FDA LABLE CHANGE
Novartis warns of heart risk related to its oral multiple sclerosis drug Gilenya.
22 April 12 11:49, Globes' correspondent
Novartis AG has added a warning on the US label of its oral multiple sclerosis drug, Gilenya, a competitor of Teva Pharmaceutical Industries Ltd's Copaxone, to help prevent heart problems.
The updated US label says that patients with some cardiac conditions, including heart attack or stroke in the last six months, should not take Gilenya. It says that all patients should have an electrocardiogram before they start using Gilenya, and that they should have a second scan six hours after the first dose of the drug in addition to hourly monitoring of blood pressure and heart rate. Those steps are also recommended for patients whose treatment has been interrupted.
The US label changes are the result of discussions with the US Food and Drug Administration (FDA) that began in December, following cases of heart attacks and strokes in patients who took Gilenya. Novartis is in talks with European Union regulators about other label changes, including warnings against using the drug in patients who are at risk of developing slow or abnormal heart rates.
Novartis warns of heart risk related to its oral multiple sclerosis drug Gilenya.
22 April 12 11:49, Globes' correspondent
Novartis AG has added a warning on the US label of its oral multiple sclerosis drug, Gilenya, a competitor of Teva Pharmaceutical Industries Ltd's Copaxone, to help prevent heart problems.
The updated US label says that patients with some cardiac conditions, including heart attack or stroke in the last six months, should not take Gilenya. It says that all patients should have an electrocardiogram before they start using Gilenya, and that they should have a second scan six hours after the first dose of the drug in addition to hourly monitoring of blood pressure and heart rate. Those steps are also recommended for patients whose treatment has been interrupted.
The US label changes are the result of discussions with the US Food and Drug Administration (FDA) that began in December, following cases of heart attacks and strokes in patients who took Gilenya. Novartis is in talks with European Union regulators about other label changes, including warnings against using the drug in patients who are at risk of developing slow or abnormal heart rates.