The FDA has added certain anticancer drugs to its quarterly Watch List because of reported bullous skin conditions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The anticancer drugs identified are lapatinib (Tykerb), pazopanib (Votrient), sorafenib (Nexavar), and sunitinib (Sutent). These kinase inhibitor products are designed to thwart vascular endothelial growth factor, depriving malignant tumors of new blood vessels.
This does not mean that the FDA has concluded that the drug has the listed risk. Being added to the Watch List means that the FDA has identified a potential safety issue through the FDA Adverse Event Reporting System (FAERS) and is continuing to evaluate the issue to determine whether further action is needed. If the FDA concludes that there is a causal relationship between the drug and the related 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.
The FDA emphasizes that it is not suggesting that doctors should stop prescribing watch list drugs or that patients should stop taking the drugs. Patients who have questions should contact their health care provider. FDA is continuing to evaluate the watch listed drugs and will issue additional public communications as appropriate.
[1] FDA Surveillance "Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between October - December 2013," 04/21/2014.
This does not mean that the FDA has concluded that the drug has the listed risk. Being added to the Watch List means that the FDA has identified a potential safety issue through the FDA Adverse Event Reporting System (FAERS) and is continuing to evaluate the issue to determine whether further action is needed. If the FDA concludes that there is a causal relationship between the drug and the related 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.
The FDA emphasizes that it is not suggesting that doctors should stop prescribing watch list drugs or that patients should stop taking the drugs. Patients who have questions should contact their health care provider. FDA is continuing to evaluate the watch listed drugs and will issue additional public communications as appropriate.
[1] FDA Surveillance "Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between October - December 2013," 04/21/2014.
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