FDA advisers back Celebrex for children despite risks
GAITHERSBURG, Md. -- Children as young as 2 who suffer from arthritis can be treated with Celebrex, but to ensure the painkiller doesn't put them at later risk for heart attacks, their health should be tracked for decades, a Food and Drug Administration advisory panel said yesterday.
The panel voted 15 to 1 to recommend expanded use of the Pfizer Inc. drug, even though eight members said the treatment can be toxic for children. Those who said Celebrex is safe did so begrudgingly, citing the short time it was studied in children and a flawed study design that Pfizer selected and the FDA approved.
The FDA does not have to follow its advisers' guidance, but often does so.
During the hearing, the panel struggled with how to implement long-term safety surveillance without placing barriers between patients and a drug that works for many.
Because children with juvenile rheumatoid arthritis could be prescribed Celebrex or other painkillers for years, Pfizer should establish a patient registry to track such health indicators as blood pressure and kidney function for as long as three decades, the panel said. Celebrex can raise blood pressure and potentially place children who take it at higher risk for suffering a heart attack decades later, advisers said.
Dr. Eric Holmboe criticized Pfizer's proposal to monitor side-effect reports that doctors routinely file with the FDA, saying such a voluntary reporting system would be a "very weak instrument" for tracking long-term health outcomes. A patient registry could pinpoint health problems earlier, Holmboe, a vice president of the American Board of Internal Medicine , said later in an interview.
Juvenile rheumatoid arthritis affects as many as 60,000 children in the United States. Doctors already prescribe Celebrex for some of them, a practice known as off-label use, but they prefer to prescribe pediatric drugs whose safety and efficacy has been confirmed in children.
The panel's lengthy discussion and concerns about Celebrex safety are unlikely to dampen enthusiasm for it as an arthritis drug for children, especially when other treatments fail, said Dr. Dennis Boulware , an Alabama rheumatologist .
"I think many people underestimate what patients with bad arthritis really are willing to risk in order to get better," Boulware said in an interview. "I still have people who want to get Vioxx."
Some panel members worried that the approval recommendation would cause use of the drug for other medical conditions to spike.
Celebrex was the first of a class of new-style painkillers, called cox-2 inhibitors, approved eight years ago, and it is the last one to remain on the market. The drugs were touted as relieving pain without the stomach distress associated with other treatments, but they have been plagued by safety concerns, including increased risk for heart attack and stroke.
Pfizer halted advertising for Celebrex in 2004 after Vioxx , a similar painkiller, was pulled from the market, but since early 2006 the company has spent $33.2 million advertising Celebrex to consumers, according to Nielsen Monitor-Plus .
Diedtra Henderson can be reached at dhenderson@globe.com. 