Safety Alerts & Recalls

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Latest Alerts

New Boxed Warning for Oral Sodium Phosphate Bowel Cleansing Products
The FDA has informed the public about reports of sudden kidney injury linked to the use of oral sodium phosphate products for bowel cleansing. Bowel cleansing products are used to cleanse the stool out of your bowel before certain medical procedures, such as a colonoscopy. These products include the prescription products, Visicol and OsmoPrep, and other products available over-the-counter (OTC) without a prescription when used at higher doses, such as Fleet Phospho-soda. Patients at greatest risk for acute kidney problems with the use of these bowel cleansing products include patients who are older than 55, are dehydrated, have a history of kidney problems, have a history of bowel problems or take certain medications that affect kidney function such as diuretic (fluid) pills, angiotensin converting enzyme (ACE) inhibitors (medications that lower blood pressure), angiotensin receptor blockers (ARBs, used to treat high blood pressure, heart or kidney failure), and possibly nonsteroidal anti-inflammatory drugs (NSAIDS, like ibuprofen or other arthritis medications). The FDA is requiring Visicol and OsmoPrep, the two products available by prescription, to contain a Boxed Warning about the risk of developing kidney problems. In light of the risk of acute kidney problems, over-the-counter oral sodium phosphate products like Fleet Phospho-soda should not be used for bowel cleansing. However, the available data do not show a risk of acute kidney injury when these OTC products are used at laxative doses. For more information please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103354.htm
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Blood Thinner Warfarin (Coumadin) Has New Brand Competition
Jantoven and Coumadin are both warfarin, a medicine used to help prevent clots that could cause a stroke. One hospitalized man had been taking Coumadin (warfarin) at home for many years due to an irregular heartbeat which often leads to small clots. While in the hospital, the man continued taking warfarin, but the dose was increased. Upon discharge, he was supposed to continue taking warfarin at the new, higher dose. His doctor gave him a new prescription for warfarin at the higher dose. He had this prescription filled at a different pharmacy than he normally used. The new pharmacy gave him a different brand of warfarin, Jantoven. The man knew Coumadin was warfarin, but he did not know Jantoven was also warfarin. The label on the prescription bottle only said Jantoven. Thinking Jantoven and warfarin were two different medicines, he took them both. He had to be readmitted to the hospital several weeks later when his blood tests showed he was in serious danger of bleeding. This safety alert was originally published on the Institute for Safe Medication Practices (ISMP) ConsumerMedSafety website. For more information please visit: http://www.consumermedsafety.org/articles.asp?p=ma_ma_ar200812004
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Date Published Title Drug Source
2008-12-12 New Boxed Warning for Oral Sodium Phosphate Bowel Cleansing Products Sodium Phosphate and Sodium Biphosphate FDA
2008-12-12 Blood Thinner Warfarin (Coumadin) Has New Brand Competition Warfarin ISMP
2008-11-25 New Safety Information for Phenytoin Phenytoin FDA
2008-11-25 New Safety Information for Fosphenytoin Fosphenytoin FDA
2008-11-25 Recall of Several Lots of Bidex-DMI Cold Medicine with Guaifenesin and Dextromethorphan Guaifenesin with Dextromethorphan FDA
2008-11-25 Recall of Several Lots Zaditor Eye Drops Ketotifen FDA
2008-11-25 Recall of Fenofibrate (Fenoglide) Physician Samples Fenofibrate FDA
2008-11-18 Recall of Several Lots of Perphenazine Perphenazine FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Alendronate and Vitamin D FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Etidronic Acid FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Ibandronate Sodium FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Pamidronate Disodium FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Risedronic Acid FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Actonel Plus Calcium FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Tiludronic Acid FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Zoledronic Acid FDA
2008-11-14 Voluntary Recall of Topical Acne Cream Benzoyl Peroxide FDA
2008-11-14 Recall of Additional Lot of PREMPRO 0.3 mg/1.5 mg EZ-DIAL Dispensers Estrogens Conjugated with Medroxyprogesterone FDA
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Clopidogrel MediGuard CRT
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Esomeprazole MediGuard CRT