FDA Actions

FDA Actions

The FDA has issued a warning to health care providers regarding the antiplatelet drug clopidogrel (Plavix^®). It is recently been found that up to 14% of the population did not metabolize the drug effectively and may not fully convert the drug to its active form. Clopidogrel is dependent on CYP2C19 and those that genetically lack the enzyme may not convert the drug to its active form. Recent studies have suggested that reduced CYP2C19 activity was associated with higher risk for cardiovascular outcomes. A test is available to identify genetic differences in CYP2C19 function and the FDA is recommending that health care professionals consider use of other antiplatelet medications or use alternative dosing if patients are poor metabolizers. The manufacturer of Plavix is being asked to add a black box warning to the drug labeling to this effect. Previously, it was discovered that some proton pump inhibitors including omeprazole may also inhibit metabolism to the active drug. Meanwhile Eli Lilly's prasugrel (Effient^®), a direct competitor to clopidogrel, is not affected by CYP genetic variants.

The FDA has approved Takeda Pharmaceutical's request to change the name of its proton pump inhibitor dexlansoprazole from Kapidex^® to Dexilant. The change is being made due to several dispensing errors that occurred between Kapidex and the prostate cancer drug Casodex^® (bicalutamide) and the analgesic Kadian^® (morphine).

The FDA has approved a generic version of Boeringer Ingelheim's tamsulosin (Flomax^®) for the treatment of benign prostatic hyperplasia in men. Generic tamsulosin should be available later in 2010.