Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2010
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 2010 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 2010
|Product Name: Active Ingredient (Trade) or Product Class||Potential Signal of a Serious Risk / New Safety Information||Additional Information|
(as of August 1, 2013)
Clindamycin injection (Cleocin)
Overdose due to labeling confusion/medication errors
The presentation of strength and concentration on the carton and container labeling for Cleocin was updated October 2010.
Stevens Johnson Syndrome,
The Adverse Reactions section of the labeling for Doryx was updated March 2011, to include Stevens Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.
Torsade de Pointes
FDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.
Etonogestrel implant (Implanon, Nexplanon)
The Adverse Reactions section of the labeling for Implanon was updated February 2012, to include convulsions.
The Adverse Reactions section of the labeling for Nexplanon was updated May 2011, to include convulsions.
Hepatitis B reactivation
The Warnings and Precautions section of the labeling for Afinitor was updated July 2010, to include Hepatitis B reactivation.
The Adverse Reactions section of the labeling for Uloric was updated January 2011, to include hypersensitivity. FDA is continuing to monitor this issue to determine the need for any further regulatory action.
Ferumoxytol injection (Feraheme)
Serious cardiac disorders
The Adverse Reactions section of the labeling for Feraheme was updated November 2010, to include serious cardiac disorders.
Hyperinsulinemia, Arterial thrombosis
The Warnings and Precautions section of the labeling of all of the GnRH Agonists has been updated to add hyperinsulinemia and arterial thrombosis.
An update was issued by FDA on October 20, 2010 to the FDA Drug Safety Communication issued in May 2010.
Lanthanum carbonate (Fosrenol)
The Warnings and Precautions, Adverse Reactions, and Contraindications sections of the labeling for Fosrenol were updated March 2011, to include intestinal obstruction.
Proton Pump Inhibitors (PPIs)
The Warnings and Precautions section of the labeling of all of the proton pump inhibitors has been updated to include hypomagnesemia.
Saquinavir mesylate (Invirase)
Prolonged QT and PR Syndromes
An update was issued by FDA on October 21, 2010 to the FDA Drug Safety Communication issued in February 2010.
The Warnings and Precautions section of the labeling for Invirase was updated October 2010, to include QT and PR interval prolongation.
Muscle injury with 80mg dose
The Dosage and Administration, Contraindications, and Warnings and Precautions sections of the labeling for Zocor were updated June 2011, to include information about muscle injury with the 80 mg dose.
Tapentadol hydrochloride (Nucynta)
Convulsions, Hallucinations, Serotonin syndrome
The Adverse Reactions section of the labeling for Nucynta was updated January 2011, to include hallucinations.
FDA is continuing to evaluate these issues to determine the need for any further regulatory action.
Neonatal pulmonary hypoplasia
A Black Box Warning for Embryo-Fetal Toxicity was added to the labeling for Herceptin October 2010, including updates to the Warnings and Precautions, and Use in Specific Populations sections of the labeling, for this issue.