As you have heard, Pfizer disclosed a connection between Celebrex and major heart problems:
The studies were conducted for Pfizer by the National Cancer Institute. In one [the APC cancer trial -ed], patients taking 400 mg to 800 milligrams of the drug daily were found to have a risk of experiencing major heart problems that was 2.5 times greater than people who were not taking the drug. The other cancer study [the PreSAP cancer trial -ed] found no increased heart risk with patients taking 400 mg. of Celebrex per day.
The first point that jumps out is that the typical dose of Celebrex is less than 400mg per day – and there is no data suggesting an increased risk of heart problems in these lower doses. Here is the recommended dosing schedule:
Osteoarthritis: Oral: 200 mg/day as a single dose or in divided dose twice dailyRheumatoid arthritis: Oral: 100-200 mg twice daily
Familial adenomatous polyposis (FAP): Oral: 400 mg twice daily
Acute pain or primary dysmenorrhea: Oral: Initial dose: 400 mg, followed by an additional 200 mg if needed on day 1; maintenance dose: 200 mg twice daily as needed
Thus, only in uncommon cases (i.e. FAP) should more than 400mg per day be used. Again, the studies did not show an increased risk of heart problems in the common, usual doses.
Pfizer is analyzing the information and debating what to do. Currently, they have no plans to withdraw Celebrex from the market.
Pfizer is already under fire from Bextra, another COX-2, which recently received a black box warning as well as a suggestion of increased cardiac risk in very high-risk patients. A fast-track letter to the NEJM recommends that it too should be pulled.
With Pfizer taking an aggressive stance in its defense of Celebrex, the lawyers are salivating at a potential lawsuit boon:
Pfizer is not, however, following in Merck’s footsteps by yanking the drug from the market. At least one attorney, who is representing thousands of Vioxx plaintiffs, believes the company should. William Federman, a class-action attorney in Oklahoma City, called Pfizer’s position an “aggressive” one that could bring legal risks.
Again, I can point to direct-to-consumer marketing as a culprit fueling this fire:
Many, including Dollarhide, believe that heavy promotion drove consumers to ask their doctors for the drugs by name and, therefore, fuel their popularity. But Dollarhide now wonders whether doctors will be as willing to write prescriptions for COX-2 inhibitors — even if they do stay on the market.
So, what to do? Until this sorts itself out, I would be wary of the whole class of medication. The option of COX-2 preferential drugs as well as an NSAID/proton pump inhibitor combination are alternatives for those who need COX-2 medications.
Medpundit and Medrants give their opinions on the situation.
