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【drug-news】新数据引起人们对贫血药安全的担心
A meta-analysis of late-stage studies reiterated safety concerns about drugs for patients with anemia related to cancer, such as Amgen's(AMGN - Cramer's Take - Stockpickr) Aranesp and Epogen, and Johnson & Johnson's(JNJ - Cramer's Take - Stockpickr) Procrit, ahead of a mid-March panel assessing the drugs' safety.
The study released by the Journal of the American Medicine Association Tuesday -- an update of a presentation Charles Bennett made to the American Society of Clinical Oncology in June 2007 -- is an analysis of phase III trial data related to erythropoiesis-stimulating agents, or drugs used for chemotherapy-induced anemia, from 1985 through Jan. 17 of this year.
Bennett found in an evaluation of 51 phase III trials involving 13,611 patients that the risk of death was significantly higher for patients with cancer who were treated with ESA vs. the control group. And in 38 trials involving a total of 8,172 patients, researchers found a significantly increased risk of blood clots.
The results translated to an estimated 57% increased risk of blood clot and a 10% increased mortality risk when ESAs were administered to patients with anemia and cancer, according to the study.
"These risks are important given the prevalence of ESA use as a supportive care drug among patients with cancer as well as the dissemination of a series of safety advisories by the FDA and ESA manufacturers," wrote the authors of the study.
The latest analysis land atop a growing mass of safety data and warnings for the drugs. The FDA cautioned in early January that the so-called Prepare breast cancer study, as well as a study in cervical cancer by the National Cancer Institute Gynecologic Oncology Group, showed greater death rates and tumor progression in patients who received ESAs.
Labeling and reimbursement changes and safety concerns for ESAs clipped sales Amgen's sales in 2007, wreaked havoc on its stock, and spurred a restructuring within the company. In the last quarter, worldwide sales of Aranesp were 25% lower than the year prior.
The FDA said in January that it's reviewing all of the new information on the ESAs and will take additional actions as appropriate. An upcoming advisory panel will re-evaluate the risk-and-benefit balance of the drugs.
"In the interim, healthcare professionals should consider the risks of tumor progression and decreased survival observed when ESAs are used as supportive care in patients with cancer," the agency recently noted.
Johnson & Johnson shares fell 63 cents, or 1%, to $63.09 in late trading. Amgen's stock backtracked 42 cents, or 0.9%, to $47.40, after rising 2.3% during the regular session.
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作者:admin@医学,生命科学 2011-04-27 05:14
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