Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2009
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 2009 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 2009
|Product Name: Active Ingredient (Trade)|
or Product Class
|Potential Signal of a Serious Risk/New Safety Information||Additional Information|
(as of February 1, 2013)
|Aliskiren (Tekturna, Tekturna HCT)||Angioedema requiring intubation|
The Adverse Reactions section of the labeling for Valturna was updated August 2010, to include angioedema requiring airway management and hospitalization.
FDA approved Valturna (an aliskiren-containing product) on September 16, 2009. Risk of angioedema was included in the Warnings and Precautions section of the labeling for Valturna.
The Warnings and Precautions section of the labeling for Tekturna was updated November 2009 to include angioedema requiring intubation.
The Warnings and Precautions section of the labeling of all of the antipsychotics has been updated to add agranulocytosis.
Refer to the July 2009 Drug Safety Labeling Changes summary page, listing products with "labeling for the entire class of antipsychotic drugs," on the MedWatch Web site.
|Bumetanide (Bumex)||Serious skin reactions (Stevens-Johnson Syndrome, Toxic epidermal necrosis)|
The Adverse Reactions section of the labeling has been revised to include these serious skin reactions.
|Cisplatin (Platinol)||Leukoencephalopathy||FDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.|
A Boxed Warning and new language has been added to the Warnings and Precautions, Contraindications, and Drug Interactions sections of the Exjade label about these deaths.
A Dear Healthcare Professional Letter was issued on February 17, 2010.
On February 18, 2010, FDA issued a Safety Alert.
|Gabapentin (Neurontin)||Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)|
The Warnings and Precautions section of the labeling for Neurontin was updated August 2011, to include DRESS.
|Imatinib mesylate (Gleevec)||Hearing disorders and hearing loss|
FDA has determined that the current labeling is adequate and that no further regulatory action is needed at this time.
|Immunosuppressants (transplant)||BK virus nephropathy||An FDA Alert was issued July 2009 about labeling changes for immunosuppressant drugs for this event.|
Information for Healthcare Professionals: Immunosuppressant Drugs: Required Labeling Changes
|Natalizumab (Tysabri)||Herpes viral infections||FDA evaluated case reports in AERS and determined that the current labeling, which addresses herpes viral infections in the Warnings and Precautions and Adverse Reactions sections of the labeling, is adequate.|
FDA decided that no action is necessary at this time based on limited available information. FDA is continuing to monitor the issue.
|Oseltamivir phosphate (Tamiflu)||Hypothermia|
The Adverse Reactions section of the labeling for Tamiflu was updated November 2010, to include hypothermia.
|Riluzole (Rilutek)||Interstitial lung disease||The Warnings section of the labeling was updated November 2009 to include Interstitial lung disease. Riluzole (Rilutek) Labeling approved November 16, 2009 (PDF - 121KB).|
|Simvastatin (Zocor) and Diltiazem (Cardizem)||Myopathy due to drug interaction|
The Dosage and Administration, Contraindications, Warnings and Precautions, Adverse Reactions, Drug Interactions, and Use in Specific Populations sections of the labeling for Zocor were updated in June and October 2011.
The Dosage and Administration and Warnings and Precautions sections of the labeling for Zocor were previously updated in April 2010.
The Warnings and Precautions section of the labeling for diltiazem-containing products was updated in November 2010.
|Ticlopidine||Disseminated intravascular coagulopathy||FDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.|