New Studies May Speed Recall of Celebrex

Two studies published this week in 'Circulation', the journal of the American Heart Association may speed the recall of the COX-2 painkiller Celebrex.

Dr. Garret FitzGerald of the University of Pennsylvania School of Medicine and colleagues used a statistical approach called meta-analysis to combine the findings of two trials to estimate the risk of heart attack and stroke in people taking Bextra. The results of this analysis suggests Bextra tripled the combined incidence of heart attack and stroke in heart bypass surgery patients.

In the second study, the researchers studied mice genetically prone to hardening of the arteries or atherosclerosis and found that a compound called thromboxane or TxA2, produced by COX-1, accelerates atherosclerosis.

“This is of particular interest, as low-dose aspirin prevents heart attack and stroke by blocking COX-1 formation of TxA2 in blood cells called platelets,” FitzGerald said in a statement.

When a COX-2 inhibitor was added, something happened that may help explain why the COX-2 inhibitors raise the risk of a heart attack, said FitzGerald’s colleague, Karine Egan.

“Addition of the COX-2 inhibitor caused changes that, if they occurred in humans, would result in a loss of stability of the plaque, making it more likely to rupture and activate clotting, causing heart attack or stroke,” she said.

“These results would have disturbing implications for patients at high cardiovascular risk treated with aspirin and a coxib (COX-2 inhibitor),” FitzGerald said.

Are these studies conclusive? Will they force the recall of Celebrex or Bextra? Only time will tell but you can be sure these studies will be discussed at next months FDA enquiry.