Celebrex Side Effects May Link To Heart Attack Lawsuits. Celebrex (Generic: Celecoxib) is a COX-2 inhibitor, a class of drugs linked to an increased risk of blood clots, heart attacks and strokes. Celebrex is the only COX-2 inhibitor still on the market in the United States. Celebrex and the recently withdrawn Bextra are both marketed by the Pharmacia Corporation and Pfizer Inc. in the United States. Celebrex and the other COX-2 inhibitors are prescribed for the treatment of osteoarthritis, adult rheumatoid arthritis, and the pain associated with menstrual cramping.
FDA Asked To Examine The COX-2
In February 2005, the FDA asked advisory committees to examine the COX-2 inhibitors and to determine whether they offer enough benefits to stay on the market, whether they need stronger warnings, and what further research on the drugs is needed. The advisers met from February 16, 2005 through February 18, 2005. Studies strongly suggest the entire class of drugs called COX-2 inhibitors elevates the chances of cardiovascular problems, Dr. Ned Braunstein, senior director of Merck Research Laboratories told the panel of FDA advisers.The hearings concluded and both Celebrex and Bextra were allowed to stay on the market. However, on April 7 the FDA asked Pfizer to withdraw Bextra from the market, citing reports of cardiovascular events and allergic skin reactions. When Pfizer agreed to suspend sales of Bextra, Celebrex became the last COX-2 inhibitor to remain on the market.
A study from the Cleveland Clinic appeared in the Journal of the American Medical Association and was based on an analysis of previous clinical trials. In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib (Vioxx) with the traditional NSAID naproxen, the risk of cardiovascular problems, including heart attack, chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib group than in the naproxen group. Merck voluntarily withdrew Vioxx in September 2004 after a study found that the drug doubled the risk of heart attack and stroke in patients who took it for at least 18 months. Following the Vioxx recall, questions arose about Celebrex, Bextra, and non-prescription pain relievers such as Naproxen (Aleve).
Celebrex may increase risk of heart attacks and lead to strokes
Dr. Garret Fitzgerald, a top scientist and COX-2 researcher at the University of Pennsylvania, told the US regulatory panel that all pain drugs in the class known as COX-2 inhibitors increase the risk of heart attacks and strokes. Dr. Fitzgerald has said that the body reacts in the same way to drugs including Merck’s Vioxx and Pfizer’s Celebrex and Bextra. Dr. Fitzgerald said the drugs create an imbalance in the body’s cardiovascular system that leads to an increased risk of heart attacks and strokes.
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.
On March 1, 2006, a group of researchers in New Zealand said that a reanalysis of older studies conducted on Pfizer’s pain reliever Celebrex show the drug can raise the risk of suffering a heart attack. Researchers from New Zealand’s Medical Research Institute in Wellington said that the analysis, which used data from past Celebrex clinical trials, showed the drug could nearly double the risk of heart attack in patients, according to local reports.
The analysis utilized data from six studies on Celebrex involving 12,780 users. The results were published in the Journal of the Royal Society of Medicine.
Pfizer has said it expects 2006 sales of Celebrex to be in excess of $2 billion.