Novartis Drug Investigated After 11 Deaths

Novartis Drug Investigated After 11 Deaths
World

A multiple sclerosis drug made by industry giant Novartis is under investigation after at least 11 patients taking the medicine died.

The drug, Gilenya, was licensed last year in the European Union to treat patients with a severe type of multiple sclerosis.

The deaths raise concerns Gilenya could trigger heart problems after patients take their first dose, according to a statement issued Friday by the European Medicines Agency. The agency, which is now investigating the drug, said it isn’t clear if it caused the deaths.

One of the deaths was in the U.S., where a patient died within 24 hours of taking the first dose.

The European agency said it didn’t know where the other 10 deaths occurred, but that they were reported to its drug database, which monitors side effects from medicines in the European Union.

A spokeswoman at the U.S. Food and Drug Administration said it also is conducting a data analysis but has not made any definitive conclusions and does not know when its review will be complete.

More than 30,000 patients have taken Gilenya worldwide. The European Medicines Agency advised doctors to increase their monitoring of patients after the first dose of the medicine. The agency said the risk of a slow heart rate after the first dose of Gilenya was known when it was approved.

Novartis AG said it was advising doctors of new recommendations on using Gilenya. They include continuous heart monitoring during the first six hours after patients take their first dose and measuring their blood pressure and heart rate every hour. This new guidance applies only to patients taking their first dose, Novartis said in a statement.

The EU drug regulator hopes to finish its review of the drug by March.

Associated Press

Share Tweet
React
Like Us On Facebook
Like Us On Facebook

Preston Waters

Preston Waters is a thinker. He's not your traditional philosophical persona, however, as he leaves no topic untouched. Covering all the bases, from business to women, Preston Waters is the ultimate man's man for Gen-Y.

More In World

World Sean Levinson

Forget Raving, MDMA Is Helping War Veterans Cope With Their PTSD

Tony Macie is one of the many Iraq veterans who returned home with post traumatic stress disorder. Doctors gave him anti-depressants but, as usual, they were no use. Thankfully, Tony is very open-minded and had heard of alternative methods of combating PTSD being experimented on in the Multidisciplinary Association for Psychedelic Studies (MAPS). Those are […]

World Katie Gonzalez

This Anti-Bullying Commercial Means Well But Completely Misses The Mark

Er… this anti-bullying PSA might prove that sometimes, something that is well-intentioned can still fail to deliver. The commercial, produced on behalf of VH1 by advertising agency Del Campo Saatchi & Saatchi, attempts to show how bullying is bad, and the ways in which students can cope after they’ve been victimized by the school’s biggest […]

Also On Elite

Women

5 Ways Every Girl Can Feel Beautiful Whenever She Wants

Now that spring has sprung, it’s time to wake up, smell the flowers and feel good about ourselves. Winter glum is a force that plagues far too many and regaining self-esteem, along with a fresh, positive attitude, can require quite the concerted effort. But have no fear, below are five awesome ways to feel beautiful […]

Success

10 Defining Traits That Have Made People Successful Throughout History

So what exactly is the recipe to make you successful? It’s difficult to conclusively define what makes any one individual achieve greatness, but there are certain general qualities that these people share. These are my top 10 traits that I believe all successful people have. Resilience This is a generous life. One that is full […]