Celebrex: Is It Really Safe?
2 CommentsBy Ed Silverman // February 25th, 2007 // 10:41 am
There were numerous and troubling side-effect reports filed with the FDA about Pfizer’s painkiller after a widely publicized panel meeting was held in early 2005 to review the drug.
Nearly 300 blamed a patient’s death on the pill. More than half coming after a cardiovascular event, such as a heart attack, according to a review of the reports by The Boston Globe. But what does this really mean?
“I’m not sure we can really make much of that data,” says Scott Solomon, who directs non-invasive cardiology at Brigham and Women’s Hospital in Boston, and believes media coverage at the time spurred more people to file reports with the FDA than might have otherwise.
But Curt Furberg, a drug-safety expert at Wake Forest University School of Medicine, reminds us that the number of side-effect reports filed are usually only a fraction of actual adverse events, since as few as 10 percent of doctors bother to fill out the paperwork.
Of course, lawsuits have been filed against Pfizer, even as prescriptions are still written for the painkiller. At the same time, Pfizer continues to study the drug. All of which leaves unresolved the extent to which the drug is safe - at least for some people - and what, if anything further, the FDA should do.
[tags]Celebrex, Pfizer[/tags]
MS
The Boston Globe article is a joke. It does not provide any new information and merely adds to the hype and anxiousness around Cox-2s. It quotes someone who claims that they were healthy their entire life and implies that their unfortunate stroke was indeed caused by Celebrex. Did the Boston Globe reporter actually review this person’s annual medical records to reasonably test their health claims? Seems to me that the writer is quoting a few sad anecdotal events to pull at readers heart strings rather than to make any objective sort of claim on Celebrex.
I do think there are probably increased CV risks with Cox-2 drugs but so probably is the case with naproxen and others. There is a cost-benefit case to be looked at. If I have to trade off my ability to get up from bed (thanks to Celebrex) vs a small chance of increased stroke risk in 5yrs, I might opt for the former. Where the pharma companies erred was in the DTC ads making it sound like these were really safe - this issue has been addressed by the FDA’s black box warning for this class of drugs.
ed
Hi MS,
You raise some valid questions. Is this really a new issue or a rehash? It’s not new, no, but it remains alive. If it weren’t, Pfizer wouldn’t have to continue studying the drug. In that regard, the Black Box isn’t necessarily the last word.
I think the larger point the story tried to get at was the issue of ongoing uncertainty over a drug that’s in a troubled class of medicines. That was the key reason I thought to highlight the piece.
I’m sure you realize that I don’t know if the reporter reviewed an individual’s medical records. In my exerience, that’s now very unsual due to privacy laws over health info. So I tend to doubt it.
ed