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USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA


A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug Administration or its overseas counterpart, the European Medicines Agency.

Researchers compared adverse drug-reaction data for anticonvulsants and antidepressants marketed by the same pharmaceutical company in both the United States and Europe and found the results to be counterproductive in protecting the public from injury. Among their findings: 77 more adverse drug reactions were reported to the FDA than the EMA involving 12 brand drugs, which generated 24 documents; in those documents, more background about the sources of the adverse drug reactions was reported to the FDA than the EMA. While America seemingly comes out on top in the analysis, it is bad news for Europeans and the medical community as a whole.

“Publicly available drug product documents have the potential to be valuable and vital sources of harm information, but data included in these were found to be inconsistent and not usefully presented,” concludes the report, titled “Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents.” “Identifying, selecting, summarising and presenting multidimensional harm data should be underpinned by practical evidence-based guidelines. Prescribers and patients require reliable reporting of pertinent ADRs to enable them to undertake meaningful informed risk-benefit decisions across competing drug therapies.”

Adverse drug-reaction data should not be reliant on location for its accuracy, head researcher Dr. Victoria Cornelius told Pharmalot.

“Without this information, prescribers cannot appropriately inform patients on the totality of the risks of taking a medicine,” said Cornelius, of the Imperial College of London School of Public Health, in an article titled “Drug makers inconsistently report side effects in the US and Europe.”

Thomas Moore, of the Institute for Safe Medicine Practices, agreed.

“This study shows that the reporting of drug adverse effects on product information is fragmentary and inconsistent,” Moore told Pharmalot. “In this sample, neither the FDA nor the EMA versions provided much information about the onset, duration, and severity of drug side effects. Instead they provided just lists that were not necessarily in agreement.”

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