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Fact Sheet on FDA’s Quarterly Report of Potential Safety Issues

How drugs in the Quarterly Report are identified

Each year, FDA receives about 400,000 reports of adverse events that people experienced around the same time period in which they were taking a drug. An adverse event report does not establish a causal relationship between the drug and a particular event. Adverse events may range in seriousness from fairly minor events, such as skin rashes, to those which are potentially grave or life-threatening.

Drug safety analysts at FDA study these reports to determine four things:

How serious is the adverse event being reported?
Is FDA receiving a greater number of reports of a particular adverse event than expected for a particular drug?
Is the problem new, or is it a side effect that is already understood and reflected in the drug’s labeling?
Do the reports suggest that the adverse events had a reasonable chance of being caused by the drug?

To study these reports, a review team is assigned to conduct a detailed analysis of the data.

What does the new information released today mean for consumers?

If a drug appears on the AERS-based quarterly report, it means that FDA has begun an analysis to determine whether there is a safety problem. However, depending on the level of analysis completed, it may be too early to know whether there is a safety problem, and FDA’s analysis may ultimately conclude that there is no safety problem.

As FDA completes its analysis of drugs on the list, if a safety problem is found, the agency will take action to protect consumers. Such actions can include requiring the manufacturer to change the drug’s labeling to alert patients to a possible side effect that they may experience after taking the drug or requiring a risk evaluation and mitigation strategy (REMS). In some cases drugs that are associated with serious safety problems may be removed from the market.

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