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Safety of Novartis' MS drug Gilenya reviewed after 11 deaths

EMA review of cardiovascular effects of drug follows FDA reassessment

The EMA has started a safety review of Novartis' multiple sclerosis treatment Gilenya (fingolimod) after 11 deaths among patients taking the drug.

The US FDA started its own review of Gilenya last month, after a patient died within 24 hours of taking the first dose of the oral medication. That prompted Novartis to release new phase III trial results supporting the safety profile of the drug.

The EMA said in a statement that there are concerns about the effect of the medicine on the heart after first exposure.

Of the eleven deaths among patients receiving Gilenya treatment,  seven are unexplained, three are due to heart attack and one was caused by disruption to the heart rhythm.

The drug was approved in Europe in March 2011 and is also on the market in the US and Japan and around 50 other countries worldwide. To date it has been used in around 30,000 patients worldwide.

It has been taken up fairly rapidly among MS patients as an oral alternative to injectable therapy with beta interferon, adding $291m in revenues by the end of September 2011.

Gilenya is known to cause a slowing of the heart rate or bradycardia, particularly in patients who are also receiving cardiac medication such as beta blockers and calcium channel blockers.

The patient who died in the US was known to be taking drugs in both these classes, namely metoprolol and amlodipine.

While the review is ongoing, the EMA is advising doctors to increase their level of monitoring of patients after the first dose of the medicine, particularly by carrying out electrocardiograms before treatment with Gilenya and for six hours thereafter.

Patients should also have their blood pressure and heart rate checked every hour, it said.

Anyone exhibiting signs of bradycardia or a condition affecting the electrical conductivity of the heart known as atrioventricular block should continue to be supervised until their condition has improved.

The agency said it expects to complete its review before a forthcoming plenary meeting in March.

23rd January 2012

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