Pharmaceutical Drug Litigation Updates

Anemia Drugs Hold Dangers for Kidney Patients

Quoted from http://health.usnews.com/health-news/family-health/digestive-disorders/articles/2010/05/05/anemia-drugs-hold-dangers-for-kidney-patients.html

Anemia Drugs Hold Dangers for Kidney Patients

Study finds increased risks for potential deadly complications

By Ed Edelson
HealthDay Reporter

WEDNESDAY, May 5 (HealthDay News) -- The powerful drugs used to fight anemia caused by kidney failure increase the risk for cardiovascular problems such as heart attack, a major study has found.

A meta-analysis of 27 trials, which included more than 10,000 people who were given the drugs, known as erythropoiesis-stimulating agents (ESAs), found that those who took the drugs at the highest dosages had a 51 percent increased risk for stroke and a 33 percent increased risk for thrombosis, or blockage of an artery. The study, by an international group of experts, was published online May 3 in Annals of Internal Medicine.

The increased risk for death (9 percent) and serious cardiovascular events such as heart attacks (15 percent) did not reach statistical significance, the analysis found.

The U.S. Food and Drug Administration has acted to control the use of ESAs marketed as Epogen, Procrit and Aranesp, which stimulate production of red blood cells to treat the anemia caused by kidney failure and cancer chemotherapy. The agency has added a "black box" warning of dangers to ESA labeling.

The new study adds emphasis to such moves, said Dr. Ajay K. Singh, an associate professor of medicine at Harvard Medical School and a nephrologist at Brigham and Women's Hospital in Boston.

"This meta-analysis shows increased risk with no benefit," Singh said. "The supposed benefit is that ESAs improve quality of life and make people feel better. This study suggests that these drugs, used at considerable cost, don't show any benefit in terms of those endpoints."

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US Medicare panel eyes ESA use in kidney patients

Quoted from http://www.reuters.com/article/idCNN1715734820100319

US Medicare panel eyes ESA use in kidney patients

Fri Mar 19, 2010 6:41pm EDT

By Susan Heavey

WASHINGTON, March 19 (Reuters) - Closer government scrutiny of controversial anemia drugs made by Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N) is likely to reopen debate on how much the drugs should be used and could further depress sales.

Next week, the Centers for Medicare & Medicaid Services (CMS) plans to seek advice from a panel of outside experts over use of the blockbuster drugs in patients with chronic kidney disease, given concerns over possible heart dangers.

The drugs, known as erythropoiesis-stimulating agents (ESAs), have already weathered recent warnings and restrictions over their use in cancer patients that have caused doctors to lower doses and sales to slump.

On Wednesday, the agency will ask its panelists how confident they are that current data supports use of the drugs -- Johnson & Johnson's Procrit and Amgen's Aranesp and Epogen -- in a smaller group of patients with all stages of kidney disease.

CMS, which insures more than 45 million elderly, disabled and poor Americans, currently has no formal reimbursement policy for such use, leaving it to vary region by region.

Analyst Joshua Schimmer, managing director of biotechnology research at Leerink Swann, said CMS is ultimately likely to push for less use of the drugs nationwide.

"It's probably going to clip sales to some extent," said Schimmer, who estimates sales could dip 15 percent to 20 percent. "At the end of the day, we're all expecting it."

ESAs have come under scrutiny in recent years after studies emerged showing high doses could lead to heart complications or even death. While dosing has been affected, the costly drugs are still widely used.

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FDA unveils risk-management plan for Amgen anti-anemia drugs

Quoted from http://www.latimes.com/business/la-fi-fda-amgen17-2010feb17,0,6272971.story

FDA unveils risk-management plan for Amgen anti-anemia drugs

Studies have shown that the drugs, which sell under the trade names Epogen, Aranesp and Procrit, can cause tumors to grow faster and shorten the lives of some cancer patients.

By Andrew Zajac

February 17, 2010

Reporting from Washington - Physicians who want to prescribe Amgen Inc.'s anti-anemia drugs for cancer patients will have to register and undergo special training under a risk-management plan unveiled Tuesday by the Food and Drug Administration.

Amgen also will require physicians to collect signed statements from patients attesting that they have been informed about the dangers of the drugs.

Studies have shown that the drugs can cause tumors to grow faster and shorten the lives of some cancer patients. They may also increase risk of heart failure, blood clots and stroke.

The risk-management plan had been under discussion since April 2008.

The drugs, which sell under the trade names Epogen, Aranesp and Procrit, are widely used by dialysis patients, but the safety plan applies only to use with cancer patients.

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F.D.A. to Review Safety of Anemia Drugs From Amgen and Johnson and Johnson

Quoted from http://www.nytimes.com/2010/01/07/business/07fda.html

F.D.A. Plans Safety Check of 3 Drugs for Anemia

• By ANDREW POLLACK
• Published: January 6, 2010

The Food and Drug Administration said Wednesday that it would review of the safety of the widely used anemia drugs sold by Amgen and Johnson & Johnson after another clinical trial suggested that high doses of one of the drugs might cause strokes.

In a commentary published online Wednesday by The New England Journal of Medicine, agency officials wrote that the results of the new trial, as well as of previous trials, “raise major concerns” about the use of the drugs to treat the anemia caused by chronic kidney disease.

The officials said the agency would convene an outside advisory committee to re-evaluate the use of the drugs in patients with kidney disease and to consider new ways to control doses of the products.

Amgen, a large biotechnology company, was built on the sales of its anemia drugs, Epogen and Aranesp. Johnson & Johnson sells Procrit, which is manufactured by Amgen. The drugs raise the body’s level of red blood cells, which ferry oxygen to the body’s tissues.

But sales have been falling since 2007, when studies renewed concerns that the drugs might cause heart attacks and strokes and also might worsen the condition of patients with cancer. The drugs are also used to treat the anemia caused by chemotherapy.

Since 2007, the F.D.A. has held three advisory panel meetings on these drugs and has changed the labels of the drugs to warn of risks and lower the doses used.

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Study confirms clot risks with anti-anemia drugs

Quoted from http://www.reuters.com/article/marketsNews/idCNN1032780720091110

Study confirms clot risks with anti-anemia drugs

 

By Julie Steenhuysen

CHICAGO, Nov 10 (Reuters) - Cancer patients who took drugs to cut the risk of anemia were twice as likely to develop blood clots in the lungs or legs as other patients, a decade-long study of more than 55,000 cancer patients has found.

The study adds to mounting evidence that the risks of the commonly used drugs -- known as erythropoiesis-stimulating agents or ESAs -- may outweigh the benefits.

ESAs stimulate bone marrow to increase the production of red blood cells. They were first approved in cancer patients in 1991 to reduce the number of blood transfusions needed during chemotherapy.

But despite widespread use of the drugs -- rising tenfold between 1991 and 2002 to nearly half of all cancer patients undergoing chemotherapy -- blood transfusion rates among these patients remained steady, Dr. Dawn Hershman of New York-Presbyterian Hospital/Columbia University Medical Center and colleagues reported on Tuesday in the Journal of the National Cancer Institute.

"We dramatically increased the number of patients that received these agents," Hershman said in a telephone interview. "In the entire time, the transfusion rate didn't change."

Sales of the drugs, including Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit, have fallen sharply since a late 2006 study by J&J showed a higher risk of death and cardiovascular complications for aggressively treated patients.

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