EMA: No new safety flags in Roche's stash of unreported side effects

Roche ($RHHBY) can breathe a sigh of relief now that a European Medicines Agency (EMA) probe has wrapped up. The Swiss drugmaker did fail to flag tens of thousands of side-effect reports, EMA reviewers said. But sifting through those unreported adverse events didn't turn up any new safety worries on Roche's leading drugs, as some had feared.

Last May, EMA inspectors at Roche uncovered a cache of reports about potential drug side effects. And it was a big cache: 80,000 adverse-event reports that weren't properly processed or investigated, the EMA said at the time. The agency launched a safety review posthaste. The worry was that some of Roche's most-used drugs--including the cancer treatments Avastin and Herceptin--were associated with side effects heretofore unknown.

Now, Roche says the number of unreported side effects was revised downward, to about 23,000, Reuters reports. And the EMA says it has reviewed all of them--and found no new red flags. The data covered 19 medications approved under Europe's centralized review process, including the flu fighter Tamiflu, the melanoma treatment Zelboraf, the cancer and arthritis treatment MabThera, and the bone drug Boniva, in addition to Avastin and Herceptin.

"The balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use," the EMA said in a statement, adding that patients should continue using these drugs as prescribed.

This doesn't mean Roche is completely clear of trouble in this case. As Reuters notes, the company could still face regulatory action for falling short of its responsibilities under European pharmacovigilance rules. The company says it has changed its procedures on collecting data about adverse events to make sure that reports are processed and analyzed as required.

- get the statement from the EMA
- read the Reuters news

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