A February 2007 press release by GlaxoSmithKline notes a greater incidence of fractures of the upper arms, hands and feet in female diabetics given rosiglitazone compared with those given metformin or glyburide.[2] The information was based on data from the ADOPT trial.[3]
An article to be published in the June 14, 2007 print issue of New England Journal of Medicine tied the use of rosiglitazone to a slightly increased risk of heart attack (odds ratio=1.43).[4][5] The FDA issued an alert on May 21, 2007.[6] The findings of the study by Dr. Steven Nissen and his colleague Kathy Wolski, were considered enough of a public health matter to have caused the New England Journal of Medicine to release the findings several weeks before they appeared in print.
References
Mohanty P, Aljada A, Ghanim H, Hofmeyer D, Tripathy D, Syed T, Al-Haddad W, Dhindsa S, Dandona P (2004). "Evidence for a potent antiinflammatory effect of rosiglitazone". J Clin Endocrinol Metab 89 (6): 2728–35. PMID 15181049.
Cobitz, Alexander R (February 2007). Clinical Trial Observation of an Increased Incidence of Fractures in Female Patients Who Received Long-Term Treatment with Avandia® (rosiglitazone maleate) Tablets for Type 2 Diabetes MellitusPDF (49.9 KiB). GlaxoSmithKline. Retrieved on 2007-04-10.
Kahn S, Haffner S, Heise M, Herman W, Holman R, Jones N, Kravitz B, Lachin J, O'Neill M, Zinman B, Viberti G (2006). "Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy". N Engl J Med 355 (23): 2427–43. PMID 17145742.
Nissen SE, Wolski K (2007). "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes". N Engl J Med. DOI:10.1056/NEJMoa072761. Free full text with registration
Associated Press. "Diabetes drug linked to heart attacks, death", MSNBC, May 21, 2007. Retrieved on 2007-05-21.
FDA. "FDA Issues Safety Alert on Avandia", May 21, 2007.
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