Audience: endocrinology, cardiology health care professionals, patients
February 22, 2010 — The FDA notified health care professionals and patients that it is reviewing the primary data from a large, long-term clinical study — RECORD — about possible cardiovascular risks associated with the diabetes drug Avandia (rosiglitazone). In addition to the clinical trial, a number of observational studies of the cardiovascular safety of rosiglitazone have been published and FDA has been reviewing these.
These reviews are ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time. Once the FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a public meeting in July 2010. The agency will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.
The FDA recommends that health care professionals follow the recommendations in the drug label when prescribing rosiglitazone. This includes a Boxed Warning. Patients should continue taking rosiglitazone unless told by their health care professional to stop. Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their health care professional.
February 22, 2010 — ongoing review of Avandia (rosiglitazone) and cardiovascular safety
