Recently, we reported that the FDA failed to notify the public about one-fifth of the total number of dangerous drug recalls last year. Last week, we told you that the FDA is investigating Fresenius Medical Center’s failure to tell consumers about a potential cardiac arrest risk. And today we learned that Europe’s version of the FDA – the European Medicines Agency – is investigating the world’s largest manufacturer of infection, cancer, and central nervous system disorder meds’ failure to look into side effects.
Specifically, Swiss company Roche Holding AG never evaluated 80,000 adverse drug reports that may or may not have caused more than 15,000 deaths. As of now, it’s unclear whether patients died from side effects or natural causes, according to Reuters. Either way, Roche had a duty to comply with the agency’s reporting system but neglected to do so.
A Roche spokesman told reporters that the patient support program, which provided the reports, did not send possible side effects to the company’s database for evaluation.
The company has until Wednesday to submit a detailed proposal describing how it plans to evaluate and report the cases and what it will do to prevent this from happening again.
Agencies like the FDA and the EMA are responsible for tracking the side effects of all drugs on the market. When companies like Roche fail to notify these agencies of potential health risks associated with their drugs and products, consumers like you are put at risk.
Just ask Actos manufacturer Takeda Pharmaceuticals. The type 2 diabetes drug maker faces thousands of lawsuits that could’ve been avoided had the company properly warned people about the potential risk of bladder cancer. The drug is considered a dangerous drug in countries like Europe, where it’s banned.
Bayer Healthcare is another example. Its Yaz and Yasmin birth control pills, which contain the active ingredient drospirenone, are said to increase the risk of blood clot-related conditions like pulmonary embolism. The company is now in the process of settling Yaz lawsuits with thousands of women.