Federal investigators are pursuing information from Novartis AG’s U.S. unit regarding the marketing of certain products, including the controversial blood pressure medication Tekturna.
In the Swiss drug giant’s 2012 annual report, it was disclosed that a subpoena was received last year from U.S. Attorney’s Office for the Western District of Kentucky, seeking marketing documents, including any documents related to payments to healthcare providers.
While Novartis said it is cooperating with the investigation, the company did indicate that the investigation is “civil and criminal in nature.”
Once a drug is approved by the FDA, pharmaceutical companies are not allowed to market or promote the medication for other uses that are not specified on its drug application. While medications may be prescribed “off label” by physicians, it is illegal for the manufacturer to actively market the drug for such unapproved uses or offer doctors compensation in return for prescribing the drug off-label.
Novartis previously faced charges in 2010 involving the illegal marketing of Trileptal, its anti-epileptic drug. The drug company plead guilty and agreed to pay nearly half a billion dollars to settle the allegations that Novartis created marketing materials that promoted the drug for treatment of neuropathic pain and bipolar disease, neither of which were an approved use by the FDA.
Investigators also began an inquiry into the Novartis owned Alcon eye-care unit and is investigating the export of products to other countries that are subject to U.S. trade sanctions, including Iran. Alcon was acquired by Novartis in 2011.
The Fort Worth, Texas, based company said they are also cooperating with the investigation by the U.S. Attorney’s Office for the Northern District of Texas, which includes a grand jury subpoena for documents dating back to 2005. U.S. Sanctions ban the export of goods and services to Iran from the United States or by Americans. Some medications and medical devices may be exported with proper licensing.
Tekturna Adverse Events
Tekturna (aliskiren) was approved in 2007 to treat high blood pressure. A 2011 clinical trial of the drug was canceled after a number of diabetic subjects began suffering from a high number of strokes and kidney problems.
Novartis was testing the drug to determine its effectiveness in treating diabetic hypertension when it determined Tekturna increased the risk of non-fatal strokes and kidney problems. Other side effects included hypotension an hyperkalemia which may cause circulatory problems, such as low pulse and heart rate.
More recently, QuarterWatch, a report on adverse drug events submitted to the FDA, found an increase of hypersensitivity reactions linked to Tekturna reported by patients and doctors. The reports were primarily of angioedema, a sudden swelling of the face, lips, tongue or throat that can cause severe obstruction of the airways.
Sales for Tekturna decreased dramatically last year after Novartis canceled the diabetic hypertension clinical trial. Novartis was testing the drug to see if it could be useful in the treatment of hypertension by diabetics. Instead, the drug maker found that Tekturna may increase the risk of non-fatal strokes, kidney damage and other health risks.