Novartis has another ticking time bomb on its hand, with an MS drug that has caused more than 11 people to die, according to Novartis sales reps. Gilenya (fingolimod) is used to prevent episodes of symptoms and slow the worsening of disability in patients with relapsing forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Fingolimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.
Based upon my sources, the sales reps are not happy with the way the company is handling the side effects of this drug. Doctors are getting nervous about it too.
In reality, it is amazing that this drug ever made it on to the market. According to this study, there were 84 deaths during the clinical trials. http://www.ema.europa.eu/docs/en_GB/...C500104529.pdf Wow! Something tells me that this drug may end up being recalled.
The deaths of the patients have led regulators to be concerned that Gilenya may trigger heart problems, especially after patients have taken their first dose. One patient reportedly died within 24 hours of taking the drug. In November 2011, a patient died in the USA in an event that may have been related to the drug or for other reasons. This remains the subject of an FDA investigation.
The investigation into the ill-health effects and into Novartis is being undertaken by the European Medicines Agency (EMA), which has similar status to the U.S. Food and Drug Administration (FDA). The EMA is expected to conclude its investigation in March. In addition to the European concerns, Fox News have reported that the FDA are also conducting their own data analysis and will make an announcement about the use of Gilenya in the near future.
