July 2008 Journal Article: Bextra And Vioxx Increase Risk Of Cerebrovascular Events, Or Strokes

Study Published In Stroke Shows Risk Not Increased With Celebrex Nor With Other Medications In NSAIDs Class Of Drugs

(Posted by Tom Lamb at DrugInjuryWatch.com)

An article in the July 2008 edition of the medical journal Stroke reports that the COX-2 inhibitors Bextra (valdecoxib) and Vioxx (rofecoxib) significantly increase the risk of cerebrovascular events, commonly referred to as strokes, whereas another COX-2 drug, Celebrex (celecoxib), apparently does not.

The July 2008 Stroke article, "Nonaspirin NSAIDs, Cyclooxygenase 2 Inhibitors, and the Risk for Stroke", reports on a study of 336,906 patients, with these details taken from its Abstract:

Methods — Retrospective cohort study among Tennessee Medicaid enrollees aged 50 to 84 years between January 1, 1999 and December 31, 2004. Noninstitutionalized persons with continuous enrollment in Medicaid and no stroke or other serious medical illness in the year before cohort entry were included. The 7 most common NSAIDs were examined: celecoxib, rofecoxib, valdecoxib, ibuprofen, naproxen, diclofenac, and indomethacin. Nonuse of NSAIDs was the reference group. Because new use is less susceptible to bias, we conducted a similar analysis confined to new users. The outcome was hospitalization for an incident cerebrovascular event: ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage.

An August 7, 2008 Reuters article, "Vioxx, Bextra linked to increased stroke risk: study", provides some commentary from the lead researcher and summarizes the conclusion of this COX-2 and NSAIDs stroke-risk study:

Vioxx and Bextra were withdrawn from the market "because they increase the risk of cardiovascular events," lead researcher Dr. Christianne Roumie noted in comments to Reuters Health. Her team wanted to determine whether these so-called "COX-2" inhibitors and traditional nonsteroidal anti-inflammatory drugs (NSAIDs) drugs such as naproxen or ibuprofen can also increase the risk of stroke....

"This study suggests that rofecoxib and valdecoxib were associated with higher stoke risk than other NSAIDs," Roumie said in the interview.

"Because of this and other studies, their withdrawal from the market is appropriate and these medications should not be re-introduced, especially since safer alternatives are available," she explained.

"Since all NSAIDs, including coxibs, can raise blood pressure and increase the risk of gastrointestinal bleeding, we believe that caution is warranted, especially with long-term use of these medicines."

As many of you are aware, Vioxx was pulled from the U.S. market in September 2004, and Bextra met a similar fate in April 2005.