VIOXX™ is a non-steroid, anti-inflammatory drug (NSAID – a painkiller) marketed by Merck & Co., Inc., producer of the famous Merck Manuals, and a leading international pharmaceutical company. Merck spends billions each year on drug research and development.
May, 1999 – The FDA approved VIOXX for arthritis, menstrual pain, and other acute pain in adults. It has been marketed in over 80 countries, under the name of CEOXX in some. Chemically, it’s related to ibuprofen and naproxen, both older drugs. VIOXX blocks a certain enzyme which helps cause inflammation and pain, and has been found effective for arthritis and the other conditions it is approved for.
June, 2000 – Merck finished a study called VIGOR (standing for VIOXX Gastrointestinal Outcomes Research). They gave the results to the FDA. Naproxen and VIOXX had been compared and it was found that patients on VIOXX had five more heart attacks than those on Naproxen.
September, 2001 – The FDA sent a warning letter to Merck about the Merck promotional campaign. The FDA thought it was minimizing the risk of heart problems (heart attack and stroke).
April, 2002 – Merck amended the VIOXX package insert to include a warning about potential heart problems.
September, 2004 — Independently of the FDA, Merck announced that it was withdrawing VIOXX from the market because of increased risk of heart problems. A study (called APPROVe) had been ongoing which for the first 18 months came up with no indications of increased cardiac risk. But patients who took VIOXX for longer than 18 months had increased heart problems – overall (not in every case). That APPROVe trial was stopped.
It had begun in 2000, and involved 2,600 patients with a history of colon cancer. It was evaluating the effectiveness of VIOXX in preventing recurrence of intestinal growths. The indications of cardiac risks started appearing 18 months into this trial. Merck decided to withdraw VIOXX rather than amend its labeling.
February, 2005 – The FDA, having had a panel investigating the matter, concluded that VIOXX and the similar drugs (Naproxen and ibuprofen) all increase risks of heart problems, but should still be available on the market.
This space will continue the VIOXX saga by briefly outlining the series of verdicts through 2005 and 2006.
If you have taken VIOXX and then sustained a heart attack or stroke, please feel free to contact us for a free case evaluation.