Update 2/22/10: FDA is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, rosiglitazone (Avandia). The clinical study, called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD), evaluated the cardiovascular safety of rosiglitazone among patients with type 2 diabetes.

In addition to RECORD, a number of observational studies of the cardiovascular safety of rosiglitazone have been published. FDA has been reviewing these on an ongoing basis.

FDA is reviewing primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies. This work is 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.

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Update 9/25/09: FDA is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.

Eighty-eight postmarketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis, in patients using sitagliptin were reported to the Agency between October 16, 2006 and February 9, 2009. Based on these reports, FDA is working with the manufacturer of sitagliptin/metformin to revise the prescribing information to include:

• Information regarding postmarketing reports of acute pancreatitis, including hemorrhagic or necrotizing pancreatitis
• Recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin, and to discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected during use of these products
• Information noting that sitagliptin has not been studied in patients with a history of pancreatitis

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Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin^®), Simvastatin (marketed as Zocor^®) and Ezetimibe (marketed as Zetia^®)

FDA Investigates a Report from the SEAS Trial

Update 8/21/2008: This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product. FDA is considering but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available. 

FDA is investigating a report from the SEAS trial (Simvastatin and Ezetimibe in Aortic Stenosis) of a possible association between the use of Vytorin^® (a combination of simvastatin plus ezetimibe) and a potentially increased incidence of cancer. Simvastatin (Zocor^®), a “statin” class drug approved in 1991, decreases production of cholesterol by the liver and is indicated to reduce LDL-cholesterol levels and the risk of cardiovascular events such as heart attack and stroke. Ezetimibe (Zetia^®), approved in 2002, inhibits the absorption of cholesterol in the intestine and is indicated to reduce LDL-cholesterol levels. Vytorin, the combination product approved in 2004, is indicated to reduce LDL-cholesterol levels.

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Update 8/21/2008: Since issuing information for Healthcare Professionals in October 2007, FDA has received reports of six cases of hemorrhagic or necrotizing pancreatitis in patients takin Byetta^®. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the six cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died, and four patients were recovering at time of reporting. Byetta was discontinued in all six cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

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