FDA Initiatives Address Post-Market Safety Concerns


An FDA report outlines the agency's efforts to step up safety monitoring of drugs once they are on the market.

An FDA report outlines the agency’s efforts to step up safety monitoring of drugs once they are on the market.

In 2010, the FDA received 673,259 voluntary reports of adverse drug reactions, twice the number received in 2005. Meanwhile, the agency released 68 Drug Safety Communications to the public in 2011, 29 more than it issued in 2010.

These figures were included in an April 21, 2012, report outlining the FDA’s strategy for monitoring post-market drug safety. Released by the agency’s Center for Drug Evaluation and Research (CDER), the report aims to show that safety priorities for medicines already on the market are the same as for those still under review.

“Our oversight of the safety of marketed drugs has changed significantly over the past few years,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “This report shows that the quality, accountability, and timeliness of post-market drug safety decisions have been enhanced, and our public communication of this information is more effective.”

The agency’s eagerness to trumpet its attention to post-market drug safety is a reaction to criticism of its effectiveness in this area, according to a Reuters article. In addition to highlighting the agency’s laggardly response to safety concerns regarding Merck & Co’s Vioxx, Reuters cites a 2006 Institute of Medicine report stating that the agency needed to do more to ensure the safety of drugs after they are approved and on the market.

The FDA’s post-market safety efforts were boosted by the Food and Drug Administration Amendments Act of 2007, which allows the agency to require drug safety studies for drugs after they are on the market, as well as to mandate updates to drug labeling to cover new safety information. Since 2008, the FDA has required 65 safety-related labeling changes in addition to those made by drug manufacturers voluntarily. Labeling changes required by the FDA have included reporting increases in blood sugar levels and memory loss and confusion associated with statin use and highlighting the increased risk for childhood cancers from TNF blockers.

Among the agency’s post-market safety efforts is the Safe Use Initiative, which enlists several health services as well as consumers to spot areas where drug misuse could cause harm to patients. Safe Use Initiative efforts have included alerting consumers about acetaminophen toxicity and hidden sources of it, and increasing awareness of the importance of medication adherence. The initiative has helped to double reporting of serious reactions to drugs over a 5-year period, the agency said. The increase has provided the agency with more information for safety assessments and has prompted the implementation of a data-mining algorithm to identify adverse reaction patterns.

The agency’s communication efforts aim to provide more timely and useful safety information to patients and health care professionals. Changes to its communication system include releasing alerts on safety issues as quickly as possible, via Drug Safety Communications. In addition, the agency is studying a variety of communication methods, including website postings, social media, and press releases, to determine the best approaches for reaching different audiences.

Previous coverage of FDA post-market safety actions:

FDA Modifies Statin Label Warnings

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