FDA Reviews Anemia Drugs And Risk For Stroke
The Food and Drug Administration has announced that it will review whether or not anemia drugs increases a risk for stroke. This will not be the first time that the FDA reviews the risks of anemia drugs. The New York Times reports that an online commentary by the New England Journal of Medicine wrote that clinical trials suggest that high doses of anemia drugs may increase the risk for stroke related injury if the patients taking the drugs had diabetes or chronic kidney problems. It can also lead to a higher risk of cardiovascular events such as heart attacks.
ABC News reports that the FDA plans to use a panel of outside experts in order to investigate the safety of anemia drugs such as Aranesp, Epogen and Johnson & Johnson's Procrit. The drugs are often prescribed for anemic patients with chronic kidney disease and cancer patients who are undergoing chemotherapy. The drugs have been very profitable in the past, but this recent turn of events have hit the drug companies hard. Aranesp sales fell from $4.1 billion to just below $3 billion in the past three years. The New York Times said that Amgen, the maker of Aranesp, released a statement that said the medical journal "highlighted areas of incomplete understanding."
According to NPR, trials of close to 7,000 patients have shown a documented risk of cardiovascular events. The FDA wants to review the drugs because drug companies have not pinpointed optimal hemoglobin target levels or what the safest ways to reach those goals are. The FDA has held three panels since 2007, which discussed the labelling of risks on these drugs, as well as discerning whether or not to lower dosage amounts for patients.
Related Resources:
- Pharmaceutical Drug Liability (Findlaw)
- FDA Examines Anemia Drug Risks (Findlaw's Common Law)
- Study: Anemia Drugs May Pose Death Risk (Findlaw's Common Law)
- FDA Orders Labeling Changes for Anemia Drugs (Findlaw's Common Law)
- FDA Panel: Limit Anemia Drug Prescriptions (Findlaw's Common Law)
- Pharmaceutical Litigation (provided by Abraham Watkins Nichols Sorrels Agosto & Friend)
- Personal Injury FAQs (provided by Morrow Alexander Porter & Whitley PLLC)