On February 4, 2009, the FDA posted updated listings of specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA’s Adverse Event Reporting System. The postings, which are mandated by the Food and Drug Administration Amendments Act of 2007, reflect safety information through September 2008. The FDA cautions that the appearance of a drug on this list does not mean that FDA has concluded that the drug has or causes the listed risk, nor does it suggest that healthcare providers should not prescribe or patients should not take the drug. If the FDA determines after further evaluation that the drug is associated with the risk, FDA could require labeling changes, require development of a Risk Evaluation and Mitigation Strategy (REMS), or gather additional data to better characterize the risk.