Schmidt & Clark, LLP, a mass torts law firm has reported receiving a significant number of inquiries from Reglan users claiming to suffer from serious side effects including a movement disorder known as Tardive Dyskineisa.

Approved in 1995, Reglan (Generic: metoclopramide) is a prescription medication that is designed to treat primarily gastro intestinal disorders, particularly, when there is a motility issue with the stomach or intestines. Reglan is indicated for short-term use although, a physician may sometimes determine to prescribe Reglan for a longer period of time and for other medical conditions.

Safety experts from the Duke University School of Medicine, publishing in the November/December 2004 Journal of the American Pharmacists Association, caution that the use of Reglan is increasing and that this fact may result in more cases of drug-induced movement disorders from the medication.

The U.S. Food & Drug Administration (FDA) has ONLY approved Reglan for short-term use (4 to 12 weeks) and ONLY when conservative treatment fails.

Long-term use of Reglan may cause a serious side effect known as Tardive Dyskinesia (TD). TD may be accompanied by very mild symptoms to a more severe form which causes a life-long and irreversible neurological movement disorders.

TD is characterized by repetitive, involuntary and purposeless movements. Signs of the disorder may include the following symptoms:

Involuntary jerking movements/spasms of the tongue, face, mouth and jaw.

• Uncontrolled facial grimacing
• Tongue protrusion
• Lip smacking
• Lip puckering/pursing
• Rapid eye blinking
• Uncontrollable movement in the arms, legs, and trunk
• Involuntary movement on the hands and fingers 

If you believe that you may have developed TD as a result of taking Reglan, it is important that you contact your physician and be evaluated.

Michael Schmidt, Managing Partner of Schmidt & Clark has noticed an alarming number of inquiries to the firm related to Reglan. Mr. Schmidt stated “We are a firm that focuses on mass torts litigation. As a result, we have received a large number of inquiries where the party has stated that they have been diagnosed with Tardive Dyskinesia after having taken Reglan. While there have been warnings regarding TD by the manufacturer, based on the number of calls to my office and the study cited by the Duke University School of Medicine and the Journal of the American Pharmacists Association, it would appear that the number of Reglan related TD cases and inquiries to my office may continue to rise.”

About Schmidt & Clark, LLP

Schmidt & Clark is a national law firm that focuses on mass torts, personal injury, product liability, environmental litigation, toxic exposure, transportation disasters, automotive crashworthiness, medical device failures and medical malpractice.

Schmidt & Clark is currently evaluating potential Reglan lawsuits in all states whereby the patient has 1) been diagnosed by a physician with TD and 2) has been on Reglan at the time of the diagnosis. For more information on Schmidt & Clark, LLP, please visit: www.schmidtandclark.com or call toll free 24 hrs/day (866) 588-0600.

Reglan patients can learn more about Reglan and Tardive Dyskinesia by visiting: http://www.schmidtandclark.com/Reglan

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CONTACT INFORMATION

Michael Schmidt
Schmidt & Clark, L.L.P.
schmidt@schmidtandclark.com
(866) 588-0600

Source | Prime Therapeutics LLC  

A recent Prime Therapeutics (Prime) study found significant patterns of “off-label” prescribing for Actiq(R) among patients taking the powerful painkilling “lollipop.” Prescribing Actiq according to FDA guidelines is important for patient safety reasons because of the drug’s serious side effects, including its addictive nature.

The results of the Prime study confirm concerns about the drug, which have been highlighted recently by the national news media. Prime, a thought leader in pharmacy benefit management, provides programs that manage the use of Actiq and other dangerous drugs in an effort to promote health and safety while ensuring that patients get the treatment they need.

“The FDA has only approved Actiq for use by cancer patients who are already taking a long-acting, chronic painkiller but suffer from severe spikes in pain,” stated Pat Gleason, PharmD, Director of Medical and Pharmacy Integration Services for Prime. “The Prime study, however, found that only slightly more than 10 percent of the patients receiving the drug over a three- month period in 2005 met those guidelines. Nearly 90 percent of Actiq prescriptions in our study were off-label, or not prescribed according to the guidelines set forth by the FDA.”

