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  6. April - June 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)

April - June 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 April - June 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) April - June 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)

Cetirizine HCl
(Zyrtec)

Oculogyric crisis

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

Codeine sulfate

Respiratory depression or arrest resulting in death in children taking codeine who are CYP2D6 ultra-rapid metabolizers.

FDA Drug Safety Communication (FDA Archive)

The Boxed Warning, Contraindications, and Warnings and Precautions sections of the labeling for codeine sulfate products were updated May 2013, to include information about respiratory depression or death following the use of codeine-containing products for pain relief in children.

May 2013 Drug Safety Labeling Changes summary page summary page (FDA Archive)

Docetaxel

Drug interaction with Dronedarone HCl resulting in death

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

Fluoroquinolone products

Retinal detachment

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

Levetiracetam
(Keppra)

Potential for drug abuse, misuse, or dependence

FDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor this issue.

Mefloquine HCl
(Lariam)

Vestibular disorder

Updated

The Boxed Warning, Precautions, and Adverse Reactions sections of the labeling for mefloquine HCl were updated July 2013, to include information about neuropsychiatric events.

Mefloquine label  

Mefloquine Drug Safety Communication (7/29/2013)

Olmesartan medoxomil
(Benicar)

Malabsorption resulting in severe diarrhea and weight loss.

FDA Drug Safety Communication

The Warnings and Precautions and Adverse Reactions sections of the labeling for Benicar were updated July 2013, to include information about severe diarrhea and weight loss.

Olmesartan medoxomil (Benicar) labeling approved July 3, 2013 (PDF - 370KB)

 Proton pump inhibitors
(PPIs)

Pneumonia

Updated

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

FDA Citizen Petition Response Letter October 2014