CELEBREX

Pharmacia/Pfizer's hailed breakthrough painkiller, Celebrex, launched in January 1999 as a pain relief drug for arthritis. Celebrex immediately overtook the previous Viagra record of highest number of scripts issued within the first 15 weeks with 3.2 million. But millions of prescriptions filled, and just three months on the market, reports linking Celebrex to 10 deaths and 11 cases of gastrointestinal hemorrhages surfaced, according to the FDA, leaving many concerned over the safety of the deemed "super aspirin".

April 6, 2000, the FDA wrote a letter concerned with Pharmacia's Celebrex and its promotional advertisements that misrepresented the safety of the drug. This letter came despite the prior FDA warning regarding the same advertisements. Cardiovascular problems, as well as kidney and liver damage, ulcers, and even death, have been linked to this controversial drug. The FDA stated its concern over the misrepresentation of safety information, the unsubstantiated comparative claims, the lack of fair balance, and the misrepresentation of efficacy information.

The annual rates of heart attack in both the Celebrex (celecoxib) and Vioxx (rofecoxib) studies were increased compared to a review of studies containing a total of more than 48,000 patients. In those studies, 0.52% of patients taking an inactive placebo pill had a heart attack each year. The annual rate of heart attack was 0.74% for patients taking rofecoxib and 0.80% for those taking celecoxib. The researches believe that until more research is done, doctors should use caution in prescribing Vioxx and Celebrex to patients with heart disease.