Worries are emerging about the safety of new diabetes medicines Januvia and Galvus, drugs expected to be big sellers for makers Merck and Novartis. But it is unclear if the concerns are justified or just the result of a hair-trigger tendency concerning drug safety on the part of doctors and regulators.
On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus. Analysts say that could take another year; the pill has already been delayed for three months.
That follows a Feb. 1 article in The New England Journal of Medicine that questioned the safety data available for these drugs. David M. Nathan, a Harvard Medical School endocrinologist, wrote that it is "surprising" that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan, who is a consultant for Novartis and other drug makers but not Merck , did not return requests for comment.