U.S. prosecutors are investigating European drug manufacturer Novartis for its marketing of products including hypertension drug Tekturna.
In a recent regulatory filing, Swiss-based Novartis revealed that, last year, a U.S. unit 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 medication launched in 2007 for the treatment of high blood pressure, reduces the body’s production of the enzyme renin, which has been shown to increase blood pressure. But, as we’ve previously written, the Institute for Safe Medical Practices (ISMP), an independent watchdog group, observed 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 airway. The ISMP reported that Tekturna is among the top four medications cited in adverse effects reports to the U.S. Food and Drug Administration (FDA) over the last four years.
Sales expectations for Tekturna plummeted, Bloomberg.com said, after Novartis halted a multinational clinical trial over unexpected adverse reactions among the more than 8,500 Type 2 diabetes patients in the trial. The $383 million in revenues from Tekturna in 2012 represent a 31 percent decline.
Novartis also reported investigations of its interactions with specialty pharmaceuticals involving its cancer medicine Gleevec and Gilenya, a multiple sclerosis medication, and the company disclosed that 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 is cooperating with all the investigations.