Recalls, warnings, alerts and label changes
A recall of more than 60 Actavis generic drugs after an FDA inspection showed the company's operations didn't meet good manufacturing practices. The recall affects all products made at Actavis' Little Falls, N.J. facility, including oxycodone, glyburide, guanfacine and mirtazapine. A full list of recalled drugs is available online.
A Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles because it may result in injury or death. Levitronix recently issued a letter warning doctors not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because such use may result in stoppage of the pump and cause serious injury or death.
A recall of lots 856396A and 856693A of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL unit dose bottles, used to treat hyperkalemia. A sample from lot 856396A tested positive for a strain of yeast, which could cause infection in immunocompromised patients.
A revised boxed warning about risks associated with micro-bubble contrast agents Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection). Due to the risk of serious cardiopulmonary reactions during or within 30 minutes of administration of these products, patients with pulmonary hypertension or unstable cardiopulmonary conditions should be closely monitored during this time period.
A warning that the X-rays used during CT exams may cause some external electronic medical devices to malfunction, as has happened in a few cases with pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps.
A warning against combining bevacizumab (Avastin) with sunitinib malate. Several cases of microangiopathic hemolytic anemia (MAHA) have been reported in patients with solid tumors receiving this combination as part of a Phase I trial.
An alert to avoid prescribing more than 20 mg per day of simvastatin (Zocor, Vytorin, Simcor) if a patient is taking amiodarone (Cordarone, Pacerone), as the combination increases the risk of rhabdomyolysis, especially at simvastatin levels above 20 mg/daily.
A label change clarifying use of epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp) to treat anemia in patients undergoing chemotherapy. Treatment should only begin when a patient's hemoglobin level drops to 10 g/dL, and the drugs shouldn't be used when the expected outcome of chemotherapy is to cure a patient of cancer.
Intravenous clevidipine butyrate (Cleviprex) to reduce blood pressure. The dihydropyridine calcium channel blocker has a quick onset and offset of action that can be titrated for exact control in a critical care setting. The drug may produce systemic hypotension and reflex tachycardia; its most common adverse reactions are headache, nausea and vomiting.
The eSensor Warfarin Sensitivity Test to identify patients who may be sensitive to warfarin. The test detects the three genetic markers known to play a critical role in metabolism of warfarin, which in turn helps physicians decide on a dosage level.
The Pathwork Tissue of Origin, which helps determine the kind of cancer cells present in a malignant tumor. The test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database, and considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.