006, Trasylol, was administered to 246,000 patients.

Another drug on the legal chopping block is the Parkinson’s drug, Permax. As far back as December 2002, doctors at the Mayo Clinic reported heart valve disease in 3 patients who had been taking Permax, similar to damage caused by the Fen-Phen combination.

In 2004, HealthDay News reported that a study had confirmed previous findings that the drug could damage heart valves and surgery would be needed to correct it. Two new studies in the January 4, 2007, New England Journal of Medicine, report that the number of Permax patients who have developed valve damage is higher than expected.

One study, which included 155 patients taking various Parkinson’s drugs, and 90 healthy patients in a comparison group, and found moderate to severe valve problems in more than 23% of the patients on Permax, compared to less than 6% in the comparison group.

The second study found Permax users were 5 to 7 times more likely to have leaky heart valves than patients taking other types of Parkinson’s drugs, and patients taking the highest doses of Permax had a 37 times greater risk.

“This is not a rare side effect,” says Dr Bryan Roth, a professor at the University of North Carolina, who wrote an editorial accompanying the reports in the NEJM.

“That’s an extraordinarily high incidence,” he warns. “That makes this a serious problem.”

Heart valve damage is a life-threatening condition and costly to treat. Replacement requires open heart surgery, where the breastbone is divided, the heart is stopped, and blood is sent through a heart-lung machine, according to the Texas Heart Institute. No drug can reverse valve damage, making replacement surgery the only option. Medical experts are advising all Permax patients to undergo testing for valve damage.

The drug was introduced to the US market by Eli Lilly, but Valeant Pharmaceuticals now sells Permax. On March 29, 2007, Permax was pulled off the market after the FDA reviewed new information that associates it with heart problems.

During the last 2 decades, the antidepressants, known as selective serotonin reuptake inhibitors, or SSRIs, have been prescribed for more unapproved uses than any other class of drugs in history. A June 2005, study in the Journal of Clinical Psychiatry, found that 75% of SSRI prescriptions written were for unapproved uses.

SSRIs have now been linked to suicidality, extreme violence and homicide, several life-threatening birth defects, abnormal uterine or gastrointestinal bleeding, a decrease in bone mineral density, fertility problems, sexual dysfunction, and a severe withdrawal syndrome.

On April 10, 2004, the British Medical Journal, criticized the authors of studies on SSRI’s for exaggerating the benefits and downplaying the harm, including suicidality, and discussed a study of 93 children on Paxil that produced 11 serious adverse events, including 7 hospitalizations, compared to only 2 in children in the placebo group.

The Paxil suicide risk is not limited to children. An August 22, 2005, study by Norwegian researchers of over 1,500 adults, found 7 Paxil patients attempted suicide compared to only 1 attempt in the group on a placebo, and recommended that warnings not to prescribe Paxil to children should also apply to adults.

According to Forest Lab’s Annual Report filed on June 14, 2006, the company is a named defendant in approximately 25 lawsuits, with the majority involving the company’s top selling SSRI drugs, Celexa or Lexapro, for inducing suicidality.

A wrongful death lawsuit was filed in September 2005, by the Pogust & Braslow law firm in Conshohocken, Pennsylvania, on behalf of the family of 32-year-old man who unexpectedly committed suicide soon after being prescribed Lexapro.

A steady stream of lawsuits have been filed against GlaxoSmithKline over Paxil, stemming from the company’s concealment of the drug’s link to suicide, birth defects, violence and withdrawal syndrome.

On March 23, 2006, the California-based Baum Hedlund law firm filed a national class-action lawsuit against Glaxo on behalf of the mother of an 11-year old Kansas boy who committed suicide, and a teenager in Texas who attempted suicide while taking Paxil.

She says, Baum Hedlund has documents obtained in litigation that show there was an awareness of the suicide risk as far back as the late 1970’s, a decade before the first SSRI was approved for sale in the US.

A new round of Paxil lawsuits began on October 16, 2006, when Baum Hedlund filed a case alleging that Paxil use during pregnancy resulted in an infant being born with a life-threatening lung disorder, PPHN. Between 10% and 20% of infants born with PPHN end up dying, even when they receive treatment.

