How Celecoxib Could Be Safer, How Valdecoxib Might Have Been

Abstract

Following the actions of the Food and Drug Administration (FDA) in April 2005, celecoxib became the only generally available cyclooxygenase-2 inhibiting antiinflammatory drug. The FDA instituted new precautions regarding the use of celecoxib and encouraged the use of “the lowest effective dose.” This dose, as defined by the FDA and the package insert, is 200 mg/day for all patients; 200 mg/day of celecoxib is a strong dosage, equivalent to naproxen 500 mg twice daily. However, many patients receiving naproxen benefit from much lower, safer dosages. With celecoxib, studies have shown that a 50% lower dosage is effective and causes fewer adverse effects. Because nonsteroidal antiinflammatory drug–related events involving the gastrointestinal, renal, and cardiovascular systems are dose-related, it is essential to define the very lowest effective dosages of celecoxib and to make these dosages available for use. This article discusses the increasing trend of drug companies to market new drugs with one-size-fits-all or limited dosages, thereby making it difficult or impossible to individualize treatment based on patients' age, size, state of health, or use of concomitant medications. Imagine if naproxen had been marketed only at 500 mg twice daily or ibuprofen at 800 mg 4 times daily. Flexible, individualized dosing is required to provide optimal therapeutics. If celecoxib and valdecoxib had been marketed with a range of doses, many serious adverse effects might have been avoided. The marketing of strong, one-size-fits-all dosages places patients, physicians, and even manufacturers at unnecessary risk of unwanted events.