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US FDA: Novartis Late With Dog Painkiller Reports

Tuesday, December 28, 2004

WASHINGTON (Reuters) - Novartis AG failed to give the government prompt, accurate reports about 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 requirements for Novartis animal drugs, the Food and Drug Administration said.

Deramaxx is a COX-2 inhibitor approved for relieving arthritis and post-surgical pain in dogs.

Similar drugs for people are under heavy scrutiny after studies associated them with heart attacks and strokes. One of the drugs, Merck & Co Inc.'s Vioxx, was pulled from the market because of safety risks.

Death has been reported "in rare situations" when dogs were treated with Deramaxx, according to the drug's label instructions.

Joseph Burkett, a spokesman for Novartis Animal Health Services, said the cardiovascular problems linked to COX-2 drugs for people were "not an issue" for dogs, as canine hearts have different physiology from those of humans.

"The findings on COX-2s (for people) are absolutely unrelated to" Deramaxx use in dogs, he said.

The FDA, in a warning letter dated Nov. 29, said a January 2004 inspection at a Novartis animal health facility in North Carolina found "significant deviations from adverse drug experience reporting requirements."

Novartis should have forwarded complaints about deaths and health problems in dogs given Deramaxx and other drugs within 15 working days, but in some cases delayed as long as 10 months, the FDA said. Some reports, including ones involving deaths, appeared to have incorrect dates, the FDA said.

"Novartis failed to submit timely and accurate information to the FDA regarding serious (adverse drug experiences) associated with the administration of its FDA-approved animal drug product Deramaxx ... during its first year of marketing," the FDA said.

Deramaxx is known generically as deracoxib.

Novartis started correcting problems immediately after the January inspection and has given the FDA a detailed response to the letter, Burkett said. "We have changed our internal processes to match the expectations of the FDA," he said.

The FDA sends dozens of warning letters per year. Most of the issues raised are resolved without further regulatory action, although the letters sometimes lead to tougher steps such as product seizures.

The warning letter to Novartis is posted on the FDA Web site at http://www.fda.gov/foi/warning_letters/g5108d.pdf

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