On July 28, 2006, Baum Hedlund also filed a lawsuit on behalf of the parents of an infant who was born with congenital heart birth defects as a result of his mother taking Paxil during pregnancy. Since birth, the child has undergone 3 open-heart surgeries and will likely have to undergo more and possibly a heart transplant at some point in the future.

Based on the company’s legendary history of concealing adverse effects, the lead attorney on the case, Karen Barth Menzies, says believes Glaxo has known about these risks and should have warned prescribing doctors and consumers about these birth defects long ago.

The Houston law firm of Robert Kwok & Associates is handling a Celexa birth heart defects case in Kentucky. The mother was prescribed Celexa during pregnancy, and her baby was born with Shone’s Complex, a form of congenital heart disease that consists of defects that lead to the obstruction of blood flow from the heart to the body.

Legal analysts are predicting that SSRI makers will offer early settlements in cases involving birth defects to avoid having these families appear before a jury.

Pfizer is still being sued left and right over adverse effects related to the epilepsy drug Neurontin. In 2004, the company pleaded guilty to charges involving a massive off-label marketing scheme and agreed to pay the second-largest settlement ever in a health care fraud prosecution of $403 million. By 2002, a full 94% of Neurontin sales were for off-label use, according to the August 16, 2004 USA Today.

Many private lawsuits involve Neurontin-induced suicidality. The Pogust & Braslow law firm is handling a case for Natalie Biedenbender, whose husband committed suicide at age 39, after being prescribed the drug off-label for back pain.

“Although Neurontin is prescribed for scores of off-label indications,” Attorney Derek Braslow reports, “since 1999, the off-label use continues to be most common in the areas where the company focused its illegal marketing efforts, such as bipolar disorder, peripheral neuropathy, and migraine.”

Two lawsuits were recently filed against Novartis and Astellas Pharma, the makers of the topical skin creams, Elidel and Protopic, used to treat eczema. Alan and Dayna Thomson filed a lawsuit in December 2006 after their daughter Haley died after using Elidel, and Ashley McDonald filed a lawsuit in January 2007 after being diagnosed with lymphoma following her use of Elidel.

In another case, Traci Reilly, of Naperville, Illinois, developed breast cancer after applying Protopic and Elidel for a condition that caused patches of discolored skin on her breast.

Protopic and Elidel belong to a class of drugs known as calcineurin inhibitors, so called because they reduce immune activity by inhibiting the activity of the enzyme calcineurin in organ transplant patients. Use of these drugs has long been known to increase the risk of cancer, and the drugs were labeled accordingly for use in transplant patients.

Protopic and Elidel have only been on the market for about 5 years and together have already been prescribed to more than 7 million people. In 2006, the FDA added a black box warning to the skin creams about the cancer risk.

On February 21, 2007, Tom Moore, the author of several books on the pharmaceutical industry, told CBS News that he had studied about 1,200 cases of suspected injuries pertaining to Protopic and Elidel reported to the FDA through 2005 and found more than 100 potential cancer cases in children and adults, with most involving lymphoma or skin cancer.

Filed under: 2007, addict, Birth Defects, cancer, Depakote, Elidel, Neurontin, Permax, SSRIs, suicide, Trasylol

Experts Predict Many Cases of Permax Heart Valve Damage

Evelyn Pringle January 21, 2007

Nearly three years ago, HealthDay News reported that a study had confirmed previous findings that the drug, Permax, used to treat Parkinson’s disease, could damage heart valves and surgery would be needed to correct the problem.

The April 28, 2004, report quoted the lead researcher, Dr Richard Dewey Jr, an associate professor from the University of Texas Southwestern Medical Center, as saying he believed the drug should be taken off the market.

Permax (pergolide) belongs to a class of drugs known as dopamine agonists. Dopamine helps regulate movement and balance. People with Parkinson’s suffer from a shortage of dopamine and Permax stimulates nerves in the brain that would normally be stimulated by dopamine. The drug has also been prescribed to treat restless leg syndrome.