Actiq contains fentanyl, a known potent synthetic opioid with a high potential for abuse and overdose. In addition, fentanyl has been linked to fatal respiratory complications. As a result, while physicians are allowed to prescribe medications for unapproved or “off-label” use, the FDA recommends strict adherence to Actiq’s prescribing guidelines.

Last year, in response to the safety concerns highlighted in the study, Prime began offering programs to promote Actiq’s safe use. These programs include a monthly limit of 120-doses of Actiq, or a newer related drug, Fentora(R). Patients are also required to have prior authorization from their doctor and prescriptions are limited to a 12-month period. Prime’s program also encourages members to take a long-acting opioid for chronic pain. The program guidelines follow FDA recommendations.

“There are serious safety issues regarding Actiq, so doctors need to be careful how it is prescribed,” said Gleason. “Prime integrates pharmacy and medical data to identify misuse of drugs such as Actiq and then develops programs to ensure patient safety. Our drug utilization programs not only keep members safe, but save health plans thousands of dollars a month.”

The study analyzed Actiq patient claims from a Midwestern commercial health plan from April through June 2005. Of the 95 patients who received prescriptions for the lollipop during that time, only 21 had a diagnosis of cancer or AIDS. In addition, only 10 of those 21 patients were taking a long- acting opioid painkiller. Overall, 84 of the 95 Actiq prescriptions, nearly 90 percent, were for off-label purposes. The study also found that more than 15 percent of Actiq prescriptions were for more than the FDA’s recommended 120 lollipops per month, suggesting that some patients may be overusing the drug.

Source | U.S. Food & Drug Administration

Advanced Medical Optics Announces Voluntary Recall of 18 Lots of Complete(R) MoisturePLUS(TM) Contact Lens Care Products Distributed and Sold in the U.S. Includes Certain Lots of 12-Ounce Bottles and Active Packs

FOR IMMEDIATE RELEASE — Santa Ana, CA — November 21, 2006 — Advanced Medical Optics, Inc., a global ophthalmic surgical and eye care products company, today announced a nationwide, voluntary recall of certain lots of its 12-ounce COMPLETE MoisturePLUS(TM) multipurpose contact lens care solution and Active Packs. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at its manufacturing plant in China, AMO is recalling 18 lots distributed in the U.S. that were manufactured on the same production lines during the same production period. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis. AMO has not received any reports of adverse health events associated with the recalled product lots in the U.S.

Lot numbers are located on the top of the product box and on the side of the product bottle. The recalled product lots include:

Contact lens users who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.

What You Can Do & How We Can Help

If you or a loved one have used Complete MoisturePLUS and developed a serious side effect like microbial keratitis or corneal infection, you should contact us immediately. You may be entitled to compensation and we can help.

Source | The New York Times

By DENISE GRADY

Two drugs used to treat Parkinson’s disease and other disorders can seriously damage heart valves, researchers are reporting.

The drugs are pergolide, sold as Permax, and cabergoline, sold as Dostinex. Permax is approved in the United States and overseas for Parkinson’s. Dostinex is used for Parkinson’s in other countries but is approved in this country only for a hormonal disorder, hyperprolactinemia.

New findings on the drugs are described in two studies being published today in The New England Journal of Medicine.

Permax already carries a black-box warning label — the strongest warning required by the Food and Drug Administration — about an increased risk of heart-valve problems. Such warnings, bordered in black, appear at the top of prescribing information to get doctors’ attention. The Permax warning was added in 2003, based on a small number of reported cases. It includes this statement: ‘’Some patients have required valve replacement, and deaths have been reported.'’

