The U.S. Food and Drug Administration (FDA) has issued a communication statement on 22nd February, 2010, based on its ongoing large, long-term clinical study called RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) on possible risks with the diabetes drug, Avandia (rosiglitazone; a medication used to treat type 2 diabetes mellitus).
FDA clearly stated that there are no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time. RECORD’s report also demonstrated that rosiglitazone was not associated with an overall increase in cardiovascular hospitalization or death compared to those treated with metformin and sulfonylureas.
Based on this statement and their current ongoing reviews, it is clear that the FDA has considered available scientific evidence on Avandia, and based on the scientific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes.
In a parallel statement consistent with FDA’s advise, The American Heart Association also made a statement on the same day, insinuating the scientific stability of Avandia (rosiglitazone) and encouraging patients to “consult with their physicians on any matters concerning risk factors for heart disease and stroke, such as diabetes”.
In the years since the FDA addressed questions about the cardiovascular safety of rosiglitazone, seven large, prospective, randomized clinical trials that are considered to be the gold standard for evaluating scientific and medical questions, reported that there was no evidence to show any statistically significant association between rosiglitazone and myocardial infarction (heart attack) or other ischemic cardiovascular events.
“When prescribing rosiglitazone, healthcare professionals should follow the recommendations in the drug label” FDA stated in their communication, confirming that “patients should continue taking rosiglitazone unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional”.
FDA recommends that patients currently using rosiglitazone do not stop taking their medication without talking with their healthcare professional, and advises them to discuss their questions or concerns they may have with their healthcare professional.
In addition to the RECORD study, a number of observational studies of the cardiovascular safety of rosiglitazone have also been published. FDA will present a summary of any new possible observational studies of rosiglitazone at the upcoming Advisory Committee meeting in July 2010.
The positive statements by the FDA and AHA has come in support of scientific and research based facts in favor of Avandia in the face of controversial statements in some recent media reports which is seen by GSK as misinterpretation and misstatements, as there has been no call by the US’s FDA to withdraw the Diabetes Type 2 treatment in the US, while EMEA and other global regulators has shown support to the continued availability of Avandia.
