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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 by the Adverse Event Reporting System (AERS) between July - September 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 July - September 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) July - September 2010

Product Name: Active Ingredient (Trade) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of February 1, 2013)

Benzonatate
(Tessalon)

Death from accidental ingestion in children

FDA Drug Safety Communication

 

The Warnings and Precautions section of the labeling for Tessalon was updated January 2011, to include accidental ingestion resulting in death in children.

 

Benzonatate (Tessalon) Labeling approved January 20, 2011 (PDF - 663KB).

Dronedarone hydrochloride
(Multaq)
Drug interaction with warfarin (Increased anticoagulant effect)The Drug Interactions section of the labeling for Multaq was updated March 2011, to include the risk of increased anticoagulant effect in patients taking warfarin.

Drodenarone hydrochloride (Multaq) Labeling approved March 11, 2011 (PDF - 199KB)
Epoetin alfa
(Epogen/Procrit)
Possible contamination with glass lamellaeFDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.
Gemcitabine hydrochloride
(Gemzar)
Veno-occlusive liver disease

The Warnings and Precautions and Adverse Reactions sections of the labeling for Gemzar were updated February 2011, to include veno-occlusive liver disease.

Gemcitabine hydrochloride (Gemzar) Labeling approved February 4, 2011 (PDF - 1.6MB)

Lanreotide acetate
(Somatuline depot)
Pancreatitis,
Hemorrhagic and Necrotizing Pancreatitis
The Adverse Reactions section of the labeling for Somatuline depot was updated March 2011, to include the risk of pancreatitis.
 
Lanreotide acetate (Somatuline depot) Labeling approved March 4, 2011 (PDF - 147KB)
Lanthanum carbonate
(Fosrenol)
Swallowing complications,
GI obstruction (attributed to tablet hardness)

The Warnings and Precautions and Adverse Reactions sections of the labeling for Fosrenol were updated April 2011, to include these risks.

 

Lanthanum carbonate (Fosrenol) Labeling approved April 27, 2011 (PDF - 89KB)

Levetiracetam
(Keppra)
Stevens-Johnson’s Syndrome,
Toxic Epidermal Necrolysis

The Warnings and Precautions section of the labeling for Keppra was updated December 2011, to include these serious dermatological reactions.

Levetiracetam (Keppra) Labeling approved December 16, 2011 (PDF - 320KB)

Lithium citrateBrugada Syndrome

The Warnings and Precautions and Adverse Reactions sections of the labeling for Lithium citrate were updated October 2011, to include Brugada syndrome.

 

Lithium citrate Labeling approved October 20, 2011 (PDF - 50KB)

Lopinavir/Ritonavir oral solution
(Kaletra)
Serious adverse events in neonates

FDA Drug Safety Communication

 
The Warnings and Precautions, Dosage and Administration, and Overdosage sections of the labeling for Kaletra were updated February 2011, to include the risk of toxicities associated with the use of Kaletra in neonates.
 
Lopinavir/Ritonavir oral solution (Kaletra) Labeling approved February 24, 2011 (PDF - 591KB)
Octagam 5%, Immune Globulin Intravenous (Human)Thromboembolic adverse events

Thromboembolic adverse events have been reported in increased frequency in association with numerous product lots. The manufacturer has voluntarily withdrawn all lots from the US market: Voluntary Market Withdrawal of Octagam.


FDA is working with the manufacturer as it investigates this finding so appropriate corrective actions can be taken.

Pioglitazone HCl
(Actos)
Rhabdomyolysis

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

Ranolazine
(Ranexa)
Drug interaction with statins (Rhabdomyolysis)

The Drug Interactions section of the labeling for Ranexa was updated July 2011, to include information about limiting the dose of statins with Ranexa.

 

Ranolazine (Ranexa) Labeling approved July 11, 2011 (PDF - 273KB)

Sodium oxybate
(Xyrem)
Death

Updated

FDA Drug Safety Communication

The Contraindications section of the labeling for Xyrem was updated December 2012, to include information about not drinking alcohol when using Xyrem.

Sodium oxybate (Xyrem) Labeling approved December 17, 2012 (PDF - 753KB)

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