European drug maker Novartis is under investigation by U.S. prosecutors for its marketing practices, including the marketing of the hypertension drug Tekturna.
In recent regulatory filings, Swiss-based Novartis revealed that, in 2012, a U.S. division of the company received a subpoena from federal prosecutors in Louisville, Kentucky, seeking documents on sales practices, including payments to health-care providers, for Tekturna and other medicines, Bloomberg.com reported.
Tekturna (aliskiren), a blood pressure medication that’s been on the market since 2007, works by reducing the body’s production of the enzyme renin, which has been shown to increase blood pressure. But an independent watchdog group, the Institute for Safe Medical Practices (ISMP), noted a serious hypersensitivity reaction among Tekturna users. Angioedema—a sudden swelling of the tongue, face, lips, or throat—could be life-threatening if the swelling blocks the patient’s airway. The ISMP’s examination of adverse events reports to the U.S. Food and Drug Administration (FDA) showed that Tekturna is among the top four medications cited in reports to the agency over the last four years. European and Canadian regulatory agencies are also reviewing Tekturna’s safety and effectiveness; the drug is sold there under the brand name Rasilez.
Bloomberg.com reports that sales projections for Tekturna dropped sharply after Novartis halted a multinational clinical trial of the drug. More than 8,500 Type 2 diabetes patients from 36 countries were involved in the trial. A higher-than-expected incidence of adverse reactions, including nonfatal strokes and renal complications, prompted Novartis to stop the trial. The $383 million in revenues from Tekturna in 2012 represent a 31 percent decline from previous revenues.
Novartis also disclosed an investigation of its interactions with specialty pharmaceuticals companies involving cancer drug Gleevec and Gilenya, a multiple sclerosis medication. In addition, U.S. prosecutors are investigating the Alcon eye-care unit over the export of products to Iran and other countries subject to trade sanctions. Bloomberg.com said that Novartis reports it is cooperating with all the investigations.