A Novartis AG osteoporosis and bone disease drug called Reclast will see increased warnings on the risk of kidney failure. The U.S. Food and Drug Administration (FDA) has updated the warning for Reclast and the FDA is mandating the use of the warning on the drug itself. Doctors must also screen patients for kidney failure prior to prescribing the use of the potentially Reclast.dangerous drug

The FDA first learned of serious complications in 2009 when the agency received 24 reports of kidney failure following a Reclast infusion. The serious complications have continued, however. Since 2009, there have been 11 reports of fatal kidney failure and nine instances of non-fatal kidney failure. For patients with existing kidney problems, use of the drug Reclast can have life-threatening consequences.

Reclast is an infusion drug given to patients once or twice a year. The prescription drug is used to treat and prevent osteoporosis and Paget's bone disease.

While the warnings for patients with existing kidney problems will now be included on the label of Reclast, doctors also need to monitor patients already on Reclast. Failure to warn a patient about the serious and fatal risks of Reclast can be cause for a medical malpractice suit. Patients who were injured prior to the new warnings may also have a claim against Novartis AG due to the failure to warn of the dangers associated with Reclast in a product liability or dangerous drug lawsuit.

Source: Wall Street Journal "FDA Updates Kidney-Failure Warning for Navartis Bone Drug Reclast" Jennifer Dooren, 9/1/2011