Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between January – March 2012

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 January - March 2012 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) January - March 2012

Product Name: Active Ingredient (Trade) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of March 1, 2014)

Immune Globulin Intravenous (Human), 10% Liquid

Hemolysis, hemolytic anemia. The majority of cases reported have occurred in patients with non-O blood type and/or receiving doses of ≥2g/kg.

The labeling for Privigen was modified in April 2012 to include information on risk factors for hemolysis.

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

Iodinated contrast agent products

Thyroid dysfunction (Hyperthyroidism and Hypothyroidism)

FDA is continuing to evaluate these issues to determine if the current labeling, which contains information about thyroid dysfunction, is adequate.


Toxic epidermal necrolysis


The Adverse Reactions section of the labeling for Vimpat was updated September 2013, to include toxic epidermal necrolysis.

Lacosamide (Vimpat) Labeling approved September 25, 2013 (PDF - 581KB)

Methylergonovine maleate tablets and injection

Myocardial ischemia and infarction associated with Methergine-induced vasospasm.
Medication errors involving neonates and adults.

The Warnings and Precautions and Adverse Reactions sections of the labeling for Methergine were updated June 2012, to include safety information about cardiac ischemia and heart attack (myocardial infarction) in patients with coronary artery disease or cardiac risk factors who use methylergonovine.
A new warning about medication errors involving inadvertent administration of Methergine to newborn infants was also added to the Warnings and Precautions section of the labeling.
Methylergonovine maleate (Methergine) Labeling approved June 25, 2012 (PDF - 191KB)


Stevens-Johnson Syndrome (SJS)

The Adverse Reactions section of the labeling for Singulair was updated September 2012 to include Stevens-Johnson Syndrome.

Montelukast (Singulair) labeling approved September 27, 2012 (PDF - 262KB)


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