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  6. January – March 2012 | Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

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

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 Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of October 25, 2023)

Immune Globulin Intravenous (Human), 10% Liquid
(Privigen)

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.

Updated

Privigen labeling

Iodinated contrast agent products

Thyroid dysfunction (Hyperthyroidism and Hypothyroidism)

Updated

The “Warnings”, “Pediatric Use”, and “Adverse Reactions” sections of the labeling for the iodinated contrast agent products were updated in July 2015, February 2022, and April 2023 to provide revised testing recommendations to monitor for thyroid dysfunction including hypothyroidism.

Example: Conray labeling

FDA Drug Safety Communication: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging, November 17, 2015, updated on March 30, 2022, and again on April 26, 2023.

Lacosamide
(Vimpat)

Toxic epidermal necrolysis
Updated

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
(Methergine)

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)

Montelukast
(Singulair)

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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