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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 July - September 2011

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 ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of August 1, 2013)

Adalimumab
(Humira)

Golimumab
(Simponi)

Optic neuritis

The Warnings and Precautions section of the labeling for Humira was updated December 2011, to include optic neuritis.

Adalimumab (Humira) Labeling approved December 26, 2011 (PDF - 6MB) disclaimer icon


The Warnings and Precautions section of the labeling for Simponi was updated December 2011, to include optic neuritis.

Golimumab (Simponi) Labeling approved December 26, 2011 (PDF - 2.3MB)disclaimer icon

Clevidipine butyrate IV emulsion
(Cleviprex)

Hypoxemia (decreased oxygen saturation)

The Adverse Reactions section of the labeling for Cleviprex was updated December 2011, to include decreased oxygen saturation.

Clevidipine butyrate IV emulsion (Cleviprex) Labeling approved December 8, 2011 (PDF - 382KB)

Dabigatran etexilate mesylate
(Pradaxa)

Bleeding events including hemorrhage with fatal outcome

FDA Drug Safety Communication
 

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.
 

Dabigatran etexilate mesylate (Pradaxa) Labeling approved January 17, 2012 (PDF - 472KB)
 

Diazepam injection
(Valium)

Propylene glycol toxicity

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Orlistat
(Alli)

Kidney stones

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.
 

Orlistat (Xenical) Labeling approved January 20, 2012 (PDF - 408KB)

Topical analgesic nonprescription monograph products containing Menthol, Methyl salicylate, and Capsaicin

Application site burns

FDA Drug Safety Communication

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

Sarcoidosis

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.

Infliximab (Remicade) Labeling approved October 26, 2011 (PDF - 1.1MB)

FDA is continuing to evaluate this issue to determine the need for any further regulatory action.

Valproate products:
Valproic acid, Divalproex sodium, Valproate sodium

Liver failure,
Liver injury,
(involving hereditary mitochondrial disorders such as Alpers-Huttenlocher Syndrome (AHS), and other conditions)

FDA is continuing to evaluate this issue to determine the need for any regulatory action.