Merck researcher says all COX-2s may carry heart risk
All COX-2s may cause heart problems or strokes, a Merck researcher said during day one of the FDA's three-day joint session to gather safety data and make recommendations on the future of the drug class.
Ned Braunstein, senior director of Merck Research Laboratories, told two panels of FDA advisers that since his company pulled Vioxx from the market in September, studies suggesting similar problems with Celebrex and Bextra prompted him to come to the conclusion – a change in stance from Merck's earlier position that such health issues appeared to be limited to Vioxx.
"The data strongly suggest it is a class effect," Braunstein said.
Lourdes Villalba, an FDA medical officer responsible for Vioxx the agency's Center for Drug Evaluation and Research, told the panels there were preliminary indications of heart problems with Vioxx before it was withdrawn, but it was difficult to sort through conflicting data.
"We were not asleep at the wheel, we were actually engaged in reviewing a lot of data," Villaba told the joint meeting of the FDA's arthritis advisory committee and its drug safety and risk management advisory committee.
Villalba pointed out that a study done in 200 people comparing Vioxx with pain killer naproxen, showed a higher rate of heart problems with Vioxx, but other studies had conflicting results. In talks with Merck, she said, the company suggested naproxen might have a heart protective effect.
Nonetheless, in 2002 the FDA required an added warning on the Vioxx label urging caution in prescribing it for people with heart conditions.
The committees also explored the safety of Pfizer's COX-2s Celebrex and Bextra.
Pfizer vice president Joseph Feczko said the reports of increased heart problems in need to be seen in context, considering COX-2s bring a benefits of reducing stomach and intestinal problems that occur with other painkillers.
Kenneth Verberg, Pfizer vice president for inflammation and immunology, defended Celebrex as safe, despite clinical trial results linking it to increased heart risks.
There is little data on the use of Celebrex for more than a year and further long-term testing is needed, Verberg said.