A milder warning about valve problems was added to Dostinex just last month. It is identified as a ‘’precaution,'’ which means there is no black box, and the advice is in a less obvious part of the prescribing information for doctors.

A spokeswoman for the drug agency said that it had worked with the makers of both drugs on the labeling changes, but that she did not know whether the new findings would lead to further changes.

Dr. Michael S. Okun, the medical director for the National Parkinson Foundation, said people taking Permax or Dostinex for Parkinson’s should be told about the new information and given a chance to switch to other drugs. He added that patients who were just starting treatment should be given other drugs. Safer, equally effective drugs are available, he said.

Dr. Okun, who was not involved in the two studies, is also co-director of the Parkinson Disease and movement disorders center at the University of Florida in Gainesville.

He said doctors in poorer countries might favor Permax and Dostinex because they are cheaper than some other Parkinson’s drugs. But Dr. Okun said it would cost no more to switch patients to the old Parkinson’s standby drug, L-dopa or levodopa, which has side effects of its own, but has never been known to damage heart valves.

‘’Patients should be given the choice of what to do,'’ Dr. Okun said. ‘’There are lots of people worldwide who have used these drugs successfully. Some patients, after being educated, may decide they want to accept the potential risk. Others may want to switch.'’

Another researcher took a far different view.

‘’I would just recommend not prescribing these drugs,'’ said that researcher, Dr. Bryan L. Roth, who wrote an analysis of the research that accompanied the articles in The Journal. Dr. Roth is a professor of pharmacology and medicinal chemistry at the University of North Carolina School of Medicine and director of the psychoactive drug screening program at the National Institute of Mental Health.

Dr. Roth called the risk of valve disease ‘’extraordinarily high'’ and asked: ‘’Why would you want to subject your patient to this kind of risk? I wouldn’t.'’

Valeant Pharmaceuticals, which makes Permax, issued a statement by e-mail calling the drug safe and effective for Parkinson’s. But Valeant added that it no longer promoted the drug, which was originally made by Eli Lilly.

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.

The hormone disorder affects tens of thousands of people in the United States, mostly women, said Dr. Shlomo Melmed, an endocrinologist and a senior vice president of Cedars-Sinai Medical Center in Los Angeles. Men can develop the disorder, and some need higher doses of Dostinex than do women, Dr. Melmed said, so those men should be monitored for heart valve problems.

Correction: January 19, 2007, Friday An article on Jan. 4 about heart-valve problems linked to two drugs for Parkinson’s disease misstated the year that one of them, Permax, added a black-box warning label, the strongest warning required by the Food and Drug Administration. It was 2006, not 2003.

Neither drug is a big seller. About 73,000 prescriptions were written for Permax last year, representing $10.5 million in the billion-dollar market for Parkinson’s drugs in the United States, according to IMS Health, which tracks drug sales.

About 1.5 million Americans have Parkinson’s, according to the National Parkinson Foundation. 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.

The two new studies are larger than previous ones, and they confirm the higher risk of valve damage in people taking either drug for Parkinson’s. The studies also find that the valve problem is more common than initially thought, and that people who took the highest doses for the longest time had the greatest risk.

One study, from the Istituti Clinici di Perfezionamento in Milan, included 155 patients with Parkinson’s and found that 23 percent of those taking Permax and 29 percent of those taking Dostinex had damaged heart valves, compared with only almost 6 percent of control subjects not taking the drugs.

The other study, based on the records of more than 11,000 patients with Parkinson’s in Britain, found that valve problems were seven times as likely in people taking Permax as in control subjects and five times as likely in those taking Dostinex.

Dr. Roth said the drugs produced the same kind of valve damage caused by the weight loss combination fen-phen, which led to the withdrawal of two drugs, Pondimin and Redux, in 1997. The drugs cause cells to multiply in the heart valves, which causes the valves to thicken so much that they can no longer open and close normally.

