Pfizer's Bextra side effects are 'potentially' life-threatening: US FDA
Pfizer Inc.'s painkiller Bextra should be kept off the market due to its life-threatening side effects, according to the US FDA. The drug poses greater health risks than similar painkillers, like Pfizer's Celebrex and Merck & Co.'s withdrawn Vioxx.
Pfizer voluntarily suspended sales of Bextra last April 7 at the request of the US regulators as it was linked to a rare, fatal skin disorder and an elevated risk of heart attacks.
Pfizer officials in May said they hoped to resume selling the drug, also known as valdecoxib.
"In the absence of any demonstrated advantage over other (pain medications), the overall benefit versus risk profile for valdecoxib is unfavourable for marketing," the FDA staff members wrote in documents prepared for an advisory committee hearing this week.
Pfizer continues talks with the FDA about the Bextra application and seeks for ways to make Bextra available to patients who can potentially derive benefit from the medication, claim media reports.
Bextra was a part of a review of the FDA's monitoring of risks associated with pain medications at a meeting of government advisers on Friday in Gaithersburg, Maryland.