A European drug regulatory agency is accusing the pharmaceutical company Roche of failing to properly report potentially serious side effects linked to nearly 20 drugs, including Avastin, Herceptin and Tamiflu.
The European Medicines Agency (EMA) announced yesterday that it has filed “infringement proceedings” against drug giant Roche, for allegedly failing to report side effects associated with medications that are also widely used by patients in the United States.
Like in the United States, strict guidelines are maintained by the European Union regarding the reporting of suspected side effects, requiring drug companies to submit reports on adverse events to officials.
European authorities indicate that Roche had “serious shortcomings” in how they reported potential side effects.
Roche Failed to Analyze 80,000 Drug Side Effects
The EMA initially began investigating Roche in June 2012, over failing to properly analyze 80,000 reports of side effects, including more than 15,000 deaths. It is not clear whether the deaths are linked directly to Roche medications.
The European Commission, an executive body governing 27 European countries, asked the EMA to begin the proceedings, the first of its kind to be filed by the EMA, against Roche.
Eight of the 19 drugs in question are cancer fighting medicines, including Avastin, Herceptin, Tarceva and Xeloda. The company’s blockbuster flu drug, Tamiflu, is also among the drugs listed.
Avastin is used to treat lung and colorectal cancer, in combination with chemotherapy. It prevents the formation of new blood vessels in tumors, starving them and inhibiting their growth.
In 2008, Avastin was approved for the use of breast cancer, however that approval was later revoked by the FDA in 2010, because the drug failed to show that it prolongs the life of breast cancer patients or improves their quality of life.
The drug has come under further scrutiny following claims of adverse effects such as high blood pressure, hemorrhaging, heart attacks, heart failure and has also been linked to the development of perforations in the nose, intestines and stomach.
Herceptin is also used to treat breast cancer, often in combination with other chemotherapy drugs called anthracyclines. Much like Avastin, Herceptin has also been questioned regarding major side effects from use.
Recent studies regarding the drug have found numerous adverse effects including an increased risk of heart failure, asymptomatic cardiotoxicity and congestive heart failure.
If Roche is found to be in violation, the company may be fined up to five percent of sales from last year. The EMA is allowed 18 months to complete the infringement investigations before the European Union will decide if the company should be penalized.