Safety Alerts & Recalls

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Latest Alerts

Drug Interaction Warnings Added to Prescribing Information for Seroquel
The FDA has requested that AstraZeneca add a new heart warning to the labels of its antipsychotic medicine Seroquel and the extended-release Seroquel XR. The new prescribing information label will recommend that patients should avoid use of Seroquel and Seroquel XR in combination with 12 drugs linked to abnormal heart rhythms (also known as arrhythmias). The abnormal heart rhythm, known as prolongation of the QT interval, can cause sudden cardiac arrest, a condition where the heart stops beating. The updated prescribing information lists the other drugs to avoid including: antiarrhythmic drugs like quinidine, procainamide, amiodarone (Cordarone, Nextarone, Pacerone) and sotalol (Betapace); antipsychotic drugs like ziprasidone (Geodon), chlorpromazine and thioridazine; antibiotics like gatifloxacin (Zymar, and Zymaxid) and moxifloxacin (Avelox); the anti-infective drug pentamidine (Pentam); and synthetic opioids like levomethadyl acetate and methadone (Dolophine, Methadose). The label also raises caution about use by the aged and people with heart disease. For more information, please visit: http://www.nytimes.com/2011/07/19/health/19drug.html?_r=1
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Dr. Reddy's Laboratories Limited Recalls Single Lot of Quetiapine Tablets, 25mg
Dr. Reddy's Laboratories Limited has recalled a single lot of Quetiapine Fumarate Tablets, 25mg. Lot number C203090 has been recalled because this lot failed the manufacturer’s routine test for stability over time. Quetiapine is used in the treatment of mood and mental disorders. Quetiapine is also sold under the brand name Seroquel and Seroquel XR. No other lots, strengths, or brands of Quetiapine were involved in this recall. To view the FDA notice about this recall, please visit: http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=63524&w=11282012&lang=eng
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Date Published Title Drug Source
2011-07-19 Drug Interaction Warnings Added to Prescribing Information for Seroquel Quetiapine FDA
2012-12-02 Dr. Reddy's Laboratories Limited Recalls Single Lot of Quetiapine Tablets, 25mg Quetiapine FDA
2008-08-12 Angioedema and ACE inhibitors Quinapril MediGuard CRT
2010-07-09 FDA Warns Using Malaria Medication for Leg Cramps Can Lead to Serious Side Effects Quinine Sulfate FDA
2008-09-18 Long-term use of proton pump inhibitors (PPIs) may increase risk of fractures Rabeprazole MediGuard CRT
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Rabeprazole MediGuard CRT
2013-06-10 Nephron Pharmaceuticals Corporation Recalls EZ Breathe Atomizer and Asthmanefrin Starter Kit FDA
2008-07-03 New Consumer Guide for Patients Raloxifene MediGuard CRT
2008-11-10 Postmenopausal Hormone Therapy May Be Associated with Heartburn Raloxifene MediGuard CRT
2008-08-12 Angioedema and ACE inhibitors Ramipril MediGuard CRT
2008-09-18 FDA Stops Imports of Ranbaxy Products Ranitidine FDA
2010-03-31 Recall on a Single Lot of Ranitidine Tablets, 150 mg Ranitidine FDA
2012-09-17 Natural Essentials Recalls Several Lots of Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06% FDA
2008-10-10 Important Information About Safe Use of Children's Cough and Cold Medicine Manufacturer
2008-08-04 Generic Manufacturer Recalls Several Drug Products Rifampin Manufacturer
2008-02-08 Early communication regarding FDA safety review Rimabotulinumtoxinb FDA
2009-05-01 New Boxed Warning Rimabotulinumtoxinb FDA
2009-08-04 FDA Approves Updated Labeling for Botulinum Products Rimabotulinumtoxinb FDA
2007-10-01 Early communication of ongoing safety review Risedronic Acid FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Risedronic Acid FDA
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