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Mới Về Thuốc _ FDA _ F&C
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Leucoleucovorin: new Cancer
Drug Approved
3/12/2008
The FDA has approved Spectrum Pharmaceuticals™ Levoleucovorin for injection
for use after high-dose methotrexate therapy in patients with osteosarcoma,
and to diminish the toxicity and counteract the effects of impaired methotrexate
elimination or inadvertent overdose of folic acid antagonists. Marketing
of the drug should begin by June 2008. The company also plans to file
a SNDA for the drug™s use in colorectal cancer in 5-fluorouracil-containing
regimens and an NDA for an oral tablet formulation by the middle of 2008.
Updated Black Box Warnings Approved for
Erythropoiesis-Stimulating Agents (ESAs)
3/12/2008
The FDA has approved updated safety information, including expanded black
box warnings about the increased risk of death and tumor growth, for Aranesp
(darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)
based on new data from studies conducted in patients with breast, non-small
cell lung, head and neck, lymphoid, and cervical cancers. The updated
warning states that ESAs shortened overall survival and/or time-to-tumor
progression when dosed to target hemoglobin of greater than or equal to
12 g/dL. The FDA updated warnings for these drugs twice last year.
Safe Tussionex Pennkinetic Use
3/13/2008
The FDA has received reports of life-threatening adverse events, including
death, in patients who have received Tussionex Pennkinetic (hydrocodone
bitartrate/chlorpheniramine polistirex) extended-release suspension. The
reports indicate that health care professionals have sometimes prescribed
Tussionex for patients younger than the approved age group (6 years of
age and older) or more frequent dosing than the labeled interval of every
12 hours. In addition, patients have sometimes misinterpreted the dosing
directions and used inappropriate measuring devices for the suspension
resulting in incorrect doses. Prescribers should be familiar with Tussionex
dosing recommendations before prescribing, while patients and caregivers
should use a properly marked measuring device to prevent overdose.
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