FDA to Post Quarterly Report of Potential Safety Issues. The first report lists 20 drugs along with the potential safety issue associated with each drug.
In a move that can only help consumers and medical professionals make better decisions about drugs, the U.S. Food and Drug Administration (FDA) announced today that will begin posting lists certain drugs that are being evaluated for potential safety issues on its web site.
The postings will be madequaterly and the first report covers drugs earning a safety concern from January 2008 through March 2008. These drugs have been identified based on a review of reports in FDA’s Adverse Event Reporting System (AERS).
Consumer health advocates have been calling for years for more timely disclosure of information on approved drugs that result in reporting of serious side effects.
Of course, the agency makes it clear that the appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.
“My message to patients is this: Don’t stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.
Drugs that appear on the agency’s new AERS-based table, titled “Potential Signals of Serious Risks/New Safety Information,” are identified by FDA reviewers based on reports from the FDA’s AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.
A new quarterly report listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS will be posted to the FDA’s Web site every three months. The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risks have been identified through AERS during the previous quarter.
“Over the past two years, FDA has become much more proactive in our communication about possible safety problems,” Woodcock said. “Patients and health care professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues.”
The agency expects that posting the list will encourage more reporting of adverse events.
To See the current list click here.