[News] Hooray for The European Medicines Agency

[epileric]

LONDON — The European Medicines Agency is investigating "deficiencies" in the way drug maker Roche reported possible side effects in patients in the U.S., though it said there was no evidence patients are at risk.

European authorities spotted the problems during a routine inspection of Roche by British regulators in May. They noticed about 80,000 reports of possible side effects for medicines sold in the U.S. had not been analyzed to see if they were truly suspected adverse effects that needed to be reported. The reports were collected in a patient program that helps people deal with health insurance issues in the U.S., like reimbursement for medicines. Dozens of drugs were involved, including many cancer drugs.

In the reports of possible side effects, there were more than 15,000 deaths. The European Medicines Agency said it was unclear whether those deaths were linked to any Roche medicines.

Roche criticized for not adequately reporting side effects

 

[Silat]

Whoa....