This article is part of the Arthritis Archives.
Dateline: May 9, 1999
Celebrex Rebounds After Report
News about Celebrex (celecoxib) in the Wall Street Journal on April 20, 1999 left readers confused, concerned, and cautious. Follow-up investigation and reports have revealed details that indicate the concern was overblown.
The original report (See: Celebrex Causes Concern) linked the COX-2 selective inhibitor Celebrex (generic drug name celecoxib made by Monsanto Searle) to 10 deaths and 11 cases of gastrointestinal hemorrhage.
The news caused an abrupt decline in sales of Celebrex, the popular arthritis drug which has been recognized as one of the best-selling new pharmaceuticals ever. Prescriptions for Celebrex fell approximately 15% because of the adverse news.
- For the week ending April 30,1999, total Celebrex prescriptions fell to 325,862 from 329,989 the week before and from a peak of 361,081 for the week ending April 16, 1999.
- Also for the week ending April 30,1999, new prescriptions numbered 207,498 down from 222,954 the previous week and a peak of 259,119.
Follow-Up Article Contradicts Original Report
On April 28, 1999, the Wall Street Journal published a follow-up article with further analysis which contradicted the original report. The follow-up article disclosed that several doctors who evaluated the negative report on Celebrex felt there was no reason to establish a direct link between the deaths and the drug. Among the population of people taking Celebrex a certain number of deaths and ulcers is expected. Some doctors reportedly found the number of adverse events to be lower than what is expected.
One doctor suggested that the negative report about Celebrex should be compared to what is known about older NSAIDs (nonsteroidal anti-inflammatory drugs). The older NSAIDs cause one bleeding ulcer for 100 people taking the drug for one year. Comparatively, for the same number of people and same time period as Celebrex was used, 821 bleeding ulcers and 123 deaths would have been expected from an older NSAID.
Of the five people who died and had gastrointestinal bleeds in the original Wall Street Journal report, included were:
- a 77-year old woman, hospitalized in the previous 30 days for GI bleeding, may not have taken Celebrex.
- an 84-year old man who suffered GI bleeding before taking Celebrex and also had a heart attack.
- a 46-year old man with history of liver failure, alcoholism, and was taking another NSAID along with Celebrex.
- a 75-year old woman who likely died of an aneurysm in the abdomen and had taken Celebrex for only 3 days.
The expounded information has resulted in renewed confidence regarding the safety of Celebrex for the treatment of arthritis and in rebounding sales. That's good news for Monsanto Searle and for a multitude of arthritis patients who have pinned their hopes to the very popular arthritis drug since it was first marketed in January 1999.
Monsanto's Celebrex Sales Down Sharply On Recent Reports, Wall Street Journal, April 28, 1999.
Searle's Celebrex Prescriptions Rebound, Reuters, May 6, 1999.
Searle Responds To Journal Report On Celebrex Side Effects, April 22, 1999.
First published: 05/09/1999