Study: Low-Dose Celebrex Poses No Heart Risk
But FDA Scientist Says Older Painkillers Can Raise Risk of Heart Attacks
Maker of Celebrex Reacts continued...
Officials from Pfizer, which markets Celebrex, told the panel Wednesday that most studies do not show an increased heart risk with their drug and that safety concerns appear unique to Vioxx.
The results have left experts to figure out whether heart problems are unique to Vioxx or whether they apply to the other drugs in the Cox-2 family. Graham said his conclusions suggest that the whole class, which includes Bextra and two other drugs not available in the U.S., have increased risk.
"I believe based on the evidence that there is a Cox-2 effect and that the Cox-2 effect is dose-dependent," he said.
Several committee members expressed doubt about Graham's conclusions, noting that there were problems with his studies, including the possibility that other factors may have increased heart risk.
Ibuprofen and Heart Attacks
The California study also showed an increased risk of heart attack associated with several older anti-inflammatory drugs, including ibuprofen. That drug appeared to raise the users' risk of heart attack by 11%, an increased risk that Graham referred to as "small but significant" since tens of millions of Americans use the drug regularly.
Other NSAIDs, including indomethacin, a drug often used for gout, and Mobic, an increasingly popular drug since the Cox-2 drugs came under fire, also appeared to raise heart attack risk by 40% to 70%, according to the study.
Graham said the data suggest that researchers must take a closer look at older anti-inflammatory drugs to learn more about their possible safety concerns. Regulators should "weed the garden of bad actors," he said.
Early Vioxx Risks?
Merck scientists presented data Wednesday suggesting that heart risks with Vioxx do not show up until the patients have taken them for at least 18 months. The claim backed up Merck's decision to wait until September 2004 to remove Vioxx from the market because a major study had not yet shown a safety concern.
Graham contradicted those claims, showing a separate analysis in which Vioxx appeared to cause heart attacks much earlier in treatment. Several studies in the analysis show a 30% to 50% increased risk of heart attacks within the first 30 days of use.
Merck's study did not find the risk because the early heart attacks are relatively rare and difficult to detect. Risk of heart attack begins when use of Vioxx begins, says Graham.
Merck officials were not immediately available to comment on the study.