LONDON — Europe's top drug regulator announced yesterday it is taking action against pharmaceutical giant Roche for allegedly failing to properly report the side effects of 19 drugs being used by US patients.
It is the first time the European Medicines Agency has begun a so-called 'infringement proceeding' against a drug maker. European regulations lay out numerous requirements for pharmaceuticals, including reporting suspected side effects and submitting such cases to officials.
Eight of the drugs involved are used for the treatment of cancer, including breast cancer. They include Avastin, Herceptin, Tarceba, and Xeloda. The flu drug Tamiflu was also included in the list.
British authorities brought the problem to the attention of the European authorities in May after noticing "serious shortcomings" in how Roche AG reported potential side effects.
Regulators said about 80,000 reports by consumers of possible adverse effects to drugs sold in the US had not been properly analyzed. Among those reports were over 15,000 deaths, though it was unclear if those deaths were caused by Roche medicines.
The regulator said there was no evidence that users of Roche's drugs were at risk.
The European Medicines Agency did not state what the side effects were but said it was more concerned that these potential reactions were not properly reported.
"It could have been anything like a rash on your hand to something more serious," including death, said Monika Benstetter, an agency spokeswoman. "There was a failure in the system," she said, noting officials didn't have information on how many of the side effects may have been reported.
If Roche is found to have violated its reporting requirements, it could be fined up to five per cent of its sales revenue in the European Union from the preceding year.