• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between April - June 2011

 

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 2011 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 2011

Product Name: Active Ingredient (Trade) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of March 1, 2014)

Anagrelide HCl
(Agrylin) and Aspirin

Drug interaction resulting in hemorrhagic events

The Drug Interactions section of the labeling for Agrylin was updated November 2011, to include information about major hemorrhagic events when Agrylin is administered with aspirin.

Anagrelide HCl (Agrylin) Labeling approved November 22, 2011 (PDF - 100KB)

Asenapine maleate
(Saphris)

Oral blistering,
Oral ulceration,
Oral erosion

The Adverse Reactions section of the labeling for Saphris was updated March 2013, to include application site reactions including oral ulcers, blisters, peeling/sloughing and inflammation.

Asenapine maleate (Saphris) Labeling approved March 21, 2013 (PDF - 352KB)

Bevacizumab
(Avastin)

Osteonecrosis of jaw

The Adverse Reactions section of the labeling for Avastin was updated September 2011, to include osteonecrosis of the jaw.

Bevacizumab (Avastin) Labeling approved September 30, 2011 (PDF - 261KB)

Colistimethate sodium for injection

Deaths due to dosing confusion and medication errors

The Warnings and Precautions section of the labeling for Colistimethate sodium for injection was updated March 2013, to include information about maximum daily dose.

Colistimethate for injection (Coly-Mycin M Parenteral) Labeling approved March 2013 (PDF - 287KB)

ISMP Alert June 29, 2011disclaimer icon

Dronedarone HCl
(Multaq)

Pulmonary toxicity

The Adverse Reactions section of the labeling for Multaq was updated June 2011, to include pulmonary fibrosis and pneumonitis.

Drodenarone HCl (Multaq) Labeling approved June 21, 2011 (PDF - 198KB)

Everolimus
(Afinitor, Zortress)

Acute and chronic pancreatitis,
Gallbladder disorder

Updated

The Adverse Reactions section of the labeling for Afinitor was updated February 2014, to include acute pancreatitis.

Everolimus (Afinitor) Labeling approved February 20, 2014 (PDF - 1.26MB)

FDA is continuing to evaluate gallbladder disorder to determine the need for any regulatory action.

Methotrexate sodium and Proton pump inhibitors

Drug interaction resulting in decreased elimination of methotrexate

The Warnings and Precautions section of the labeling for Methotrexate IV was updated November 2011, to include the risk of methotrexate toxicity when administered to patients receiving proton pump inhibitor therapy.

Methotrexate IV Labeling approved November 1, 2011 (PDF - 240KB)

The Warnings and Precautions section of the labeling for the proton pump inhibitor products was updated in January and February 2012, to include the risk of methotrexate toxicity when administered to patients receiving proton pump inhibitor therapy.

Muscarinic receptor antagonist products

Somnolence

The Warnings and Precautions section of the labeling for Enablex was updated March 2012, to include somnolence.

Darifenacin extended-release tablets (Enablex) Labeling approved March 15, 2012 (PDF - 486KB)

The Adverse Reactions section of the labeling for Vesicare was updated January 2012 to include somnolence.

Solifenacin succinate (Vesicare) Labeling approved January 17, 2012 (PDF - 298KB)

The Warnings and Precautions section of the labeling for Sanctura was updated July 2012, to include somnolence.

Trospium chloride (Sanctura) Labeling approved July 23, 2012 (PDF - 498KB)

Tolterodine tartrate (Detrol) Labeling approved August 1, 2012 (PDF - 320KB)

The Warnings and Precautions section of the labeling for Sanctura XR was updated August 2012, to include somnolence.

Trospium chloride extended-release capsules (Sanctura XR) Labeling approved August 17, 2012 (PDF - 535KB)

The Warnings and Precautions section of the labeling for Detrol, Detrol LA, and Tovias were updated August 2012, to include somnolence.

Tolterodine tartrate extended-release capsules (Detrol LA) Labeling approved August 1, 2012 (PDF - 462KB)

Fesoterodine fumarate (Toviaz) labeling approved August 1, 2012 (PDF – 384 KB)

The Warnings and Precautions section of the labeling for Gelnique was updated October 2012, to include somnolence.

Oxybutynin chloride (Gelnique) Labeling approved October 10, 2012 (PDF - 379KB)

Sodium ferric gluconate complex
(Ferrlecit)

Anaphylactic reactions

The Warnings and Precautions section of the labeling for Ferrlecit was updated August 2011, to include anaphylaxis and serious hypersensitivity reactions.

Sodium ferric gluconate complex (Ferrlecit) Labeling approved August 25, 2011 (PDF - 120KB)

Voriconazole
(Vfend)

Fluorosis and Periostitis with long-term use

The Adverse Reactions section of the labeling for Vfend was updated November 2011, to include fluorosis and periostitis.

Voriconazole (Vfend) Labeling approved November 16, 2011 (PDF - 886KB)