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Some NSAIDs Associated with Vascular and Gastrointestinal Risks

Jun 6, 2013

A recent study found that some nonsteroidal anti-inflammatory drugs (NSAIDs) were associated with increased vascular and gastrointestinal risks. The popular painkillers – which are used by millions for headaches, minor pain, arthritis, fever, and reducing swelling – include nonprescription aspirin, ibuprofen (Advil, Motrin), and naproxen (Aleve); prescription medications include COX-2 inhibitors, such as Celebrex (celecoxib). COX-2 is an enzyme related to pain and inflammation.

The meta-analysis reviewed over 750 NSAID trials and looked at drugs such as diclofenac, selective COX-2 inhibitors (coxibs), ibuprofen, and naproxen, according to the Drug Safety Monitor/The AdverseEvents Research Team, citing a Forbes report.

Coxibs include Celebrex, Bextra (valdecoxib), and Vioxx (rofecoxib); Bextra was withdrawn in 2005 and Vioxx in 2004 owing to increased and significant cardiovascular events, including heart attack and stroke. Diclofenac is sold under the brands Cambia, Cataflam, Felctor, Pennsaid, Voltaren, Voltaren XR, and Zipsor, said the Drug Safety Monitor.

A study just published in The Lancet revealed that coxibs and diclofenac were associated with about a 30 percent increased risk for serious vascular events, primarily coronary events. Diclofenac and coxib medications were also associated with increased risks for vascular death, according to the Drug Safety Monitor. The Ibuprofen was associated with increased risks for major coronary events. Every NSAID studied was linked to gastrointestinal complications; coxibs were associated with the smallest risk, according to the Drug Safety Monitor.

The study group described major vascular events as non-fatal myocardial infarction, non-fatal stroke, or vascular death. Major coronary events were identified as non-fatal myocardial infarction or coronary death, according to Drug Safety Monitor. Using FDA Adverse Event Reporting System (FAERS) data from November 1, 1997, through August 27, 2012, that was aggregated and standardized by the AdverseEvent RxFilter process, the research team found that:

  • Celebrex was the primary culprit in 5,344 cases of heart attack and 990 cases of gastrointestinal complications.
  • Diclofenac was the primary suspect in 78 cases of heart attack and 275 cases of gastrointestinal complications.
  • Aleve was the primary suspect in 114 cases of heart attack and 748 cases of gastrointestinal complications.
  • Advil, Caldolor, Midol Liquid Gels, and Motrin IB (ibuprofen) were the primary suspects in 69 cases of heart attack and 559 reports of gastrointestinal complications.

Another recent study linked NSAIDs to higher death risks and risks for second heart attacks. Prior studies have seen links between birth defects and prenatal use of NSAIDs, as well as links between the class of drugs and increased risks for prostate and kidney cancers. Regular aspirin use has also been associated with an increased risk of neovascular age-related macular degeneration. Also, the American Heart Association issued a statement in 2007 urging physicians to use caution when considering NSAIDs for patients with a history of, or high risk for, cardiovascular disease.

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