Roche, maker of drugs such as the cancer drug Avastin, flu medicine Tamiflu, antianxiety drug Klonopin, and the diet pill Xenical, is being investigated by European drug regulators because of potential deficiencies in the way the drug company reported possible side effects in patients in the United States.
The European Medicines Agency identified the problems during a routine inspection of Roche, during which they found about 80,000 reports of possible side effects in drugs sold in the U.S. that had not been followed up on to determine if they were actual adverse reactions that should be reported to drug authorities.
The reports were collected during a program in the U.S. that helps patients deal with health insurance issues. The reports involved dozens of drugs, and among the tens of thousands of possible side effects were more than 15,000 deaths. The European Medicines Agency says it is unclear whether the medications used played a role in any of the reported deaths.
Roche admitted wrongdoing in not reporting the side effects to the U.S. Food and Drug Administration (FDA), but said it is now working to address the matter. Roche has until Wednesday to give the European Medicines Agency a detailed plan on how it will evaluate and report all possible side effects with its medications as well as how it will correct the problem to ensure it won’t happen again.
As for now, European drug authorities are telling patients that they need not stop their current treatment with any Roche medication. People with questions about their medication should talk with their doctors.
Source: Fox News