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Early Communication About an Ongoing Safety Review
ROCKVILLE, Md., Aug. 9, 2007--FDA issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, Prilosec and Nexium. The new safety data was from two small long-term clinical studies in patients with severe GERD. In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their gastroesophageal reflux disease (GERD). The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA's preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time. Both drugs are used for the treatment of GERD, esophageal erosions and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Prilosec is also sold over the counter for frequent heartburn. Read more below: http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm072497.htm
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Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk Companies Will Include Boxed Warning on Drug Label The U.S. Food and Drug Administration today announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a "boxed" warning, FDA's strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients. After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. FDA had asked the drug's manufacturers, GlaxoSmithKline and Takeda, to address these concerns. "Under FDA's postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "This new boxed warning addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure." FDA's review of adverse event reports found cases of significant weight gain and edema, warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death. The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments. The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair. FDA's review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA's Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks). For more information, visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109136.htm
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Date Published Title Drug Source
2007-08-09 Early Communication About an Ongoing Safety Review Omeprazole FDA
2007-08-14 Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk Rosiglitazone FDA
2007-08-14 Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk Metformin with Rosiglitazone FDA
2007-08-14 Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk FDA
2007-08-14 Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk Pioglitazone FDA
2007-08-16 Updated Prescribing Information Entecavir FDA
2007-08-17 Very rare, serious, side effect in nursing mothers Codeine FDA
2007-08-17 Very rare, serious, side effect in nursing mothers FDA
2007-09-10 Guidance on use in pregnant women and pediatric patients due to to process impurity FDA
2007-09-13 FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol Manufacturer
2007-09-13 Fentora (fentanyl buccal tablet) and the occurrence of serious adverse events Fentanyl FDA
2007-09-18 New warnings for intravenous and high dose use Haloperidol Manufacturer
2007-09-26 Public Health Advisory for Fentora (fentanyl buccal) Fentanyl FDA
2007-10-01 Early communication of ongoing safety review Alendronate FDA
2007-10-01 Early communication of ongoing safety review Alendronate and Vitamin D FDA
2007-10-01 Early communication of ongoing safety review Etidronic Acid FDA
2007-10-01 Early communication of ongoing safety review Ibandronate Sodium FDA
2007-10-01 Early communication of ongoing safety review Pamidronate Disodium FDA
2007-10-01 Early communication of ongoing safety review Risedronic Acid FDA
2007-10-01 Early communication of ongoing safety review Actonel Plus Calcium FDA
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