http://www.ema.europa.eu/ema/index.j...01ac058004d5c1
At the time of the inspection the company identified some 80,000 reports for medicines marketed by Roche in the USA that had been collected through a Roche-sponsored patient support programme, but which had not been evaluated to determine whether or not they should be reported as suspected adverse reactions to the EU authorities. These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine. More recent information from the company indicates a smaller number of reports, but this information needs to be verified by the authorities.
80,000 safety reports and 15,161 deaths go unreported. Wow what next...
At the time of the inspection the company identified some 80,000 reports for medicines marketed by Roche in the USA that had been collected through a Roche-sponsored patient support programme, but which had not been evaluated to determine whether or not they should be reported as suspected adverse reactions to the EU authorities. These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine. More recent information from the company indicates a smaller number of reports, but this information needs to be verified by the authorities.
80,000 safety reports and 15,161 deaths go unreported. Wow what next...