WASHINGTON — Novartis failed to give the government prompt, accurate reports about the deaths of dogs treated with a painkiller in the same class of medicines now linked to heart problems in humans, U.S. regulators have charged in a letter.
The problems with submissions involving the pain drug Deramaxx were among several violations of reporting require- ments for Novartis' animal drugs, the Food and Drug Administration said in the warning letter to the company.
Deramaxx is approved for relieving arthritis and post-surgical pain in dogs. Similar drugs for people are under scrutiny after studies associated them with heart attacks and strokes. One of the drugs, Merck's Vioxx, was pulled from the market.
Joseph Burkett, a spokesman for Novartis Animal Health Services, said the cardiovascular problems linked to such drugs for people were "not an issue" for dogs, because canine hearts are different from those of humans.