Posts Tagged 'European Medicines Agency'

Drug maker Roche failed to properly report drug side-effects

The European Medicines Agency has announced it’s investigating reports that Swiss drug maker Roche AG failed to properly report about 80,000 reports of possible side effects in the U.S.

According to a report on Medical Xpress, European regulators spotted the problems during a routine inspection. The inspectors found that Roche had not properly analyzed the accounts of possible side effects to see if they were truly suspected adverse events that needed to be officially reported.

The reports included many different types of ...

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FDA issues stricter warning for epilepsy drug Gilenya

The U.S. Food and Drug Administration has reviewed Novartis AG’s multiple sclerosis drug Gilenya, and concluded that patients who’ve suffered a heart attack or stroke within the past six months shouldn’t take it.

The review came about after a 59-year-old patient died in November, less than 24 hours after taking the first dose of the drug.

Europe’s drug regulator, the European Medicines Agency, recently requested stronger safety warnings for Gilenya after the agency concluded its review of the drug.

According to Dow Jones ...

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