FDA review: new blood tests and blood-loss products
By Jessica Berthold
An FDA advisory meeting will meet November 5 to talk about issues related to potential regulation of interventional mammography.
A joint meeting of two FDA panels recommended aprotinin (Trasylol), used to reduce blood loss in some patients during coronary artery bypass graft surgery, stay on the market. Studies suggest the drug may increase risk of death, kidney damage, congestive heart failure and stroke. The panel also voted against resetting allowable hemoglobin levels for use of darbepoetin alfa (Aranesp) and epoetin alfa (Epogen, Procrit) to treat anemia in kidney failure patients. Studies indicate the drugs may reduce survival and promote tumor progression in some patients.
Alerts, warnings and recalls
A safety alert on Fentanyl buccal (Fentora) warns that the drug should only be used to manage breakthrough pain in patients with cancer who are already receiving, and are tolerant to, opioid therapy for persistent cancer pain. Patients have died from improper use.
A recall is in effect for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005 and with serial numbers 205787 through 207509. The devices may display an error message that makes them inoperable.
At least 28 patients have had QT prolongation and torsades de pointes (TdP), and some have died, due to off-label use of intravenous haloperidol (Haldol). Injectable haloperidol is only approved for intramuscular injection.
A recall is in effect for B. Braun Medical Inc.'s Normal Saline Flush syringes with lot numbers ending in "SFR" due to an increase in particulate matter in the saline, which can damage vital organs and cause phlebitis.
Ceftriaxone (Rocephin) and calcium-containing solutions or products shouldn't be mixed, even via infusion lines at different sites. The two also shouldn't be administered within 48 hours of each other. Neonate deaths have been reported.
Pregnant women shouldn't start regimens containing nelfinavir mesylate (Viracept), and those currently receiving it should be switched to an alternative antiretroviral therapy if possible, due to a process-related impurity (ethyl methanesulfonate) that may be carcinogenic.
The Platelet Pan Genera Detection (PGD) Test System, the first rapid test to screen platelets for bacteremia before transfusion.
Fifteen new donor blood typing tests, previously unavailable in the U.S. The ALBAclone Blood Grouping Reagents are monoclonal antibodies and include the ABO and Rh tests, plus tests for rare blood types.
The Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test to help assess whether patients may be sensitive to warfarin (Coumadin). The test detects some variants of the genes CYP2C9 and VKORC1, which studies have linked to a greater risk of bleeding from warfarin.
Raloxifene hydrochloride (Evista) for reducing the risk of invasive breast cancer in postmenopausal women who have osteoporosis and/or are at high risk for breast cancer. The drug can cause serious side effects, such as blood clots and stroke, so risks and benefits should be carefully weighed.
The first generic version of carvedilol (Coreg), used to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction after a heart attack.
Levofloxacin (Levaquin) to treat complicated urinary tract infections and acute pyelonephritis at a 750 mg intravenous and oral dose. The drug was already approved to treat other infections.
Internist Archives Quick Links
Sign-up for Physician & Practice Timeline® text alerts and never miss another regulatory deadline!
Triggered text alerts aimed at keeping you on top of upcoming deadlines and details related to regulatory, payment, and delivery system requirements are available FREE of charge!
See sign-up instructions.
Pre-order MKSAP17 Complete and Save 15%!
Enter priority code PR58 when ordering. Limited time only. Order now.