The Food and Drug Administration has taken new action to strengthen existing warning labels about the increased risk of heart attack or stroke with the use of prescription and over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs.
In a July 9 drug safety communication , the agency did not provide the exact language that will be used on NSAID labels, but said that they “will be revised to reflect” information describing that:
• The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID.
• The risk may increase with longer use and at higher doses of the NSAID.
• The drugs can increase the risk of heart attack or stroke even in patients without heart disease or risk factors for heart disease, but patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use.
• Treatment with NSAIDs following a first heart attack increases the risk of death in the first year after the heart attack, compared with patients who were not treated with NSAIDs after their first heart attack.
• NSAID use increases the risk of heart failure.
The new wording will also note that although newer information may suggest that the risk for heart attack or stroke is not the same for all NSAIDs, it “is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.”
The update to NSAID labels goes against the recommendations given by panel members from a joint meeting of the FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee in February 2014 in which they said that the evidence about potentially new cardiovascular risks with NSAIDs that had been presented to them over the 2-day meeting was not sufficient to change labeling. The panelists also voted that there were not enough data to suggest that naproxen presented a substantially lower risk of CV events than did either ibuprofen or selective NSAIDs, such as cyclooxygenase-2 inhibitors.
The FDA made its decision based on a comprehensive review of the data presented during that meeting.
