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  6. October – December 2013 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

October – December 2013 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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 October-December 2013 in the FAERS 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 FDA Adverse Event Reporting System (FAERS) October-December 2013

Product Name: Active Ingredient (Trade) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of October 25, 2023)

 

Certain kinase inhibitor products with vascular endothelial growth factor (VEGF)-inhibiting properties:
Lapatinib (Tykerb), Pazopanib (Votrient), Sorafenib (Nexavar), Sunitinib (Sutent)

Bullous skin conditions including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

Updated

The Warnings and Precautions section of the sunitinib labeling was updated June 2014 to include information about severe cutaneous reactions.

Sutent label

The Warnings and Precautions section of the lapatinib labeling was updated December 2014 to include information about severe cutaneous reactions.

Tykerb label

Certain methylphenidate hydrochloride extended-release tablets (generic products for the trade name Concerta)

Lack of therapeutic effect, possibly related to product quality issues

Updated

“FDA changed the therapeutic equivalence rating for two methylphenidate hydrochloride extended-release tablets, and CDER issued notices of opportunity for hearing to withdraw approval of those products. Specifically, on October 18, 2016, FDA published notices of opportunity for hearings on its proposals to withdraw approvals of ANDA 091695, held by Kremers Urban Pharmaceuticals Inc. (now held by Lannett Co. Inc.) (Docket No. FDA–2016–N–3120), for methylphenidate extended-release tablets, and ANDA 202608, held by Mallinckrodt Pharmaceuticals (now held by SpecGx LLC) (Docket No. FDA–2016–N–3118), for methylphenidate hydrochloride extended-release tablets. FDA also revised its draft guidance for industry for bioequivalence testing for methylphenidate hydrochloride extended-release tablets (generics of Concerta).”

Drug Safety and Availability updated November 13, 2014, updated October 17, 2016, and November 4, 2016.

 

 

 
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