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

July – September 2012 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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 - September 2012 in the FAERS 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 FDA Adverse Event Reporting System (FAERS) July - September 2012

Product Name: Active Ingredient (Trade) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of August 26, 2019)

Ofatumumab
(Arzerra)

Viral infections

The Boxed Warning and Warnings and Precautions sections of the labeling for Arzerra and Rituxan were updated September 2013, to include information about Hepatitis B virus reactivation and Progressive Multifocal Leukoencephalopathy (PML)

Ofatumumab (Arzerra) Labeling approved September 24, 2013 (PDF - 373KB)

Rituximab (Rituxan) labeling approved September 24, 2013 (PDF – 1,010KB)

Lacosamide
(Vimpat)

Neutropenia

The Adverse Reactions section of the labeling for Vimpat was updated April 2013, to include information about agranulocytosis.

Lacosamide (Vimpat)Labeling approved April 17, 2013 (PDF – 581KB)
 

Dalfampridine
(Ampyra)

Anaphylaxis

The Contraindications and Warnings and Precautions sections of the labeling for Ampyra were updated January 2013, to include anaphylaxis.

Dalfampridine (Ampyra) Labeling Dalfampridine (Ampyra) Labeling approved January 22, 2013 (PDF - 281KB)

Banana Boat Sunscreen Spray

Flammability

Updated

FDA Consumer Update (FDA Archive)

Drug Safety Recall (FDA Archive)

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