The European Medicines Agency has announced it’s investigating reports that Swiss drug maker Roche AG failed to properly report about 80,000 reports of possible side effects in the U.S.
According to a report on Medical Xpress, European regulators spotted the problems during a routine inspection. The inspectors found that Roche had not properly analyzed the accounts of possible side effects to see if they were truly suspected adverse events that needed to be officially reported.
The reports included many different types of drugs, including cancer drugs, and were collected in a U.S. patient program that helps people deal with health insurance issues.
Those reports included 15,000 deaths, although a European Medicines Agency spokeswoman said there was no evidence the deaths were linked to Roche medicines, or that patients are at risk.
According to Medical Xpress, drug agencies regularly track side effects of drugs on the market. That’s because rare adverse events might not have been picked up during clinical trials, in which only limited numbers of people are exposed to the medicines.
The EMA has ordered Roche to submit a detailed plan on how they will evaluate and report all outstanding cases, including how such problems will be corrected in the future.
See the report here: