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Friday, July 20, 2012

Failing to report

Roche, one of the world's biggest drug companies, is at the centre of an investigation after failing to report that people died while taking their medication. Roche, which made profits of £6.3 billion in 2010, has a legal duty to examine every suspected side effect and report them to regulators around the world so that potential safety concerns can be investigated. This means that each side effect reported to the patient support call centre should have been immediately sent to the safety team to be assessed. These must then be sent to regulators – within 15 days for the most serious reactions – even if no link between the drug and the reaction be proved.

15,000 people died while taking its medicines. Roche also failed to pass on a further 65,000 reports of suspected side effects that were recorded by patient.

http://www.dailymail.co.uk/news/article-2170317/Roche-investigation-UK-watchdogs-80-000-adverse-reactions.html

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