Potential Signals of Serious Risk Identified by the FDA Adverse Reporting System Release for April through June 2021
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Every couple of months, the Food and Drug Administration (FDA) releases a report identifying some prescription drugs that may have potential safety risks associated with the product based on data collected from the FDA's Adverse Event Reporting System (FAERS). From there, the FDA will collect additional data, determine whether the drug is associated with the risk, and may take regulatory action if needed.
However, it should be noted that just because a drug is listed on the report does not mean the FDA has determined that drug has the potential associated risk. Patients should contact their health care provider for any questions related to their use of any identified drug.
The most recent Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) report (current as of 09/30/2021), is for April through June of 2021. The report shows the prescription drug product name, the active ingredient, product class, new safety information, and any relevant additional information from the FDA.
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In the most recent FAERS report, the FDA identified several prescription drug products that the FDA is currently evaluating the need for regulatory action. The FAERS report is listed alphabetically by product name while listing the active ingredient in parentheses. The next column identifies the potential signal of a serious risk, as well as any new safety information. Finally, the last column will provide any additional information, typically this is where the FDA states where they stand in terms of regulatory action. The April through June 2021 FAERS report data is current as of September 30, 2021.
As always, we will continue to monitor the FAERS quarterly reports and will provide you with any new or relevant information.
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