Home : Health : Roche criticized for not adequately reporting side effects The Associated Press Date: Friday Jun. 22, 2012 9:24 AM ET LONDON The European Medicines Agency is investigating "deficiencies" in the way drug maker Roche reported possible side effects in patients in the U.S., though it said there was no evidence patients are at risk. European authorities spotted the problems during a routine inspection of Roche by British regulators in May. They noticed about 80,000 reports of possible side effects for medicines sold in the U.S. had not been analyzed to see if they were truly suspected adverse effects that needed to be reported. The reports were collected in a patient program that helps people deal with health insurance issues in the U.S., like reimbursement for medicines. Dozens of drugs were involved, including many cancer drugs. In the reports of possible side effects, there were more than 15,000 deaths. The European Medicines Agency said it was unclear whether those deaths were linked to any Roche medicines. "The scale of it sounds big, but what is not known is how many of these deaths have already been reported in another way," said Monika Bernstetter, an EMA spokeswoman. "We need … Continue reading →

Swiss pharmaceutical giant Roche is under investigation over a failure to properly report adverse drug side-effects, the European Medicines Agency (EMA) says. Inspectors at the Basel-based company's British site in Welwyn found deficiencies related to Roche's global process of detecting and reporting the adverse effects of medicines. At the time of the inspection, 80,000 reports for medicines marketed by Roche in the US had been collected through a Roche-sponsored patient support program, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected adverse reactions. '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,' the EMA said in the statement on Thursday. 'There is, at present, no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action,' added the EMA. A Roche spokesman said the company acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products. 'Roche is committed … Continue reading →

The European Medicines Agency said on Thursday it was investigating Swiss group Roche Holding AG after a routine inspection found it had failed to properly assess 80,000 cases of possible adverse drug reactions. The issue relates to medicines from across the Roche product range that were part of a financial reimbursement system in the United States. Roche is the world's largest maker of cancer medicines and it also produces drugs for viral infections, central nervous system disorders and inflammatory diseases. "There is at present no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action," the agency said in a statement. The move was triggered by a routine check by British regulators that found Roche had not properly evaluated around 80,000 reports linked to a company-sponsored patient support program dating back to 1997 to see if they should be reported as suspected adverse reactions. These included 15,161 deaths, which may have been due to natural disease progression but may have been connected to the drugs. More recent information from the company indicated fewer reports, but this needed to be verified, the agency said. … Continue reading →