Intended for healthcare professionals


Bringing Vioxx back to market

BMJ 2018; 360 doi: (Published 25 January 2018) Cite this as: BMJ 2018;360:k242
  1. Joseph S Ross, associate professor of medicine1 2,
  2. Harlan M Krumholz, Harold H Hines Jr professor of medicine1 2
  1. 1Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
  2. 2Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, CT, USA
  1. Correspondence to: J S Rossjoseph.ross{at}

Regulatory and transparency safeguards are essential to protect patients

In 1999, the US Food and Drug Administration (FDA) approved rofecoxib (Vioxx) for the treatment of acute pain and the pain associated with osteoarthritis. Its manufacturer, Merck, marketed the drug as an effective, safer alternative to non-steroidal anti-inflammatory drugs (NSAIDs) and obtained subsequent FDA approvals for the treatment of rheumatoid arthritis and migraine. Additional studies were done to examine rofecoxib’s efficacy in delaying the progression of Alzheimer’s disease, preventing adenomatous polyps of the colon, and managing premenstrual acne. By 2003, millions of people were taking the drug and it had accrued more than $2.55bn (£1.8bn; €2bn) in sales.1 However, in September 2004, Merck withdrew rofecoxib from the market after concluding that it was associated with increased cardiovascular risk.1

Now, 14 years later, the small drug company Tremeau Pharmaceuticals has announced plans to bring the drug back to market for severe joint pain caused by haemophilia.2 Aspirin and other NSAIDs are generally not recommended for patients with haemophilia, and the company hopes that rofecoxib might be considered since these patients have fewer options to manage their acute pain. However, although some patients may be willing to accept the associated increased cardiovascular risk, the FDA and other regulators …

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