Avandia FDA Warning
Will there be an FDA Avandia Recall?
The FDA has known about Avandia safety issues for years. Several FDA safety alerts about Avandia and FDA Avandia warning press releases have been issued. A black box warning on the Avandia label and package insert was added to warn of an increased Avandia heart attack risk. Since then, the boxed warning of Avandia heart risks has been expanded to include more FDA safety information to warn of Avandia heart failure risk and heart-related death risk.
In August 2009, data from a long-term clinical study to evaluate Avandia heart risks and cardiovascular safety of Avandia was submitted to the FDA. The "RECORD study" data currently is being reviewed by the drug safety Advisory Committee of the FDA.
In July 2010, the FDA will present its findings to the pubic. An updated assessment of Avandia side effects and the safety of the diabetes drug will be provided. Will there be an Avandia FDA recall?
FDA significantly restricts access to the diabetes drug Avandia
.. The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia. Read more September 23, 2010 New FDA Avandia Restrictions Announced.
The FDA is reviewing RECORD study data submitted in August 2009 on heart risks of diabetes drug Avandia (rosiglitazone).. No new conclusions or recommendations about the use of Avandia (rosiglitazone) in the treatment of type 2 diabetes have been made at this time. After FDA completes its review, the agency will hold a public meeting in July 2010 to 1) present all the known heart-related safety data on Avandia (rosiglitazone); and 2) provide an updated assessment of the risks and benefits of Avandia (rosiglitazone) in the treatment of type 2 diabetes. Read more February 23, 2010 FDA Avandia RECORD study data safety review update.
FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety. The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia* (rosiglitazone). The clinical study, called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes or RECORD study was designed to evaluate the cardiovascular safety of rosiglitazone, a medication used to treat type 2 diabetes mellitus. Read more February 22, 2010 Avandia FDA Drug Safety Announcement.
FDA adds Boxed Warning for heart-related risks to anti-diabetes drug Avandia. The FDA announced today that the manufacturer of type 2 diabetes drug Avandia (rosiglitazone) has agreed to add new information about potential increased risk of heart attack to Avandia's existing black box warning label. FDA alerts type 2 diabetes patients with underlying heart disease or who are at high risk of heart attack to talk with their doctor about the revised warning. FDA warns health care providers to closely monitor diabetes patients who take Avandia for cardiovascular risks. Read more November 14, 2007 FDA adds Boxed Warning for heart-related risks to anti-diabetes drug Avandia.
FDA Avandia Drug Safety Alert: Important revisions to the full prescribing information (adding a new Black Box warning on the label) for rosiglitazone maleate, marketed as Avandia, Avandamet, and Avandaryl. The updated Avandia drug safety information label includes a new BOXED WARNING highlighting increased risk of congestive heart failure associated with Avandia. Read the August 14, 2007 FDA Safety Alert on Avandia.
FDA Avandia Drug Safety Alert: Important revisions to the full prescribing information (adding a new Black Box warning on the label) for rosiglitazone maleate, marketed as Avandia, Avandamet, and Avandaryl. The updated Avandia drug safety information label includes a new BOXED WARNING of a an increased risk of heart attack (myocardial ischemia) and heart-related death in type 2 diabetes patients taking Avandia. Read the May 21, 2007 FDA Safety Alert on Avandia.