Arthritis News – 1999

On 4/20/99, The Wall Street Journal reported that celecoxib (Celebrex) has been linked to 10 deaths and 11 cases of gastrointestinal hemorrhages. Five (four men age 45-88 and one woman age 75) of the 10 who died suffered from gastrointestinal bleeding or ulcers. Two deaths were attributed to heart attacks, one to drug interaction and one to kidney disorder. No cause of death was noted in one case.

In an interview, a Food and Drug Administration (FDA) official found it difficult to evaluate the significance of these reports in light of the high number of individuals currently taking Celebrex. Celebrex has been on the market for 13 weeks, and 2.5 million prescriptions have already been dispensed. Robert DeLap, director of the FDA office of drug evaluation, stated that more research is necessary before reaching any conclusions. However, he does not think that Celebrex poses any special risk at this time.

Editorial comment: The case reports of deaths from gastrointestinal hemorrhage in patients on Celebrex are worth noting, but the significance of these findings is unclear. Celebrex has been shown to have a lower GI toxicity profile based on short-term endoscopic studies showing less ulcers and gastric irritation compared to other NSAIDs. However, long term studies of the incidence of clinically significant GI bleeding are still forthcoming. These current reports may point out that Celebrex, while significantly safer that other NSAIDs, will continue to have some GI toxicity. It should be noted that these reports are extremely small in number in comparison to the large number of prescriptions written. Many of these prescriptions are undoubtedly written for patients with a greater risk of GI bleeding, such as the elderly, patients with prior ulcer disease or patients on anticoagulants. Practitioners should continue to use Celebrex with caution in patients with significant risk of GI bleeding.