Vioxx, Bextra linked to increased stroke risk: study

NEW YORK (Reuters Health) - Two painkillers pulled from the market in recent years -- Vioxx (also known as rofecoxib) and Bextra (also known as valdecoxib) - increase the risk of stroke, new research indicates.

Vioxx and Bextra were withdrawn from the market “because they increase the risk of cardiovascular events,” lead researcher Dr.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.

To do this, Roumie, of Vanderbilt University, Nashville, Tennessee, and colleagues analyzed six years worth of data on more than 336,000 Tennessee Medicaid enrollees between the ages of 50 and 84 years. Their research focused on the seven most common NSAIDs, including Celebrex (celecoxib), Vioxx, Bextra, ibuprofen, naproxen, indomethacin, and diclofenac.

Among the participants, 78,036 were current users of one of the seven study NSAIDs, 16,420 were current users of other NSAIDs or NSAID combinations, and 242,450 were nonusers (the control group).

Compared with the control group, the risk of stroke was 28 percent higher among Vioxx users and 41 percent higher among Bextra users.

The risk of stroke was not significantly increased with Celebrex or with other NSAIDs.

“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.”

SOURCE: Stroke, July 2008.