Two years earlier, in December 2002, doctors at the Mayo Clinic reported heart valve disease in three patients who had been taking Permax for several years, similar to the damage found in patients who took the Fen-Phen diet drugs.

The 3 cases involved women aged 61, 72, and 74, with no history of heart disease, who had been taking Permax for between three and seven years to treat Parkinson’s symptoms. They were all diagnosed with serious valve disease and two required replacement surgery.

As a follow-up to the earlier reports of valve damage in Permax patients, Dr Dewey, and his fellow researchers sent out 200 letters to people who were known to be taking Permax for Parkinson’s to determine whether the reports were isolated cases or a common side effect of the drug, and to suggest that patients should switch to anther drug. Patients who wanted to continue taking Permax were urged to have an echocardiogram, to check for heart valve damage.

For the Dewey study, echocardiograms were performed on 46 patients, and then compared the test results from a similarly-aged healthy comparison group. The study found that 89% of the patients receiving Permax had evidence of leaky heart valves, called valvular insufficiency, and Permax patients were up to 18 times more likely to have significant leakage in at least one valve, than patients in the comparison group.

Blood is pumped through the heart in only one direction, according to the Texas Heart Institute. Heart valves play a key role in this one-way blood flow, opening and closing with each heartbeat. Pressure changes on either side of the valves cause them to open their flap-like “doors” at just the right time, then close tightly to prevent a backflow of blood. There are 4 valves in the heart:

* Tricuspid valve
* Pulmonary valve
* Mitral valve
* Aortic valve

Valvular insufficiency occurs when the heart valves do not close properly. It forces the heart to work harder to circulate the blood and can lead to serious problems such as heart attack or heart failure, according to WebMD. Symptoms of heart valve disease include:

* Shortness of breath and/or difficulty breathing
* Weakness or dizziness
* Chest pain or pressure
* Heart palpitations
* Swelling of ankles, feet, or abdomen
* Rapid weight gain

Two new studies published in the January 4, 2007, New England Journal of Medicine, report that the number of Parkinson patients on Permax who have developed heart valve damage is higher than expected.

In one study titled, “Dopamine Agonists and the Risk of Cardiac-Valve Regurgitation,” researchers led by Dr Renzo Zanettini, in Milan, Italy obtained echocardiograms from 155 patients taking various Parkinson’s drugs, and 90 healthy patients for a comparison group.

The study found moderate to severe valve problems in more than 23% of the patients receiving Permax compared to less than 6% of the patients in the comparison group.

The second study found that Permax users were five to seven times more likely to have leaky heart valves than patients taking other types of Parkinson’s drugs, and patients taking the highest doses of Permax had a 37 times greater risk of valve damage. In this study, Dr Rene Schade and colleagues in Berlin and Montreal reviewed records from over 11,400 patients with Parkinson’s disease in the UK.

“This is not a rare side effect,” says Dr Bryan Roth, a pharmacology professor at the University of North Carolina, who wrote an editorial accompanying the reports in the NEJM. “That’s an extraordinarily high incidence,” he warns. “That makes this a serious problem.”

Experts note that there are no medications that can be used to reverse valve damage and replacement surgery is the only solution.

Dr Roth published a paper several years ago warning that Permax appeared to trigger the same heart valve problems as the Fen-Phen combination of the drugs, Pondimin and Redux, which were pulled off the market in 1997, after they were linked to valve disease.

The findings of the new Permax studies could potentially represent a public health crisis. The drugs, available in generic form from a variety of producers, “have been around a long time, and a large number of people have potentially been exposed to them,” said Dr Michael Okun, medical director of the National Parkinson Foundation, in the January 4, 2007 LA Times.

Permax came on the market in the US about 14 years ago, and an estimated half million people had already taken the drug by the time its maker, Eli Lilly, added valve damage to the side effects listed on the labeling in late 2003. The warning included the statement: “Some patients have required valve replacement, and deaths have been reported,” but at the same time, Lilly claimed that the problem only occurred in five out of every 100,000 Permax users.

The drug is now marketed in the US by Valeant Pharmaceuticals.