Correction: January 19, 2007, Friday An article on Jan. 4 about heart-valve problems linked to two drugs for Parkinson’s disease misstated the year that one of them, Permax, added a black-box warning label, the strongest warning required by the Food and Drug Administration. It was 2006, not 2003.

Correction: January 19, 2007, Friday An article on Jan. 4 about heart-valve problems linked to two drugs for Parkinson’s disease misstated the year that one of them, Permax, added a black-box warning label, the strongest warning required by the Food and Drug Administration. It was 2006, not 2003.

Do I Have a Permax or Dostinex Lawsuit?

If you or a loved one have taken Permax or Dostinex and suffered from any of the side effects listed below, you should contact us immediately. You may be entitled to compensation and we can help.

Source | Associated Press

By MARILYNN MARCHIONE

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.

Do I Have a Permax or Dostinex Lawsuit?

If you or a loved one have taken Permax or Dostinex and suffered from any of the side effects listed below, you should contact us immediately. You may be entitled to compensation and we can help.

Source | The New England Journal of Medicine

Two “dopamine agonist” drugs commonly used to treat Parkinson’s disease — pergolide (Permax; Eli Lily) and cabergoline (Dostinex; Pfizer) — may raise the risk of heart valve regurgitation, according to the findings of two European studies appearing in The New England Journal of Medicine this week.

The new findings support what has been seen in earlier studies.

In the first study, Dr. Rene Schade, from Charite-Universitatsmedizin Berlin, and colleagues assessed dopamine agonist use among 31 patients who were prescribed a drug for Parkinson’s disease and were later diagnosed with cardiac valve regurgitation, in which the valve fails to seal properly in the reverse-flow direction. Each case patient was matched to up to 25 “control” subjects by age and sex.

The case patients included six taking Permax, six on Dostinex and 19 who had not taken any dopamine agonist in the last year.

The investigators found that current use of Permax or Dostinex raised the risk of valve regurgitation by 7.1- and 4.9-fold, respectively. Taking other dopamine agonists seemed to have no effect on the risk of cardiac valve regurgitation.

In the second study, Dr. Renzo Zanettini, from the Istituti Clinici di Perfezionamento in Milan, and colleagues assessed valve regurgitation in 64 Permax users, 49 Dostinex users, 42 users of other dopamine agonists, and 90 control subjects.

Regurgitation was noted in roughly 23 percent of Permax users, 29 percent of Dostinex users, none of the users of other dopamine agonists, and 6 percent of controls. The severity of regurgitation with Permax and Dostinex seemed to increase with the dosage of the drugs.

In a related commentary, Dr. Bryan L. Roth, from the University of North Carolina at Chapel Hill, notes that in addition to stimulating dopamine receptors, both Permax and Dostinex stimulate serotonin receptors, a key step in the progression of drug-induced valve disease.

Roth advises doctors to avoid prescribing drugs that are potent serotonin receptor agonists such as Permax and Dostinex.

Do I Have a Permax or Dostinex Lawsuit?

If you or a loved one have taken Permax or Dostinex and suffered from any of the side effects listed below, you should contact us immediately. You may be entitled to compensation and we can help.

Source | FDA 

Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
Dear Health Care Professional,

During postmarketing surveillance for Permax®, a small number of individuals have been identified as developing cardiac valvulopathy involving one or more valves during Permax therapy. Based on Lilly safety data and scientific publications, the pathological assessment of valves that were surgically removed was consistent with the valvulopathy associated with carcinoid syndrome and with the use of other ergot alkaloid drugs. While a clear causal relationship between pergolide and the valvulopathy seen in these patients can not be established, given the nature of the lesions and known similar effects of other ergots, the Warnings section of the US Package Insert for Permax will be modified to reflect these reports.

In the reports made to Lilly, aortic, mitral and tricuspid valves were involved. In some cases the symptoms or manifestations of valvulopathy improved with cessation of pergolide therapy. Valve replacement was required in two patients.

