主页 > 医药生命 >
【drug-news】FDA要求贫血药标上更多警告提示
Anemia Drugs Carry More Warnings
Posted by Shirley S. Wang
Widen that warning label, the FDA said to makers of anemia drugs known as erythropoiesis-stimulating agents
Often used in patients with chronic kidney failure or undergoing chemotherapy, the pricey drugs have been dogged by safety questions, as the Health Blog has noted. The main debate concerns whether ESAs–namely, Amgen’s Aranesp and Epogen, and J&J’s Procrit–might be too much of a good thing. Can they cause more health problems than they solve when used too liberally?
In March, the FDA revised the warning labels on these drugs by asking doctors to monitor patients’ red blood cell levels and to use the lowest dose possible. Medicare declared this summer that it would limit paying for ESAs to patients with lower levels of red blood cells, a decision the FDA backed.
Now, the FDA is again asking companies to step up the warnings. The instructions will now say that ESAs cause “tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer.” Furthermore, the agency is requiring the drugs carry a statement that “symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who are treated with ESAs.”
For patients with chronic kidney failure, the new warning says ESAs should be used to maintain a hemoglobin, the protein that carries oxygen, to 10 grams per deciliter of blood and 12 g/dL, as had been expected.
Amgen, as a result, has had a busy news day. The company declared in a release that it has updated its packaging to comply with the FDA guidelines. It also publicized that it has proposed half a dozen new clinical trials to assess the safety of ESAs, and will file new data to the Centers for Medicare and Medicaid Services asking it to reconsider its position on capping coverage of ESA-treatment in cancer patients to those with hemoglobins below 10 g/dl. [标签:content1][标签:content2]
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-04-09 05:11
医学,生命科学网