EMA to investigate Roche over drug-safety reporting failures22 June 2012 by Liam Stoker
The European Medicines Agency has announced it is to investigate Roche after it found that the company failed to properly assess 80,000 cases of possible adverse reactions to drugs.
A routine check carried out by British regulators uncovered that Roche failed to evaluate reports linked to a patient support programme sponsored by the company to see whether or not they were to be reported as suspected adverse reactions.
Of the 80,000 cases, more than 15,000 reports of death of patients were included and it is not yet known whether the deaths were a cause of natural disease progression or had a causal link to the medicine.
The European Medicines Agency did move to allay patient fears, with the agency stating, "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 also uncovered other deficiencies at Roche, with the failure to report approximately 23,000 possible cases of adverse reactions to national medicines agencies and a further 600 incidents involving patients within clinical trials.
Roche has responded to the investigation by announcing its intent to provide a final assessment of the potentially missed adverse events by January 2013.
"Roche acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products," the company said in a statement.
"Roche is committed to actively pursuing corrective and preventative actions to address this matter expeditiously. The non-reporting of these potentially missed adverse events was not intentional."
Image: Roche headquarters located in Basel, Switzerland. Image courtesy of Roche.