It is not known whether the fibrotic valvular changes are related to retroperitoneal, pleural, and pericardial fibrosis, which are very rare but well known adverse effects seen with Permax.

Since Permax was first launched in the United States in 1989, a very limited number of cases have been reported to Lilly and to the FDA. Of the estimated 500,000 people who have been treated with pergolide since 1989, valvulopathy has been reported in less than 0.005%.

Based on these reports, the Warnings section of the US Package Insert for Permax will be modified as follows (new wording underlined):

Serous Inflammation and Fibrosis–There have been rare reports of pleuritis, pleural effusion, pleural fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves, or retroperitoneal fibrosis in patients taking pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide. Pergolide should be used with caution in patients with a history of these conditions, particularly those patients who experienced the events while taking ergot derivatives. Patients with a history of such events should be carefully monitored clinically and with appropriate radiographic and laboratory studies while taking pergolide.

If you have additional questions regarding Permax, you may contact Amarin Pharmaceuticals, Inc., our US licensee for Permax, at 1-800-969-4877.

Sincerely,

Valerie E. Simmons, MD, FFPM
Director
Worldwide Pharmacovigilance and Epidemiology
Eli Lilly and Company

Permax® is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson’s disease. Please see accompanying Prescribing Information. Permax is a registered trademark of Eli Lilly and Company, and is licensed exclusively in the United States to Amarin Pharmaceuticals, Inc.

FOR IMMEDIATE RELEASE — Los Angeles, CA — January 19, 2007 — Ebek, Inc., 3921 Wilshire Boulevard, Suite 307, Los Angeles, Ca 90010, announced today that it is conducting a voluntary nationwide recall of the Company’s supplement product sold under the name Liviro3. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Liviro3 samples found the product contains tadalafil, an FDA-approved drug used to treat erectile dysfunction (ED), making Liviro3 an unapproved drug. FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing.

The recalled Liviro3 is sold in 10-tablet boxes or 20-tablet plastic bottles. The product label warns consumers with high blood pressure not to ingest the product but does not state it contains tadalafil.

Consumers who have Liviro3 in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. The public is encouraged to submit a report of any serious adverse events that occur with the use of Liviro3 to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm ], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Ebek has taken this voluntary action because it is committed to providing accurate information about its products and because of concern for the health and safety of consumers. Ebek is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

No illnesses have been reported to the Company to date in connection with this product.

Consumers should return any unused Liviro3, for a refund of the full purchase price or price for the unused portion, to the retail location where it was purchased or to Ebek directly at (213) 480-0316 or by email at recall@liviro.com to receive further instructions for returning the product or with any questions.

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FDA’s Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html 

On June 23, 2006 Guidant Corporation in association with the U.S. Food & Drug Administration (FDA) issued a recall of a large number of VITALITY® 2 defibrillators.

Guidant Corporation Comments: a limited number of these devices contain a part (component) that on rare occasion may prevent the device from delivering therapy, or cause the device’s battery to run down before it should.

Do I Have a Guidant VITALITY® 2 Recall Lawsuit?

If you or a loved one have a Guidant VITALITY® 2 defibrillator, regardless of whether or not you have experienced device malfunctions or failure, you should contact us immediately. You may be entitled to compensation and we can help.

Get Legal Help Now >>> Guidant VITALITY® 2 Recall Lawsuit

On June 23, 2006 Guidant Corporation in association with the U.S. Food & Drug Administration (FDA) issued a recall of a large number of VITALITY® defibrillators.

Guidant Corporation Comments: a limited number of these devices contain a part (component) that on rare occasion may prevent the device from delivering therapy, or cause the device’s battery to run down before it should.

Do I Have a Guidant VITALITY® Recall Lawsuit?

If you or a loved one have a Guidant VITALITY® defibrillator, regardless of whether or not you have experienced device malfunctions or failure, you should contact us immediately. You may be entitled to compensation and we can help.

Get Legal Help Now >>> Guidant VITALITY® Recall Lawsuit