Post-Withdrawl Study Confirms Vioxx, Bextra Link To Stroke Risk

Arthritis painkiller, Vioxx was pulled from the market in 2004 after it was linked to an increase in heart attack and stroke. 

Drug maker, Merck will soon begin issuing checks from the $4.85 billion settlement it’s set aside for thousands of victims of Vioxx.  

Now a new study is adding to the evidence that Vioxx (rofecoxib) and withdrawn drug, Bextra (valdecoxib), both so-called “Cox-2” inhibitors, should never have been approved by the FDA.    

Dr. Christianne Roumie of Vanderbilt University in Nashville, wanted to determine whether they, along with the non-steroidal anti-inflammatory drugs (NSAIDS) can also increase the risk of stroke. She and her colleagues studied six years of data on 336,000 Tennessee Medicaid enrollees. They ranged in age from 50 to 84 years. 

The drugs considered were the most common NSAIDS, including Vioxx, Celebrex, Bextra, ibuprofen, naproxen, indomethacin, and diclofenac.  Among participants more than 78,000 were current users of one of the seven. 

Also included were more than 16,000 patients taking other NSAIDS or NSAID combinations.  They were compared to a control group not taking drugs of more than 242,000 participants.

The risk of stroke for the Vioxx users was 28 percent higher compared to the control group.  The risk of stroke was 41 percent higher among Bextra users when compared to the control group.

Among those taking Celebrex or with other NSAIDs there was no significant increase in the risk of stroke. 

Dr. Roumie tells Reuters Health in an interview, that the withdrawl of Vioxx and Bextra from the market was appropriate and that they should not be reintroduced.

“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."  

A study published in the New England Journal of Medicine last year by Oxford University researchers, showed that 16 of 23 cardiovascular events occurred in the Vioxx patients, half within 12 months of taking the drug.  Merck had argued that patients were not at additional risk from Vioxx unless they took the drug for 18 months.

"It would appear...that patients do not need to take rofecoxib (Vioxx) for 18 months to be at increased risk of a cardiovascular thrombotic event," the authors wrote. #