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Related Experiment Videos

Worldwide safety experience with nabumetone.

G C Bernhard1

  • 1Arthritis Center, Mills-Peninsula Hospitals, San Mateo, CA 94401.

The Journal of Rheumatology. Supplement
|November 1, 1992
PubMed
Summary

Nabumetone is a safe nonsteroidal anti-inflammatory drug (NSAID) with a low incidence of gastrointestinal ulcers. Clinical trials and postmarketing surveillance confirm its safety profile across diverse patient populations.

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Area of Science:

  • Pharmacology
  • Gastroenterology
  • Clinical Therapeutics

Background:

  • Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID) used for pain and inflammation.
  • Extensive clinical testing, including premarketing and postmarketing surveillance, has been conducted over approximately 10 years.

Purpose of the Study:

  • To evaluate the efficacy and safety of nabumetone.
  • To compare nabumetone's safety profile with placebo, aspirin, and other NSAIDs.

Main Methods:

  • Clinical trials involving 7,241 patients in the United States and other regions.
  • Postmarketing surveillance data from 37,712 patients in the United Kingdom and Germany.
  • Adverse event monitoring, including withdrawal rates, gastrointestinal perforations, ulcers, and bleeds.

Main Results:

  • Withdrawal rates due to adverse effects ranged from 3% to 13%.
  • Cumulative incidence of nabumetone-induced gastrointestinal perforations, ulcers, or bleeds was between 0.02% and 0.95%.
  • No bone marrow suppression, liver necrosis, serious CNS conditions, or life-threatening dermatologic reactions were observed. Toxicity did not increase with dose or age.

Conclusions:

  • Nabumetone is determined to be a safe NSAID.
  • The drug exhibits a low incidence of gastrointestinal ulcers.
  • Adverse events were generally infrequent and not dose-dependent.

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