FDA reports on Vioxx

An FDA report published in the Lancet, a British medical journal, found that “Rofecoxib use increases the risk of serious coronary heart disease compared with celecoxib use.

Naproxen use does not protect against serious coronary heart disease.” Rofecoxib is the generic name of Vioxx.

Authored by Dr. David J Graham of the FDA, and others, Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study investigated whether Vioxx caused an increase risk of heart problems, and if naproxen gave any heart benefits. (This question first arose in theVioxx Gastrointestinal Outcomes Research (VIGOR) trial in 2000, but was not followed up on until this report.) Vioxx was also compared with Celebrex, the most similar pain medication on the market.

From a sample size of 6 million, the study researched the medical history of almost 1.4 million Californians who had filled at least one prescription for Vioxx. It found that 8,143 people were admitted with “serious coronary heart disease” – 6,635 had a heart attack and 1,508 had sudden cardiac death. This was higher than the group that took Celebrex, which was in turn higher than the control group that took no pain medication of this class.

It also found that the risk increased after one month of taking Vioxx – the shortest time period measured in the study – and suggested that the risks could increase even sooner. Long-term use of Vioxx and higher doses also increased the risk.

The study did not investigate into strokes and other cardiovascular events that are also suspected to be a result of Vioxx use.

The Discussion section noted several limitations of the study, most notably the fact that the authors did not have access to each patient’s full medical records. Therefore, factors such as a history of heart disease, smoking, and other factors that could contribute to heart disease were not available. But because the study was a comparison, these factors were assumed to be relatively close in all groups.

There is a double importance to this study. First is the confirmation that Vioxx does indeed increase the risk of heart attack, and quite probably stroke and other heart problems. But second it shows a serious crack in the way drugs are developed, tested, and approved in this country. Even after serious concerns were raised in the VIGOR trial, nobody followed up on the findings to confirm or discredit them including the FDA and Merck itself, the two organizations charged with the most responsibility to protect patients from the defects in Vioxx.

The report concluded by saying that: “In the future, when trials such as VIGOR show that a new treatment confers a greater risk of a serious adverse effect than a standard treatment, we must be much more careful about allowing its unrestrained use.”

If you or a loved one has suffered a heart attack, stroke, or other condition while using Vioxx, contact Jim S. Adler & Associates to find out if you are eligible to receive compensation for your injuries. We will give you a free case review and inform you of your rights. With the Personal Injury lawyers of Jim S. Adler & Associates on your side, you have the best chance of getting the settlement you deserve.