Safety Alerts & Recalls

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Latest Alerts

New Safety Warning for Zonisamide/Zonegran
The FDA has announced that zonisamide (Zonegran), a treatment for seizures, can cause metabolic acidosis and is recommending that all patients taking zonisamide (Zonegran) receive periodic blood work to monitor for this condition. Metabolic acidosis is a rare, but serious condition that causes increased acidity of the blood and can result in difficulty breathing and other symptoms such as fatigue, loss of appetite, or confusion. Long-term metabolic acidosis may cause problems with the kidneys and bones. Patients with certain conditions such as kidney problems, severe lung problems, diarrhea, surgery, ketogenic diet, or certain other drugs may be at greater risk for developing metabolic acidosis following treatment with zonisamide. The risk of zonisamide-induced metabolic acidosis appears to be more common and severe in younger patients. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm095251.htm
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Boxed Warning Added to Metoclopramide Labeling
The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide (also sold as the brand name Reglan) must add a boxed warning to the drug label about the risk of its long-term or high-dose use. { drug_name } is FDA approved for short-term use, up to 12 weeks, for stomach and intestinal symptoms of gastroesophageal reflux and symptoms of diabetes-associated delayed gastric emptying, such as nausea, vomiting, heartburn, persistent fullness after meals and loss of appetite. Long-term use of { drug_name } has been linked to a rare but serious condition called tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drug is no longer taken. There is no known treatment for tardive dyskinesia and in some patients, the symptoms do not go away even when the drug is stopped. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm106942.htm
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Date Published Title Drug Source
2009-02-24 New Safety Warning for Zonisamide/Zonegran Zonisamide FDA
2009-02-26 Boxed Warning Added to Metoclopramide Labeling Metoclopramide HCl FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Testosterone FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Clonidine FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Nitroglycerin FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Nicotine FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Scopolamine FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Estradiol and Norethindrone FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Methylphenidate FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Fentanyl FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Estradiol FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Ortho Evra FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Oxybutynin FDA
2009-03-20 Insulin Pens and Insulin Cartridges Must Not Be Shared Insulin FDA
2009-03-20 Insulin Pens and Insulin Cartridges Must Not Be Shared Insulin Aspart FDA
2009-03-20 Insulin Pens and Insulin Cartridges Must Not Be Shared Insulin Glargine FDA
2009-03-20 Insulin Pens and Insulin Cartridges Must Not Be Shared Insulin Lispro FDA
2009-03-20 Several lots of DAYTRANA (methylphenidate transdermal system) Voluntarily Recalled Methylphenidate Manufacturer
2009-03-24 Recall on Single Lot of Propafenone 225 mg Tablets Propafenone FDA
2009-04-01 National Recall on Caraco Brand Digoxin Digoxin Manufacturer