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U.S. Department of Health and Human Services

Drugs

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Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between October - December 2010

 

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period October-December 2010 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) October - December 2010

 

Product Name: Active Ingredient (Trade) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of February 1, 2013)

Asenapine maleate
(Saphris)

Hypersensitivity

FDA Drug Safety Communication

The Warnings and Precautions, Adverse Reactions, and Contraindications sections of the labeling for Saphris were updated August 2011, to include hypersensitivity.

Asenapine maleate (Saphris) Labeling approved August 9, 2011 (PDF - 344KB) 

Dronedarone HCl
(Multaq)

Liver failure

FDA Drug Safety Communication

The Warnings and Precautions and Adverse Reactions sections of the labeling for Multaq were updated February 11, 2011, to include liver failure.

Dronedarone HCl (Multaq) Labeling approved February 11, 2011 (PDF - 198KB)

Fenofibrate products

Paradoxical decrease in HDL cholesterol

Updated

The Warnings and Precautions and Adverse Reactions sections of the labeling for Trilipix were updated September 2012, to include paradoxical decrease in HDL cholesterol.

Fenofibric acid (Trilipix) Labeling approved September 5, 2012 (PDF - 1.64MB)

Paradoxical decrease in HDL cholesterol was added to the Warnings and Precautions and Adverse Reactions sections of the labeling for all fenofibrate products.

FDA Drug Safety Labeling Changes December 2012

Golimumab
(Simponi)

Hypersensitivity reactions and anaphylaxis

The Warnings and Precautions and Adverse Reactions sections of the labeling for Simponi were updated August 2011, to include the risks of hypersensitivity reactions and anaphylaxis.

Golimumab (Simponi) Labeling approved August 17, 2011 (PDF - 185KB)

Ibuprofen lysine
(Neoprofen)

Serious skin reactions (in pediatric patients)

Updated

FDA decided that no action is necessary at this time based on available information.

Morphine sulfate; Naltrexone HCl
(Embeda)

Withdrawal symptoms (not associated with misuse)

FDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.

Oxycodone HCl controlled-release tablets
(Oxycontin)
[new formulation]

Choking and gastrointestinal obstruction

The Dosage and Administration and Adverse Reactions sections of the labeling for Oxycontin were updated November 2010, to include the risks of choking and gastrointestinal obstruction.

Oxycodone HCl (Oxycontin) Labeling approved November 15, 2010 (PDF - 252KB)

Regadenoson
(Lexiscan)

QT prolongation

The Adverse Reactions section of the labeling for Lexiscan was updated September 2011, to include QT prolongation.

Regadenoson (Lexiscan) labeling approved September 23, 2011 (PDF - 189KB)

Sevelamer HCl
(Renagel)

Choking (esophageal obstruction)

The Warnings and Precautions and Adverse Reactions sections of the labeling for Renagel were updated November 2010, to include the risks of choking and obstruction.

Sevelamer HCl (Renagel) Labeling approved June 16, 2011 (PDF - 144KB)