Heart valve damage is an extremely serious medical condition that is both life-threatening and costly to treat. During valve replacement surgery, the breastbone is divided, the heart is stopped, and blood is sent through a heart-lung machine. Because the heart or aorta must be opened, it requires open heart surgery, according to the Texas Heart Institute.

The two kinds of valves used for replacement surgery are mechanical valves made from materials such as plastic or metal, and biological valves made from animal tissue or human tissue from a donated heart.

Mechanical valves are stronger and last longer but because blood tends to stick to them and create blood clots, patients need to take blood-thinning drugs for the rest of their lives. And because these medicines increase the risk of bleeding within the body, patients must always wear a medical alert bracelet so medical professionals will know they are taking a blood-thinning medication.

Patients with biological valves usually do not have to take blood-thinning drugs but because the valves are not as strong as mechanical valves patients may need have the valve replaced every 10 years.

Following surgery, a patient can expect to stay in the hospital for about a week, including at least 1 to 3 days in the Intensive Care Unit, the Texas Institute says. Patients with an office job, can usually go back to work in 4 to 6 weeks but those with more physically demanding jobs may need to be off work longer.

In addition to switching to another drug to treat Parkinson’s disease, medical experts are advising all Permax patients to undergo testing to check for heart valve damage.

Filed under: 2007, Eli Lilly, FDA, Permax

FDA Finally Yanks Permax Off the US Market

Evelyn Pringle April 4, 2007

On March 29, 2006, the FDA withdrew Permax (pergolide) from the market because it increases the risk of valvular heart disease. Permax belongs to a class of drugs known as dopamine agonists that help regulate balance and movement in Parkinson’s patients who suffer from a lack of dopamine.

When Permax was FDA approved in 1988, Eli Lilly marketed the drug, but in the US today, the drug is manufactured by Valeant Pharmaceuticals and generic versions are sold by Par and Teva. According to IMS Health, a prescription drug tracking firm, more than 72,000 prescriptions for the drug were written in 2006.

The decision by the FDA to take Permax off the market came after 2 recent studies were published in the New England Journal of Medicine in January 2007, that confirmed previous studies that linked Permax, and another drug prescribed to treat Parkinson’s disease, Dostinex, to heart valve disease.

Dostinex is marketed by Pfizer, and is approved to treat Parkinson’s patients in other countries. However, the drug has only been approved to treat the hormonal disorder, hyperprolactinemiam in the US, which means any prescriptions for Dostinex written for Parkinson’s patients in this country were off-label, because the drug has never passed the required FDA approval process to demonstrate that it is safe and effective in treating patient’s with Parkinson’s disease.

The NEJM studies did not assess patients who were taking Dostinex for the hormonal disorder, and according to Dr Shlomo Melmed, an endocrinologist and a senior vice president of Cedars-Sinai Medical Center in Los Angeles, in the January 4, 2007, New York Times, tens of thousands of people in the US, mostly women, have taken the drug for hyperprolactinemiam.

Experts say the valve damage is not likely to be profound in patients treated for the hormone disorder because lower doses of Dostinex are used compared to Parkinson’s patients, but Dr Melmed told the Times that men can develop the condition and may need higher doses, so those men should be monitored for heart valve damage.

In 2003, Eli Lilly first added the risk of heart valve damage to the Permax label but by then an estimated half million people had already taken the drug. Although the warning stated: “Some patients have required valve replacement, and deaths have been reported,” Lilly said at the time that only 5 out of 100,000 patients developed valve damage.

The company also sent out a Dear Dr letter to prescribing doctors to warn about the increased risk in 2003, but the FDA did not add a black box warning about valve damage to the label on Permax until 2006. A “precaution” was also added to the label of Dostinex in December 2006.

Heart valve damage is a life-threatening condition that can lead to heart failure and sudden death. It cannot be treated with medication and open heart surgery for valve replacement is the only option available for patients with valve disease.

The surgery itself is complex, costly, and life-threatening. According to the Texas Heart Institute, for valve replacement surgery, the breastbone must be divided, the heart stopped, and blood must filtered through a heart-lung machine.

