FDA Adds Warning of Risk of Kidney Failure With Use of Reclast (Zoledronic Acid)
The U.S. Food and Drug Administration (FDA) has approved an update to the drug label for Reclast (zoledronic acid) to better inform healthcare professionals and patients of the risk of kidney (renal) failure. Kidney failure is a rare, but serious, condition associated with the use of Reclast in patients with a history of or risk factors for renal impairment. Risk factors for developing kidney failure include existing poor kidney function, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing kidney failure in patients with existing poor kidney function also increases with age. The revised label states that Reclast should not be used (is contraindicated) in patients with severe kidney disease or in patients with symptoms or signs of sudden kidney problems (acute renal impairment). The label also recommends that healthcare providers screen patients prior to administering Reclast in order to identify at-risk patients and should also monitor how well the kidney works in patients who are receiving Reclast. Reclast contains the active ingredient zoledronic acid and is used to treat or prevent osteoporosis. Reclast is also used to treat men and women who have Paget's disease of the bone. These labeling changes are being made to the Reclast label only. Zoledronic acid is also sold as the brand name Zometa and is approved for treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa label. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm270199.htm
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Abnormal Heart Rhythms Associated with High Doses of Citalopram (Celexa)
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant citalopram (also marketed as the brand name Celexa) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Studies of citalopram doses greater than 40 mg per day have not been shown to have a benefit in the treatment of depression. Changes in the electrical activity of the heart can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be serious and may lead to death. Patients at particular risk for developing abnormal changes in the electrical activity of the heart include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.  The drug labels for Celexa and other citalopram products have been revised to include the new drug dosage and usage recommendations, as well as information about the potential for changes in the electrical activity of the heart and Torsade de Pointes. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm269086.htm
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