...last year a US unit of the company received a subpoena from federal prosecutors in Louisville, Kentucky requesting documents on sales practice; this includes payments to healthcare providers for the drug and other medicinal products.
(PRWEB) January 29, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs, is weighing-in on a Bloomberg article reportingthat Novartis is under investigation for its marketing of Tekturna (aliskiren), a high blood pressure medication. According to Bloomberg News, last year a US unit of the company received a subpoena from federal prosecutors in Louisville, Kentucky requesting documents on sales practice; this includes payments to healthcare providers for the drug and other medicinal products.
Tekturna was approved in the US in 2007. Outside of the United States, the drug is sold under the brand name Rasilez. Tekturna raised safety concerns when Novartis halted clinical trials of the drug in December 2011. The ALTITUDE trials were conducted to see whether or not Tekturna would prevent cardiovascular and kidney problems in patients with diabetes. Instead, Novartis stopped the studies after a review committee d found that the patients taking Tekturna had a higher rate of complications, including:
- Non-fatal stroke
- Kidney problems/ complications
- Hyperkalemia (high potassium)
- Hypotension (low blood pressure)
Bloomberg reports that sale expectations for Tekturna were halved last year after the trials were stopped. The company recently reported that revenue from the drug decreased 31 percent to $383 million in 2012.
Late last year, the Institute for Safe Medication Practices (ISMP) released a report focused on the increasing number of adverse events associated with four “suspect” drugs, including Tekturna. Using the FDA’s adverse event report database, the public safety group found that in the first quarter of 2012 alone there were 100 reports of complications associated with Tekturna. The most prominent side effect was angioedema, a rapid swelling that typically affects the face, tongue, lips or throat. ISMP’s report stated that this event “can occur at any time during treatment and may be life threatening if the airway is obstructed.”
Last April, the U.S. Food and Drug Administration (FDA) updated the label on Tekturna to warn against using the drug with other hypertension medications, specifically ACE inhibitors and ARBs, among patients with kidney impairment or diabetes.
Parker Waichman LLLP offers free legal consultations to victims of Tekturna side effects. If you or a loved one suffered a stroke, heart attack, kidney problem or other side effect while taking Tekturna or Valturna, please contact their office by visiting the firm's Tekturna Injury page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney