INFO, HEALTH TIPS AND NEWS

The US Food and Drug Administration (FDA) is warning clinicians against the off-label prescribing of ketoconazole tablets (Nizoral, Janssen Pharmaceuticals) to treat skin and nail fungal infections because the risk for serious liver damage and death outweighs the benefits. In July 2013, the FDA removed skin and nail fungal infections as indications for ketoconazole tablets in light of possible adverse events, which also include adrenal gland problems and harmful interactions with other drugs. The agency revised the label to warn that patients with no obvious risk factors for liver disease had developed serious hepatotoxicity after taking the drug, leading to liver transplants or death in some cases. However, clinicians have continued to prescribe ketoconazole tablets for skin and nail fungal infections despite the label change, according to an FDA safety review. Such infections were the only diagnoses cited for the tablets during 2014 and the first 6 months of 2015, according to a da...

05.12.2016 INFECTIOUS DISEASE WASHINGTON Fluoroquinolone antibiotics, the class that includes ciprofloxacin (Cipro), ciprofloxacin, getifloxacin, ofloxacin, pefloxacin, sparfloxacin, levofloxacin , e.t.c should not be used to treat uncomplicated infections such as sinusitis, bronchitis, and urinary tract infections for which other drug types are effective, the FDA announced Thursday. Only patients with these conditions who can't be treated with other agents should receive fluoroquinolones, the agency said. "An FDA safety review has shown that fluoroquinolones when used systemically (i.e., tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system," the FDA said. Labels and medication guides for these agents will be updated to reflect the review's findings . The FDA noted that it has had ...