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 July - October 2011 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) July - September 2011
|Product Name: Active Ingredient (Trade) or Product Class||Potential Signal of a Serious Risk / New Safety Information||Additional Information|
(as of January 12, 2017)
The Warnings and Precautions section of the labeling for Humira was updated December 2011, to include optic neuritis.
Clevidipine butyrate IV emulsion
Hypoxemia (decreased oxygen saturation)
The Adverse Reactions section of the labeling for Cleviprex was updated December 2011, to include decreased oxygen saturation.
Dabigatran etexilate mesylate
Bleeding events including hemorrhage with fatal outcome
The Dosage and Administration section of the labeling for Pradaxa was updated January 2012 to include information about monitoring renal function in patients taking dabigatran and adjusting dose if necessary, because dabigatran’s anticoagulant activity and half-life are increased in patients with renal impairment.
Propylene glycol toxicity
The “Precautions” section of the labeling was updated to include propylene glycol toxicity.
FDA decided that no action to revise the current labeling for Alli, which included kidney stones, is necessary at this time based on available information. FDA is continuing to monitor this issue.
The Warnings and Precautions and Adverse Reactions sections of the labeling for Xenical (the prescription orlistat product) were updated January 2012 to include increases in urinary oxalate.
Topical analgesic nonprescription monograph products containing Menthol, Methyl salicylate, and Capsaicin
Application site burns
FDA is continuing to evaluate this issue to determine if the current labeling for the monograph products is adequate.
Tumor Necrosis Factor (TNF) blocking agent products
| The Adverse Reactions section of the labeling for Humira was updated May 2012, to include sarcoidosis. |
Adalimumab (Humira) Labeling approved May 24, 2012 (PDF - 2.12MB)
The Adverse Reactions section of the labeling for Remicade was updated October 2011, to include sarcoidosis.
The Adverse Reactions section of the labeling for Enbrel was updated December 2012, to include sarcoidosis
The Adverse Reactions section of the labeling for Cimzia was updated November 2012, to include sarcoidosis
The Adverse Reactions section of the labeling for Simponi was updated November 2012, to include sarcoidosis.
The Boxed Warning, Warning and Precautions and Contraindications sections of the labeling for Valproate products were updated July 2013, to include information about the risk of hepatotoxicity in children with mitochondrial disorders.
FDA is continuing to evaluate this issue to determine the need for any regulatory action.