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U.S. Department of Health and Human Services

Drugs

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Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 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 July - September 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) July - September 2009

Product Name: Active Ingredient (Trade)
or Product Class
Potential Signal of a Serious Risk/New Safety InformationAdditional Information
(as of February 1, 2013)
Alvimopan (Entereg)Gastrointestinal perforation
FDA approved a Risk Evaluation and Mitigation Strategy (REMS) consisting of a communication plan, elements to assure safe use, and an implementation system in May 2008.
Alvimopan (Entereg) REMS modified February 5, 2009 (PDF - 2.2MB)
Angiotensin-converting enzyme (ACE) inhibitorsAngioedema (requiring intubation)

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

Bendamustine (Treanda)Infusion site extravasation

The Warnings and Precautions section of the labeling was updated to include infusion site extravasation.

Bendamustine (Treanda) Labeling approved February 26, 2010 (PDF - 170KB)

Dexlansoprazole (Kapidex)Name confusion with CasodexFDA has approved a name change for the heartburn drug Kapidex to Dexilant as part of the FDA effort to prevent medication errors.
Doripenem (Doribax)Seizure events, Hepatic events, Thrombocytopenia, Serious skin reactions

FDA has determined that the current labeling is adequate and that no further regulatory action is needed at this time.

Enoxaparin (Lovenox)Catheter thrombosis, Splenic ruptureFDA evaluated case reports in AERS and determined that the current labeling is adequate and no further regulatory action is needed at this time.
HMG-CoA reductase inhibitors “Statins”Cognitive effects

Drug Safety Communication

The Adverse Reactions section of the labeling of all of the statins was updated February 2012 to include the risk of cognitive effects..

Lamotrigine (Lamictal)Central nervous system infection, Aseptic meningitis

FDA Drug Safety Communication

The Warnings and Precautions section of the labeling for lamotrigine products was updated October 2010, to include these risks.

Lamotrigine (Lamictal) Labeling approved October 24, 2010 (PDF - 398KB)

Neuromuscular Blocking AgentsAnaphylactic reactions and potential for cross-reactivity

The Warnings and Precautions and Adverse Reactions sections of the labeling of all of the neuromuscular blocking agents were updated November 2010, to include these risks.

Refer to the November 2010 Safety Labeling Changes summary page, listing products with "severe anaphylactic reactions" on the MedWatch Web site.

Sirolimus (Rapamune)Progressive multifocal leukoencephalopathy (PML)

PML was added to the Warnings and Precautions section of labeling in July 2010.

Tumor Necrosis Factor (TNF) BlockersDemyelinating neuropathy

The Warnings and Precautions section of the labeling of all of the TNF blockers has been updated to include peripheral demyelinating neuropathies.

Enbrel (etanercept) label approved January 25, 2011

Simponi (golimumab) label approved July 29, 2010 (PDF - 444KB).

Remicade (infliximab) label approved December 29, 2010 (PDF - 683KB).

Humira (adalimumab) label approved February 25, 2001 (PDF - 3MB).

Cimzia (certolizumab pegol) label approved July 29, 2010 (PDF - 1.66MB)

Zonisamide (Zonegran)Rhabdomyolysis, Pancreatitis

The Adverse Events section of the labeling for Zonegran was updated January 2012 to include rhabdomyolysis and pancreatitis.

Zonisamide (Zonegran) Labeling approved January 26, 2012 (PDF - 387KB)