LONDON (AP) — A European agency is investigating a multiple sclerosis
drug made by industry giant Novartis to determine whether the medicine
played any role in the deaths at least 11 patients.
The drug,
Gilenya, was licensed last year in the European Union to treat a severe
type of multiple sclerosis. It can cause a slow heart rate when first
taken and doctors closely monitor patients after the first dose.
The
European Medicines Agency, which is now investigating the drug, said it
isn't clear if it caused the deaths. One of the fatalities occurred in
the United States, 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.
Novartis said not all the deaths were heart related.
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 had previously said all patients
should be monitored for six hours after their first dose, but are now
tightening that to include continuous heart monitoring using
electrocardiograms and measuring blood pressure and heart rate every
hour. In certain patients, that monitoring should be extended, the drug
maker said in a statement.
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.
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