Anemia drugs sold by Amgen and Johnson & Johnson have been reported to cause strokes when prescribed in high doses, according to an article from the FDA, recently published in the The New England Journal of Medicine. The law firm of Aylstock, Witkin, Kreis & Overholtz is investigating the FDA’s recent announcement.
The FDA commentary said the latest study and previous studies “raise major concerns” about the use of these drugs to treat anemia caused by kidney disease. The drugs are also used to treat anemia caused by chemotherapy. Studies over the past several years have revealed a link between the drugs and heart attacks, strokes, and other problems.
Amgen’s anemia drugs include Epogen and Aranesp. Johnson & Johnson sells anemia drug Procrit, which is produced by Amgen. The drugs are designed to raise red blood cell levels, to promote delivery of oxygen to body tissues.
According to the FDA, results from the most recent clinical trial that showed people taking one of the drugs suffered twice as many strokes as those on placebo (a substance with no effects that a doctor gives to study participants instead of a drug, for comparison with those on the drug). Study participants also showed no significant benefits from taking the drug. Those taking the drugs had just as many deaths and cardiovascular problems as those taking placebo in the study.
FDA officials said they will ask an outside advisory committee to re-evaluate use of the Amgen and Johnson & Johnson anemia drugs.
Since 2007, the FDA 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.
Sales of one of the drugs, Aranesp, reached $4.1 billion in 2006, but are expected to decline to below $3 billion following the study results discussed in the FDA commentary. Use of the Johnson & Johnson and Amgen anemia drugs has been falling since 2007, when studies showed that the drugs might cause heart attacks and strokes and might worsen the condition of cancer patients.
The most recent study cited in the FDA commentary was a study called “Treat,” published Oct. 30 in The New England Journal of Medicine. The trial showed the drugs failed to help people. Trial results also shows that those taking Aranesp suffered twice as many strokes as those taking only placebo.
Doctors outside the FDA are also advising caution in use of the drugs. Dr. Ajay K. Singh of Brigham & Women’s Hospital and Harvard Medical School said because of “the remarkable observations from the Treat study,” doctors should avoid use of the drugs in any patients except those undergoing dialysis.
A Medicare advisory panel is scheduled to meet in March to discuss coverage of use of these anemia drugs. Medicare is already changing coverage to encourage less use of such drugs, according to agency officials.
If you have any information relating to injuries sustained by a consumer as described herein, please contact the litigation team of Aylstock, Witkin, Kreis & Overholtz for an immediate, free consultation regarding your legal rights – toll free at: 877-810-4808.
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