BLACK-BOX WARNING ADDED TO CELEBREX LABELING

The FDA has approved a new black-box warning for Pfizer's arthritis pain drug Celebrex that highlights the increased risk of cardiovascular (CV) events associated with the product.

The drug also received a new indication for the relief of the signs and symptoms associated with ankylosing spondylitis, a form of arthritis that affects the spine, Pfizer said.

Celebrex (celecoxib), a Cox-2 inhibitor drug, has been the subject of intense agency and public scrutiny following last fall's sudden withdrawal of Merck's Cox-2 product Vioxx (rofecoxib), which had been linked to elevated risks of heart attacks and strokes.

An FDA advisory panel of arthritis and drug-safety experts unanimously agreed in February that Celebrex, Vioxx and Pfizer's other Cox-2 drug Bextra (valdecoxib) significantly increased the risk of CV events. In April, the FDA announced labeling changes for the entire nonsteroidal anti-inflammatory drug (NSAID) class, of which Cox-2s are a member.

As part of the agency's order, Pfizer was required to add a black-box warning stating the potential for increased risk of CV events and life-threatening gastrointestinal bleeding. The FDA also asked Pfizer to include a medication guide as part of Celebrex's labeling. In addition, Pfizer agreed to conduct a long-term study comparing the safety of Celebrex to naproxen and other appropriate drugs.

The focus on Celebrex's safety problems has taken its toll on the drug's bottom line. The drug generated revenues of $401 million in the second quarter of 2005, down 45 percent from the $728 million it generated in the same period last year.