Novartis Drug Gilenya Leads to Government Investigations, Safety Concerns

novartis_gilenya_investigationsNovartis’ Gilenya, a drug used to treat multiple sclerosis, is under investigation over allegations that the company paid kickbacks to healthcare providers for using the medication. The probe isn’t the first for Novartis. In the past year, the company has faced scrutiny over Gilenya, as well as its blood pressure drug Tekturna.

This month, Novartis was served a civil investigation demand by US Attorney’s Office for the Southern District of New York over allegations of kickbacks to healthcare professionals over Gilenya, according to filing with the U.S. Securities and Exchange Commission. Among other things, the Attorney’s Office asked the company for documents about how it markets Gilenya and if it made any payments to healthcare providers for using it.

Novartis is already being investigated due to Gilenya; in a January SEC filing, the company stated that US attorneys for the Western District of Kentucky subpoenaed documents regarding how it marketed Tekturna, its hypertension drug. Tekturna raised health concerns when a study was stopped because patients were experiencing serious side effects, including non-fatal stroke, renal complications, hyperkalemia (high potassium) and hypotension (low blood pressure). The filing also showed that the Southern District of New York had been questioning the company its interactions with specialty pharmacies regarding Gilenya and Gleevec.

The U.S. Food and Drug Administration (FDA) started investigating Gilenya following reports one patient reportedly died 24 hours after taking the first dose. The FDA review revealed that other patients had also suffered adverse reactions, including some heart-related deaths. Last May the agency issued an official warning about the drug, stating that it should not be prescribed to patients who have a pre-existing heart condition. Doctors who do prescribe GIlenya were told to monitor them for six hours after the first dose. Now, overnight monitoring is also advised for patients who take certain medication or have a predisposition to heart conditions.

This entry was posted in Legal News. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.