The FDA has approved a five-day, once-daily IV and oral 750-mg regimen of levofloxacin (generic Levaquin, Ortho-McNeil, PriCara) for patients with complicated urinary tract infections (UTIs) and acute pyelonephritis (kidney infection).
Spontaneous bacterial peritonitis, an infection of ascites, is a common cause of death in patients with cirrhosis. This infection can be cured with antibiotics, but hepatorenal syndrome may develop and patients sometimes die of severe hepatic and renal insufficiency. Therefore, it was thought that preventing spontaneous bacterial peritonitis might increase survival. In fact, primary prophylaxis with norfloxacin drug (Noroxin, Merck) did have a great impact in patients with advanced cirrhosis, according to researchers from Spain. They say that the drug can help significantly prolong survival—especially good news to a patient waiting for a liver transplant.
Thanks to their anti-inflammatory and immunomodulatory effects, statins have been linked to reduced morbidity and mortality caused by infection, including pneumonia. But in a study of older adults, researchers from the University of Washington found no reduced risk of pneumonia among those taking statins.
The FDA has ordered four companies to stop marketing unapproved codeine sulfate tablets. These opioid analgesics are narcotic pain relievers that have not been approved, and there is no evidence that they are safe and effective. The products are as follows:
• Codeine Sulfate Tablets, 30 mg, 60 mg, Lehigh Valley Technologies
• Codeine Sulfate Tablets, 30 mg, 60 mg, Cerovene, Inc.
• Codeine Sulfate Tablets, 30 mg, Dava International, Inc.
• Codeine Sulfate Tablets, 30 mg, 60 mg, Glenmark Generics
The FDA does not anticipate a shortage; Roxane markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug.
Source: FDA, October 13, 2009