There are concerns recently arising from how medications associated with diabetes is being regulated. According to an investigation made by the British Medical Journal, the system used in regulating, evaluating and promoting diabetes medications worldwide may be up for further review. According to BMJ Editor-In-Chief Dr. Fiona Godlee, medications for diabetes such as the top-selling drug rosiglitazone, more commonly known for its brand name Avandia should have not been licensed and should even be withdrawn from the market. “There should be better access to raw data used to license drugs, as well as more robust regulatory processes, to allow examination by the scientific community,” Dr. Godlee added. The investigation revealed that the Commission on Human Medicines has advised UK’s regulatory body for drugs, the Medicines and Healthcare Products Regulatory Agency (MHRA), to withdraw rosiglitazone from the market due to the risks that the drug poses may outweigh its benefits. Rosiglitazone has been approved by the FDA in the US in 1999 as well as by the European Medicines Agency or EMA in 2000 to lower blood sugar levels in patients with type 2 diabetes. Since the approvals for the said drug, several studies have linked rosiglitazone to a small overall increase in heart attack risk in people. Despite the risks involved, the drug remains approved for use by those with diabetes. This may raise concerns over how the process of regulating such medications is conducted. There are several concerns regarding the quality of data used by the drug manufacturer, GlaxoSmithKline, to determine whether the drug did not lead to increased heart problem risks compared to other diabetes medications. Another point of concern may be on the lack of publicly available trial results to allow independent scientific scrutiny as well as the lack of transparency, which was the case seen in the European regulating system. Experts believe that an overhaul in the standards of regulatory trials for approving medications may help minimize a similar occurrence in the future. Source: http://www.medicalnewstoday.com/articles/200135.php
Tags: diabetes drugs, diabetes medication, Diabetes News, fda, medication regulation, regulation standards