Pfizer Inc. said Monday the Food and Drug Administration added some warnings to the label of its Celebrex pain reliever developed by Monsanto Co.
Pfizer said the label contains a warning of potential cardiovascular and gastrointestinal risks. The label also recommends that Celebrex be prescribed at the lowest effective dose for the shortest period of time.
In February, the FDA recommended that stronger warnings be given to the COX-2 pain relievers, such as Celebrex, as well as to non-steroidal anti-inflammatory drugs, such as ibuprofen and naproxen.
Monsanto’s (NYSE: MON) G.D. Searle & Co. pharmaceutical unit rolled out Celebrex in February 1999. In December 2004, Pfizer said Celebrex could increase the risk of heart problems. It later pulled advertising for the drug and pulled another of its pain relievers, Bextra, from the market.
In 2004, Celebrex sales totaled $3.3 billion and Bextra sales totaled $1.3 billion, according to published reports.
The FDA also approved the drug to treat a sixth condition, ankylosing spondylitis, which affects more than 400,000 Americans.