Two US Food and Drug Administration (FDA) panels voted to include a warning on the naproxen nonprescription Drug Facts label about the interaction between aspirin and naproxen, and to make no changes to the current ibuprofen nonprescription Drug Facts label that already warns against its use with aspirin, at a joint meeting April 25.
Seven members of the FDA’s Arthritis Advisory Committee (AAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) voted to make no change to the current naproxen Drug Facts label; 12 voted to include a warning on the label about the interaction between aspirin and naproxen; and two voted to add a contraindication for the use of naproxen when taken with aspirin.
“I voted [to include a warning on the label]; I think that the data showed that [naproxen] and ibuprofen are similar, and as such, the labeling should be the same for [naproxen] as ibuprofen,” said voting AAC member Alyce M. Oliver, MD, PhD, professor of medicine, Division of Rheumatology, Medical College of Georgia at Augusta University.
One member changed his vote from adding a warning to the naproxen label to not changing the label. He said that although he felt it was important to keep the labels on ibuprofen and naproxen consistent with one another, he changed his vote because he is reluctant to add too many warnings to package labeling. “I think the warnings in the package label currently are clear, simple, short, and well established. I’m not sure that adding an additional warning that’s not clearly well established serves the public at large,” said temporary voting committee member Steven F. Solga, MD, AGAF, associate professor of clinical medicine, Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
On the two committees, 17 members voted against changing the current ibuprofen Drug Facts label, and four voted to add a contraindication for the use of ibuprofen when taken with aspirin.
“There wasn’t sufficient information, either the biomarkers or the PK [pharmacokinetics], and the clinical data raised issues about how important this was, so there wasn’t enough to move it up or down in terms of risks to modify the label from the current language,” temporary voting member Crag W. Hendrix, MD, Wellcome Professor and director, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, said of his vote against changing the label on ibuprofen to include a contraindication against the concomitant use of aspirin.
PRECISION Study
The April 25 meeting followed a meeting held the previous day, during which the two panels discussed issues related to the cardiovascular safety of celecoxib (Celebrex, Pfizer) — a cyclooxygenase-2 selective nonsteroidal anti-inflammatory drug (NSAID) — relative to the nonselective NSAIDs ibuprofen and naproxen.
Both meetings focused on data from the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen or Naproxen (PRECISION) trial, a postmarketing study requested by the FDA to assess the CV thrombotic risk of celecoxib.
PRECISION was a randomized, double-blind, active-controlled, parallel-group trial that began in 2006 and included 24,081 individuals, all of whom had osteoarthritis or rheumatoid arthritis and had or were at high risk for CV disease.
The study found that celecoxib was noninferior to ibuprofen and naproxen in terms of CV safety.
The results of the PRECISION trial were published online November 29, 2016, in the New England Journal of Medicine and were reported by Medscape Medical News. Findings from that study suggested that aspirin may limit the safety profile of celecoxib.
The FDA has been concerned about the concomitant use of aspirin with ibuprofen and naproxen. “With the focus on a patient population enriched for CVD [cardiovascular disease], about 45% of the study population were taking cardioprotective doses of aspirin. Because ibuprofen and naproxen both act as reversible inhibitors of cyclooxygenase-1 (COX-1), they can interfere with aspirin’s antiplatelet activity (due to irreversible inhibition of COX-1). The NSAID interactions with aspirin had potential clinical implications on the occurrence of the primary study outcome of the APTC [Antiplatelet Trialists’ Collaboration] composite CV endpoint (non-fatal myocardial infarction [MI], non-fatal stroke, CV death),” the FDA explained in a briefing document.
Panel members acknowledged that many individuals with cardiac disorders have chronic or periodic pain for which NSAIDs provide relief. In addition, efforts to curb opioid abuse have increased the use of NSAIDs. Many laypersons may not understand the dangers associated with medications that can be readily purchased over the counter, and others may have difficulty talking with their healthcare providers about alternatives.
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