FDA rejects Arcoxia, Merck’s Vioxx successor

? The Food and Drug Administration rejected Merck & Co.’s request to market a successor to its withdrawn arthritis drug Vioxx in the United States, the drugmaker said Friday.

The decision was widely expected, after a panel of FDA advisers two weeks ago voted 20-1 against approving the drug, Arcoxia.

Arcoxia is in the class of anti-inflammatory drugs called Cox-2 inhibitors, which are touted as less likely to cause stomach bleeding or have other dangers, but they have been linked to heart risks. It is the same class of drugs as Vioxx, which has become a poster child for drug safety problems.

Merck pulled Vioxx from the market in September 2004 after research showed it doubled risk of heart attacks and strokes. That triggered an avalanche of lawsuits – more than 27,000 so far – and a nosedive for Merck’s stock price, which has since rebounded.