Saturday, January 27, 2007

Beware: Permax (pergolide mesylate) 2003 Safety Letter

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.
Valerie E. Simmons, MD, FFPM
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.

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, you should contact Bagolie Friedman Injury Lawyers immediately for a free and confidential consultation.

Tuesday, January 23, 2007

Blood Thinner Medication Warfarin Linked To Brain Bleeds In Elderly

(Posted by Tom Lamb at

The January 9, 2007 edition of the medical journal Neurology has a report concerning a new study which reveals that elderly patients using the blood-thinning medicine warfarin may be at greater risk for having a serious brain hemorrhage. Warfarin is sold under various different brand names, with one of the more popular being Coumadin.

According to a January 9, 2007 Newsday article by staff writer Jamie Talan about this Neurology article regarding the new warfarin study:

Scientists at the University of Cincinnati College of Medicine found that use of the anticoagulant medicine increased in the 1990s, and the surge in prescriptions caused a rise in the number of drug-induced intracerebral hemorrhages, especially in people over age 80.

"We've had no idea how often this was happening," said Dr. Matthew Flaherty, lead author of the study that appears in the journal Neurology. Use of the blood thinner increased after many studies showed warfarin was effective at preventing ischemic strokes in people with atrial fibrillation, an abnormal heart rhythm.

As background, ischemic strokes are caused by a blood clot that forms in the brain or travels to the brain. By contrast, intracerebral hemorrhages involve a blood vessel bursting in the brain; as such, it is commonly referred to as a brain bleed. An intracerebral brain hemorrhage is a relatively rare form of stroke, accounting for less than ten percent of total annual stroke events.

The practical effect of this news about the increased risk of brain bleeds in elderly patients using warfarin, or Coumadin, was covered in a January 8, 2007 article by HealthDay reporter Steven Reinberg:

One expert thinks that doctors need to evaluate a patient's risk of stroke versus their risk of bleeding before prescribing warfarin.

"This study demonstrates that we need to be careful when we use these therapies," said Dr. Michael B. Rothberg, an associate professor of medicine at Tufts University School of Medicine.

Not all patients with atrial fibrillation will benefit from warfarin, Rothberg added. "Not all patients with atrial fibrillation should be getting warfarin," he said. "Patients at the highest risk for stroke will benefit the most, and patients at the highest risk for bleeding will benefit the least," he said.

Rothberg noted that although warfarin is standard treatment for atrial fibrillation, not everyone with atrial fibrillation is at the same risk of stroke. "I don't think that most doctors prescribing warfarin are assessing their patient's risk of stroke and risk of bleeding, but they should be," he said.

In closing, we want to make an important point: As with all prescription medications, patients should talk to their doctors before making any decisions not to take warfarin, or Coumadin.

Saturday, January 13, 2007

Bagolie Quoted in Herald News Medical Malpractice Article

Bagolie Friedman Injury Lawyers founding partner Ricky Bagolie was recently interviewed by Betsy Querna of The Herald News for an article entiltled
When Medical Care Makes Things Worse.

Legal remedy

Many turn to the legal system for recourse, though it is often in vain. "If you see 100 cases, 99 turn out not to be something actionable or worth filing," says Ricky Bagolie, a malpractice lawyer who grew up in Clifton. "A bad result doesn't mean it was negligent or bad care."

Buchalla contacted a lawyer about filing a lawsuit for allegedly bad care. He was told nothing could be done because there was no proof of wrongdoing.

Santos Sanchez, 52, of Passaic, says he contacted several lawyers, but none would take his case. He was unhappy with a breast-reduction surgery earlier this year.

If you or a loved one has been hurt or has been a victim of medical mistake or malpractice, contact Bagolie Friedman Injury Lawyers now for a confidential and free consultation.