Following surgery, the Institute says, patients must be maintained in the Intensive Care Unit for one to 3 days, and patients typically remain hospitalized for about a week.

There are 2 types of valves used for replacement. Mechanical valves, which are made with plastic or metal, and biological valves which are made with animal tissue or human tissue from a donated heart.

Experts say, mechanical valves last longer than biological valves but blood tends to stick to devices, causing blood clots to form and patients often need to take a blood-thinning drug for life. Because blood thinners are known to increase the risk of bleeding within the body, patients taking the drugs must wear a medical alert bracelet at all times so medical professionals will know they are on the medication.

Patients with biological valves are usually not required to take blood-thinners but these valves are not as sturdy as the mechanical valves and often need to be replaced every 10 years.

According to FDA officials, to date the agency is aware of at least 14 cases where patients have required replacement surgery, but Dr Robert Temple of the FDA’s office of drug evaluation, said at a briefing that 14 is likely to be an underestimate.

The FDA has consistently acknowledged on may occasions that only between 1% and 10% of all adverse events associated with prescription drugs are reported through the agency’s data tracking system which means the actual number of patients with valve damage is bound to be much higher.

The FDA was made aware of the link between Permax and valve disease more than 5 years ago, when doctors at the Mayo Clinic reported in 2002, that 3 patients who had no history of heart disease had developed valve damage after taking Permax for several years and 2 had required replacement surgery to correct the problem.

This discovery led the doctors to review surgery records to determine whether any of the other 17 patients who had undergone valve replacement in the previous year had been taking pergolide and found that one other patient who required surgery had been on drug.

In 2004, as a follow-up to previous reports of valve disease, researchers led by Dr Richard Dewey Jr, an associate professor from the University of Texas Southwestern Medical Center, sent 200 letters to Parkinson’s patients who were known to be on Permax to determine whether the earlier reports of valve damage were isolated cases.

For this study, echocardiograms were performed on 46 patients, and then compared to the results of a similar-aged healthy comparison group. The researchers determined that 89% of the Permax patients had evidence of leaky heart valves, and were up to 18 times more likely to have significant leakage in at least one valve than patients in the control group.

After the study was released, on April 28, 2004, HealthDay News reported that Dr Dewey recommended that Permax should be taken off the market back then.

In the two new studies in the New England Journal of Medicine, researchers note that the number of patients who developed heart valve damage is higher than previously expected.

One study conducted in Milan, Italy, titled, “Dopamine Agonists and the Risk of Cardiac-Valve Regurgitation,” led by Dr Renzo Zanettini, obtained records of echocardiograms for 155 patients taking the Parkinson’s drugs, and compared them to the records of 90 healthy patients in another group.

After analyzing the records, the researchers found moderate to severe valve damage in more than 23% of the Permax patients and 29% of Dostinex patients compared to less than 6% of the patients in the comparison group.

The second study, conducted by Dr Rene Schade and colleagues in Berlin and Montreal, analyzed records from more than 11,400 patients in Great Britain, between the ages of 40 to 80 who were prescribed the drugs between 1988 and 2005, and determined that Permax patients were 7 times more likely to have leaky heart valves and Dostinex patients were 5 times more likely to have valve damage, when compared to patients in the control group.

This second study also showed that Permax patients on the highest doses of the drug had a 37 times greater risk of developing valve disease, and at higher doses, Dostinex patients were over 50 times more likely to develop damage.

Dr Bryan Roth, a professor at the University of North Carolina School of Medicine and director of the psychoactive drug screening program at the National Institute of Mental Health, wrote an analysis that accompanied the studies in the NEJM, and said the drugs cause the same valve damage as Wyeth’s fen-phen diet drugs that were pulled off the market in 1997.

According to Dr Roth, the drugs cause cells in the valves to multiply and thicken until the valves can no longer open and close properly. “The incidence is kind of mind-blowing,” he told the Wall Street Journal on January 4, 2007.

“It’s so prevalent in people taking these medications,” he said, “you kind of wonder why it was missed.”

Medical experts are not advising all patients who have taken these drugs to undergo testing to determine whether they have developed heart valve disease.

Filed under: 2007, FDA, Permax

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