PFIZER called for an immediate review of older painkillers last night after the European Medicines Agency (EMEA) ordered a ban on the sale of next-generation medicines, known collectively as Cox-2 inhibitors, among patients with heart problems.
Mitchell Gandelman, a senior scientist at the US drugs giant, demanded that older drugs, typically known as non-steroidal anti-inflammatory drugs (NSAID), be placed under the same scrutiny as Cox-2s, such as the company’s own medicines, Celebrex and Bextra.
“It is important that people understand the risks in some of the older competitors that are on the market,” he said.
Cox-2s were initially seen as a great step forward from NSAIDs, which can cause stomach bleeding in some patients. Heart problems associated with the class surfaced after drugmakers began testing their Cox-2s for long-term use among cancer patients. While the new generation of painkillers has since faced intense scrutiny, Dr Gandelman said that there have never been trials to determine whether NSAIDs might also excacerbate heart problems. “Just because they are older does not mean they are safer. Cox-2 inhibitors have been made to answer questions that other drugs have so far avoided.”
Dr Gandelman was speaking as a panel of scientists at the EMEA accepted that the whole class of Cox-2 drugs could exacerbate heart problems among patients. Previously Pfizer had argued that Celebrex and Bextra worked in a different way to that of Vioxx, Merck’s arthritis painkiller, which was pulled from the market last September amid safety fears.
Advertisement
In a statement the EMEA said: “The CHMP (Committee for Medicinal Products for Human Use) concluded that the available data show an increased risk of cardiovascular adverse events for Cox-2 inhibitors as a class. The data also suggest an association between duration and dose of intake and the probability of suffering a cardiovascular event.”
The agency stopped short of banning the class of drug entirely, allowing Pfizer to continue marketing Celebrex and Bextra in Europe. But in addition to halting the sale of Cox-2s to patients suffering heart problems or stroke, the regulator warned doctors not to prescribe them to patients with high cholesterol, diabetes, or to those who smoke. The EMEA also specifically banned the use of Arcoxia, a new version of Merck’s Vioxx, among patients with high blood pressure.
The agency added: “Given the association between cardiovascular risk and exposure to Cox-2 inhibitors, doctors are advised to use the lowest effective dose over the shortest possible duration of treatment.”
The EMEA said that its review of all Cox-2s would continue and that it would make a further announcement in April.
Its findings support data presented by David Graham, a safety expert from within the US Food and Drug Administration, who has argued that all drugs in the Cox-2 class can trigger increased risk of heart attack.