, the Swiss manufacturer of the multiple sclerosis drug, is subjected to a European wide investigation after at least 11 patients taking the medicine died (as announced by several media outlets and by the Multiple Schlerosis Resource Center
). The drug which was taken goes under the brand name Gilenya
. The drug is relatively new and was only licensed last year in the European Union (the drug was approved for use in the USA in 2010).
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.
Neither agency is stating, at this stage, that Gilenya is the cause and the investigations are continuing. The announcement, according to the San Francisco Chronicle
, led to a steep fall in the Novartis share price. Gilenya is an expensive drug, with MS News
estimating that a year’s supply for a patient would cost $48,000.
Bloomberg Business Week
quotes from a statement from Novartis, which runs: “The role of Gilenya in the reported cardiovascular events has not been fully established and the cause of this patient’s death is still unexplained. Novartis continues to believe that Gilenya provides an important health benefit.”
In the meantime the drug has not been withdrawn. Gilenya is taken by some 30,000 patients worldwide. In light of the reported incidents the EMA has advised medical staff to increase the monitoring of patients. When the drug was released, medicines agencies were aware that there was a risk of slow heart rate, or bradycardia. The requirement for monitoring is also likely to become a recommendation in the product insert, which accompanies the medicine.
This recent situation follows on from further problems relating to Novartis. Earlier this year, the Digital Journal
reported on concerns about quality control at Novartis after powerful prescription pain drugs and common over-the-counter medications, like Excedrin and Gas-X, made at a Novartis manufacturing plant became mixed-up. A further Digital Journal
report also indicated that chipped and broken pills and inconsistent bottle packaging clearance practices had led to consumers potentially taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient.
These reports indicate that, despite twenty-first century technology, quality control errors can have serious consequences for patients and consumers of medicines.