Pfizer yesterday saw additional warnings of cardiovascular and gastrointestinal risk slapped on its multi-billion dollar painkiller, Celebrex (celecoxib), as it also got the thumb’s up from the US Food and Drug Administration for a new label to treat ankylosing spondylitis, a form of arthritis affecting the spine. But the US giant is not alone, as the country’s drug regulator will also be requiring other painkillers and arthritis drugs to carry similar warnings – including older therapies such as ibuprofen and naproxen [[17/06/05a]].
Specifically, the label will state that Celebrex should be prescribed “at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.” This is in addition to a caution that it “may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal.”
This is the sixth indication for Celebrex in the USA, and the company will be hoping to stem declining sales after jitters following the withdrawal of its major rival from Merck & Co, Vioxx (rofecoxib), because of an increased risk of heart attack [[01/10/04a]]. During the second quarter, Celebrex sales slumped 45% to $401 million dollars [[21/07/05b]].