US Warns Novartis Over Hypertension Drug Promotion

Promotional material for Novartis AG’s hypertension drug Diovan contain unapproved claims that it helps diabetics maintain proper kidney function, according to a regulatory letter released on Thursday.

Promotional material for Novartis AG’s hypertension drug Diovan contain unapproved claims that it helps diabetics maintain proper kidney function, according to a regulatory letter released on Thursday The U.S. Food and Drug Administration said Novartis distributed sales aids stating the drug could ease symptoms of kidney problems known as diabetic nephropathy. The study cited in the material shows no clinical benefits, the FDA said. “Diovan has not been shown to be effective in the treatment of any condition related to diabetes,” the letter said. The agency said Novartis has made similar claims in past promotions, including a 1999 brochure stating Diovan aided congestive heart failure and other conditions. “The sales aid, like other promotional materials Novartis has disseminated in the past, encourages use of Diovan in conditions for which the FDA has not reviewed safety and effectiveness data,” the letter said. The letter, dated April 21, was posted on the agency’s Web site Thursday at http://www.fda.gov/cder/warn/2004/11949Zyrtec-D.pdf. Novartis must stop circulating the Diovan materials and make plans to redistribute accurate information to those who have already received it, the FDA said. Anna Frable, spokeswoman for the Swiss drug maker, said the company was reviewing the letter and would respond to the FDA by the May 5 deadline. “We did receive the letter, and we take it seriously,” she said. The FDA sends dozens of warning letters each year. In most cases, the issues raised are resolved without further regulatory action. If the violations cited are not corrected, the FDA can seek a seizure, injunction or other penalty. (Source: Reuters Health News: May 2004)