FDA: New Options for Colorectal Cancer and Influenza, Warnings for Antibacterial Drug
Lonsurf – Colorectal Cancer
The FDA has approved Lonsurf (trifluridine/tipiracil) for the treatment of patients with advanced colorectal cancer no longer responding to other therapies.
The safety and efficacy of Lonsurf were tested in a randomized, double-blind study of 800 patients previously treated with chemotherapy or biological therapy for colorectal cancer. Overall, patients treated with the drug lived an average of 7.1 months compared with 5.3 months of those treated with placebo.
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The most common side effects of the drug include anemia, weakness, tiredness, nausea, diarrhea, and fever.
The FDA has recommended that healthcare professionals monitor patients throughout treatment with Lonsurf, as the drug may also cause a severe decrease in blood cell and platelet production.
Avycaz Dose Confusion
The FDA has relseased a warning about possible dosing errors with the antibacterial drug Avycaz (ceftazidime/avibactam) due to confusion about the strength of the drug. While the carton and labels list the strength of its individual active ingredients, the drug is dosed based on the sum of its active ingredients.
“To prevent medication errors, FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.”
The warning was based on 3 reports of medication error related to confusion over the strength of drug as it was displayed on the labels.
Cobas Influenza A/B test
The FDA has granted Clinical Laboratory Improvement Amendments (CLIA) waiver for the cobas Influenza A/B test, a real-time polymerase chain reaction (PCR) test to detect influenza A and B in around 20 minutes. The test can now be used in non-traditional testing sites, including physician offices, emergency rooms, and clinics.
“Effective management of influenza relies on accurate detection within 48 hours of onset, which can be challenging with current turnaround times for lab-based test results. The cobas Influenza A/B test provides lab-quality PCR results in ~20 minutes, enabling health care providers in all settings to give prompt and confident diagnosis and treatment to patients.”
—Michael Potts
References:
- FDA. FDA approves new oral medication to treat patients with advanced colorectal cancer [press release]. September 22, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463650.htm.
- FDA. Avycaz (ceftazidime and avibactam): drug safety communication - dose confusion and medication errors [press release]. September 22, 2015. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm463595.htm.
- Roche. Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System [press release]. September 22, 2015. http://www.roche.com/media/store/releases/med-cor-2015-09-22.htm.