November 7, 2014 — Yet another study has found evidence that the risk of death increases for stroke survivors who take painkillers in the COX-2 inhibitor class, such as Celebrex and the now-recalled drug Vioxx (rofecoxib).
The study was published online in Neurology. Conclusions were based on data from over 100,000 first-time stroke hospitalizations in Denmark between 2004 and 2012.
Patients currently on a COX-2 inhibitor were 19% more likely to die within 30 days of a stroke, compared to non-users. New users were 42% more likely to die. Older drugs in the COX-2 inhibitor class, such as Lodine (etodolac), increased the risk of death after a stroke by 53%.
The risk disappeared in people who stopped taking the medications. No increased risk of death after stroke was found for painkillers in the non-steroidal anti-inflammatory (NSAID) class, such as ibuprofen (Advil, Motrin) and naproxen (Aleve).
This is not the first time COX-2 inhibitors have been linked to increased cardiovascular risks. In 2004, Merck & Co. pulled Vioxx off the market because it was linked to higher rates of heart attack and stroke. In 2007, the company agreed to pay $4.85 billion to settle 27,000 Vioxx lawsuits.
In 2005, the FDA asked Pfizer to stop selling Bextra (valdexocib) because of the risk of heart attack and stroke. Pfizer’s drug Celebrex (celecoxib) remains on the market, despite similar safety concerns. Celebrex is a COX-2 selective NSAID and it already carries a Boxed Warning about cardiovascular events.
According to warnings from Dr. Ralph Sacco of the University of Miami Miller School of Medicine:
“This large study from Denmark adds to the prior concerns about COX-2 inhibitors and stroke risks. Patients at high risk for stroke should be cautious about taking such medications and should consult their physicians as to the best medications to treat inflammation and pain.”
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