Roche probed over faulty drug-safety reporting

Swiss pharmaceutical giant Roche is under investigation over a failure to properly report adverse drug side-effects, the European Medicines Agency (EMA) said on Thursday.

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 programme, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected .

"These included 15,161 reports of death of patients and it is not known whether the deaths were due to of the disease or had a causal link to the medicine," the EMA said in the statement.

"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 to actively pursuing corrective and preventative actions to address this matter expeditiously," it added. "The non-reporting of these potentially missed adverse events was not intentional."

The EMA is the equivalent of the and regularly carries out inspections to ensure correct adverse drug reporting.

This is meant to identify problems with drugs by recording when a patient dies or has a medical setback, even if they have an underlying disease.

add to favorites email to friend print save as pdf

Related Stories

Recommended for you

WHO: Millions of Ebola vaccine doses ready in 2015

10 hours ago

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March.

Added benefit of vedolizumab is not proven

Oct 23, 2014

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

Oct 22, 2014

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments