June 25th, 2012|
June 25, 2012
It has recently come to light that numerous drug injuries may have been overlooked in reports about the possible side effects of medications manufactured by Roche. According to The Sacramento Bee, the European Medicines Agency (EMA) discovered the discrepancies last month during a routine audit.
The agency found that roughly 80,000 reports of adverse events, including 15,000 deaths which could be connected to Roche medications, have never been analyzed.
These reports were collected after the drugs went on the market as the company’s way to ensure that adverse events that may otherwise be missed during clinical trials are caught and corrected.
Roche acknowledged the problem by saying that the company’ reporting system failed to receive the information about the adverse events, therefore the information was never passed on to health officials. The company stated that the oversight was not intentional and that they were working vigorously to remedy the problem.
EMA spokeswoman Monika Benstetter added, “Based on the information we have, there is no need for patients to change their treatment, but we need more evidence that these deficiencies are being addressed.” Roche has until Wednesday of this week to offer a proposal on how the company plans to evaluate all of the reports.