Two Food and Drug Administration (FDA) advisory committees were split on whether data from an analysis of multiple clinical trials showed an increased risk of cardiovascular events in people using common painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
The FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee met jointly to review data and determine whether naproxen was less dangerous to the heart than other NSAIDs such as ibuprofen and Celebrex, as the journal The Lancet suggested. Naproxen is sold as a prescription drug under the name Naprosyn and over-the-counter under the brand name Aleve. Ibuprofen is marketed over-the-counter as both Advil and Motrin, and as a prescription under the name Celebrex.
The committees found that there was not enough data to differentiate between the types of NSAIDs, and that all NSAIDs were associated with an increased risk of gastrointestinal events. The panel also found that while the data “hints” at a relative benefit of naproxen over other NSAIDs, it isn’t enough to warrant any label changes.
The FDA will take the committee’s discussions and opinions under advisement as it makes its own decision whether to add warnings to the labels of NSAIDs. The agency is not required to follow its panels’ advice but it usually does.
NSAIDS are a widely used treatment for pain including that associated with osteoarthritis and rheumatoid arthritis. The committee observed that the potential cardiovascular risks associated with the drugs could be a treatment barrier for many patients. They stressed the need for physicians to discuss the risk of cardiovascular events with patients who are candidates for NSAIDs.
“While we still need to determine how to best manage the (cardiovascular) risk, we can manage the more common risk of (gastrointestinal) events through gastroprotection,” says Alfonso Bello, director of clinical research, Illinois Bone and Joint Institute and clinical associate professor of medicine, University of Illinois College of Medicine.
Source: The Pharma Letter