Bextra likely to get ‘black box,’as study shows heart risk
"black box" designation, results of a study have surfaced showing the incidence of heart attack and stroke for those taking the drug was nearly double of those given placebos.
The results of the study, conducted by the University of Pennsylvania, were presented at a meeting of the American Heart Association on Nov. 9 and first reported in the New
York Times the following day. In a company statement, Pfizer
said the story drew unsubstantiated conclusions about the cardiovascular safety of COX-2 drug Bextra and is
based on information that has not been published in a medical journal or subject to independent scientific review.
The FDA plans to convene an advisory committee in February
2005 to review the cardiovascular safety of all COX-2 inhibitors. "We
look forward to a scientific and reasoned evaluation in this appropriate setting," said Joseph Feczko, Pfizer's president of worldwide development. News of the study results spread as
around the same time as Pfizer told investors it expected "black box"
status for Bextra after learning the drug can cause Stevens-Johnson
Syndrome, a rare but life threatening drug reaction in which the skin,
mouth and eyes can become blistered.
The risk exists primarily within the first two weeks of therapy and
is much more common with Bextra than other COX-2 inhibitors, such as Celebrex.