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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.

[**Despite the disclaimer above, some serious issues had to come up for a drug to land on this list otherwise, all drugs would be on it.--**]

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) orProduct ClassPotential Signal of a Serious Risk / New Safety Information

Additional Information(as of October 15, 2010)

Benzonatate(Tessalon)Death from accidental ingestion in childrenFDA is continuing to evaluate this issue to determine the need for any regulatory action.

Dronedarone hydrochloride(Multaq)Drug interaction with warfarin (Increased anticoagulant effect)

FDA is continuing to evaluate this issue to determine the need for any regulatory action.Epoetin alfa(Epogen/Procrit)

Possible contamination with lamellaeFDA is continuing to evaluate this issue to determine the need for any regulatory action.

Gemcitabine hydrochloride(Gemzar)Veno-occlusive liver diseaseFDA is continuing to evaluate this issue to determine the need for any regulatory action.

Lanreotide acetate(Somatuline depot)Pancreatitis,Hemorrhagic and Necrotizing Pancreatitis

FDA is continuing to evaluate these issues to determine the need for any regulatory action.Lanthanum carbonate(Fosrenol)

Swallowing complications,GI obstruction (attributed to tablet hardness)

FDA is continuing to evaluate these issues to determine the need for any regulatory action.Levetiracetam(Keppra)

s-’s Syndrome,Toxic Epidermal NecrolysisFDA is continuing to evaluate these issues to determine the need for any regulatory action.

Lithium citrateBrugada SyndromeFDA is continuing to evaluate this issue to determine the need for any regulatory action.

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

FDA is continuing to evaluate this issue to determine the need for any regulatory action.Octagam 5%, Immune Globulin Intravenous (Human)

Thromboembolic adverse eventsThromboembolic 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)

RhabdomyolysisFDA is continuing to evaluate this issue to determine the need for any regulatory action.Ranolazine

(Ranexa)Drug interaction with statins (Rhabdomyolysis)FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Sodium oxybate(Xyrem)DeathFDA is continuing to evaluate this issue to determine the need for any regulatory action.