If you are seeking information about a potential Vioxx case please call us at (615) 742-1775 or toll-free at (800)-394-2119. You may also e-mail us. We are actively investigating claims on behalf of persons who took Vioxx and have suffered significant injuries.
What You Should Know
In 1999, Merck & Co. introduced and began marketing Vioxx (rofecoxib), which quickly became a hugely popular prescription pain reliever for the treatment of osteoarthritis, acute pain, menstrual pain and rheumatoid arthritis. Vioxx is a non-steroidal anti-inflammatory drug (“NSAID”) known as a COX-2 inhibitor. By early 2000, less than a year after the drug was introduced, a study that monitored over 7,000 patients found that people who take Vioxx have five times greater risk of heart attack than those who take other painkillers. Despite the results of this trial, Merck waited another two years before warning physicians of the cardiovascular risks associated with its multi-billion-dollar-a-year drug. During that time, scores of patients suffered heart attacks and strokes while taking Vioxx.
COX-2 is an enzyme made when cells are injured, which triggers pain and inflammation Merck had hoped that Vioxx would become a “blockbuster drug” to rival Pfizer Inc.’s COX-2 inhibitor Celebrex and other traditional pain relievers such as aspirin and Tylenol. Merck spent hundreds of millions of dollars in advertisements to both doctors and the general public. After $2.5 billion in sales, its use by 80 million people and perhaps 27,000 deaths caused by the drug, Merck took it off the market Sept. 30, 2004. Vioxx had been found to increase the risk of heart attacks and strokes. It was the largest prescription withdrawal in the history of the world. Now the entire class of COX-2 inhibitors has come under scrutiny by the FDA. Recently, Pfizer stopped advertising Celebrex after studies found the drug to pose an increased risk of cardiovascular events.
Even before the FDA gave approval May 21, 1999, for Merck to market Vioxx (rofecoxib) for pain from arthritis, there were red flags. Vioxx is a nonsteroidal anti-inflammatory drug (NSAID). It belongs to a class of drugs known as COX (cyclooxtgenase) 2 enzyme inhibitors. In 1998 a group at the University of Pennsylvania discovered that COX-2 inhibitors interfere with enzymes thought to play key roles in preventing heart attacks. Dr. Garret FitzGerald headed the study and he postulated to Merck, and other companies that were developing COX-2 inhibitors, that use of the drugs could lead to heart attacks and strokes.In early 1999, before the FDA approval, Merck began the so-called VIGOR study (Vioxx Gastrointestinal Outcome Research), which it hoped would show that Vioxx was better than naproxen, an over-the-counter drug, as a painkiller but without the gastrointestinal problems. There were 8,076 patients with rheumatoid arthritis studied in a prospective, randomized, double-blind comparison of Vioxx with naproxen. Dr. Shari Targum of Merck wrote in a Nov. 18, 1999, memo that the data and safety monitoring board of the VIGOR study was concerned over the deaths from cardiovascular events experienced in the Vioxx group over the naproxen group. Then, in December 1999 the FDA sent a warning letter to Merck saying the firm’s promotional materials were “false and misleading.”
Where can I find additional information?
- Representative Vioxx Complaint
- Vioxx News
- Merck Is Looking to Settle Some Vioxx Cases
- 2/11/05: Marketing of Vioxx: How Merck Played Game of Catch-Up
- 2/11/05: FDA Studies Cox-2 Inhibitors
- 2/8/05: Merck Canceled an Early Study of Vioxx
- 2/7/05: Merck Documents Shed Light on Vioxx Legal Battles:Records Show Safety Panel Had Early Data Indicating Higher Heart-Problems Risk (WSJ)