European Medicine Agency Recommends Suspension of Dozens of Medications

The European Medicine Agency, the FDA of the European Union, has recommended the suspension of approvals for dozens of generic medications due to problems detected in studies conducted leading to the approval of these medications.    Although none of the medications are used to treat ADHD, they include common medications such as metformin, candesartan, and desloratidine (US brandname Clarinex).  Also included are antipsychotic quetiapine, antidepressants escitalopram and venlafaxine, and anxiolytic clonazepam.

The EMA states that inspection of GVK Biosciences' Hyderabad facility revealed that study data had been manipulated in a "systematic way" over a 5 year time span.  An FDA investigation immediately following revealed that no harm was likely to have arisen from the data manipulations and the FDA is not planning to suspend any approvals in the United States, even though several approvals have gone through the agency with data from the flawed studies.

It is important to note that the EMA is allowing member states to continue to sell medications that may be critical to health if there is no alternative available.  However, this may force patients to switch to other medications that may not be as effective for them.