The list has been published under laws brought in last September that require the FDA to inform the public of new safety information or potential signals of serious risk.
Information is to be published each quarter detailing drugs that have been identified as having potential safety issues based on reports in the FDA’s Adverse Event Reporting System (AERS).
The list is intended to inform patients of potential safety issues and the agency has been keen to stress that there is no definite or casual relationship between the listed drugs and their risks.
Clarifying this point is intended to reassure patients taking drugs on the list to continue doing so. If patients stopped taking medications as a result of the list it would potentially be harmful to themselves and the industry.
The list is part of the FDA’s goal of improving communication with patients but could cause more harm than good if incorrectly interpreted.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said: “Over the past two years, the FDA has become much more proactive in our communication about possible safety problems. 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.”
Listed this quarter are 20 drugs along with the potential associated safety issue. Included on the list are heparin, Tysabri (natalizumab) and Cymbalta (duloxetine).
FDA reviewers select the products based upon millions of adverse events that are submitted to the agency by drug manufacturers, health care professionals and patients.
By analysing the frequency and severity of a drugs appearance in AERS reports the reviewers establish whether it merits being included on the list.
A new report will be published for each quarter, containing only information on new safety information or potential risks identified during the previous six months.
The full list can be found here.