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Medical News Today (MNT), reported that pharmaceutical company Roche Registration is under investigation by the European Medicines Agency (EMA) because it failed to report 80,000 cases of potential side effects associated with 19 of its drugs. The company faces nearly $685 million in fines.
According to the news source, Roche claimed that the reports of side effects did not come from clinical trials, but from programs in the U.S. in which patients who could not afford the medications were issued the drugs, and that is why they weren't in the Roche database and the European Union authorities weren't notified. Although, MNT notes, the pharmaceutical company should have notified the health authorities of the side effects rather than relying on them looking at their database.
Two of the drugs that may have unreported side effects include Herceptin, a cancer medication, and Tamiflu, which is used to treat influenza, which can be detected with a lab test.
The investigations started earlier this year when the organization Medicines and Healthcare Products Regulatory Agency (MHRA) reported that the pharmaceutical company had not been vigilant in assessing the thousands of reported cases of potential risk factors.
According to Reuters, Roche is the largest producer of cancer medications and it also manufactures drugs to combat viral infections, central nervous system disorders and inflammatory diseases.
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