Safety Alerts & Recalls

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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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Date Published Title Drug Source
2011-09-01 FDA Adds Warning of Risk of Kidney Failure With Use of Reclast (Zoledronic Acid) Zoledronic Acid FDA
2011-08-27 Abnormal Heart Rhythms Associated with High Doses of Citalopram (Celexa) Citalopram FDA
2011-08-16 McNeil Recalls Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps Tylenol Cold Multisymtom Plus Coug Manufacturer
2011-08-16 Taro Pharmaceuticals Recalls Select Lots of Fluorouracil Topical Cream, 5% Fluorouracil FDA
2011-08-16 Dr. Reddy's Laboratories Inc. Recalls Simvastatin Tablets Due To Musty Smell Simvastatin FDA
2011-08-16 Teva Pharmaceuticals Recalls Several Lots of Risperidone 0.25 mg, 0.5 mg, 1 mg, 2 mg and 3 mg Tablets Risperidone FDA
2011-08-16 Kimberly-Clark Corp. Recalls Several Lots of KimVent Oral Care Kits with Chlorhexidine Gluconate Solution 0.12% Chlorhexidine FDA
2011-08-16 Hi-Tech Pharmacal Recalls Single Lot of Chlorhexidine Gluconate Oral Rinse, 0.12% Chlorhexidine FDA
2011-08-16 Novartis Pharmaceuticals Recalls Single Lot of Enablex Darifenacin FDA
2011-08-16 Corepharma Recalls Several Lots of Potassium Citrate Extended-Release Tablets Potassium Citrate FDA
2011-08-05 FDA Updates Safety Review For Recombinant Human Growth Hormone (Somatropin) Somatropin FDA
2011-08-03 FDA Warns: Risk of Birth Defect with Long-Term, High-Dose Fluconazole During Pregnancy Fluconazole FDA
2011-08-03 Hetero Drugs Limited Recalls Single Lot of Torsemide tablets, 100 mg Torsemide FDA
2011-08-03 Vintage Pharmaceuticals Recalls Single Lot of Q-Tapp DM Liquid Poly-Histine-DM FDA
2011-08-03 Vintage Pharmaceuticals Recalls Select Lots of CODITUSS DM Liquid FDA
2011-08-03 Vintage Pharmaceuticals Recalls Select Lots of Q-Tussin DM and Iophen DM-NR Liquid Guaifenesin with Dextromethorphan FDA
2011-08-02 FDA Report Cites Customer Complaints of Shrink Wrap Found in Vaccine Vials Human Papilloma Virus Quadrivalent (Types 6, 11, 16, and 18) Vac FDA
2011-08-01 McNeil Lowers Maximum Tylenol Dose to Prevent Overdoses Acetaminophen Manufacturer
2011-07-27 FDA Warns of Possible Serious Neurological Reactions When Linezolid (Zyvox) Is Given To Patients Taking Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Linezolid FDA
2011-07-27 FDA Warns of Possible Serious Neurological Reactions When Methylene Blue Is Given To Patients Taking Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Methylene Blue FDA