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A high anticipated drug to treat patients with relapsed MS may have to undergo further safety checks after side effects including lung and eye disorders were noted in tests.
Reviewers for the FDA in the US said Gilenia, a daily pill alternative to older injectable drugs to treat MS, was “effective”.
But they also noted a number of side effects including eye problems, heart problems and weakened lung function.
Serious side effects occurred in at least 8.5% of patients taking the Novartis’ drug, compared with 5.8% of patients taking older multiple sclerosis drugs.
FDA reviewers complained that there was little data on the long-term effects of using Gilenia.
The FDA will ask a panel of experts whether additional safety studies should be required to assess the drug’s risks. The panel will also vote on whether the drug should be approved. The FDA is not required to follow the group’s advice, though it usually does.
Copyright Press Association 2010
US Food and Drug Administration
