Friday, October 26, 2012

Roche Investigated For NOT Reporting SIDE Effects!!!

Europe’s top drug regulator announced that it is taking action against pharmaceutical giant Roche for allegedly failing to properly report the side effects of 19 drugs

roche investigated

If Roche is found guilty the company can be fined up to 5% of the price of their sales across the European Union

European Medicines Agency (EMA) announced that it is taking measures against the pharmaceutical manufacturer Roche which has not reported side effects of 19 of their medicines.
Eight of these drugs are used to treat cancers, including breast cancer. These include Avastin, Herceptin, Tarceva and Xeloda. Tamiflu is also listed.
British authorities draw the attention of European regulators to the problem in May when they see “serious deficiencies” in the reporting of side effects.
80,000 reports of adverse events submitted by users were not analyzed correctly. These include reports of 15,000 deaths, although it is unclear whether they are caused by drugs of Roche.
From EMA are calming down the consumers that they are not at increased risk. Authorities refused to describe what the side effects are, but only said that they are concerned of that they were not timely notified of them, which is a serious flaw in the system.
If Roche is found guilty the company can be fined up to 5% of the price of their sales across the European Union for the last year. The company’s shares lost 2 percent of its value on Tuesday when the scandal was announced.
The European Commission, the executive body of the EU, asked the European Medicines Agency to initiate criminal proceedings. A statement from the agency said that it will investigate the allegations against Roche.
EMA sends the manufacturer a detailed indictment list and is currently awaiting the response of the company. The investigation could take up to 18 months, after which the Commission must decide whether to impose sanctions.
Daniel Grotzky – Roche’s spokesman, said that the company is working with EMA to clarify the case and does not want to speculate on the subject. He said that patients’ safety is “of paramount importance”.


Source : dailyhealtharticles[dot]com

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