FDA to Investigate Diabetes Drug Saxagliptin
Marketed as Onglyza and Kombiglyze XR, drug appears to have no effect on heart attack or stroke risk
WebMD News Archive
In a journal editorial accompanying the September NEJM study, experts noted that after Avandia gained FDA approval in 1999, one highly publicized review published in 2007 "reported a 43 percent increase in [heart attacks] and a 64 percent increase in death from cardiovascular causes" tied to use of the drug.
The editorial authors said the Avandia experience led the FDA to be highly cautious in its oversight of new diabetes medications. In 2008, the agency issued a new rule mandating that "pre-approval and post-approval studies for all new anti-diabetic drugs rule out excess cardiovascular risk."
Speaking at the time of the NEJM study's release, co-author Dr. Itamar Raz, head of the Prevention of Diabetes and Diabetes Clinical Research Center at Hadassah Medical Center in Israel, stressed that saxagliptin also showed benefits for patients.
"Patients who received saxagliptin also had better control of blood sugar levels and a reduced need for insulin therapy," he noted. Raz added that the diabetes drug also prevented the progression of microalbuminuria, a condition that occurs when a type of protein called albumin is spilling into the urine due to kidney damage.
Still, the final chapter on saxagliptin may have to wait until the FDA issues its findings on the detailed trial data.
Meanwhile, one expert said it's not easy for the millions of Americans with type 2 diabetes to know which drug is best for them.
Dr. Tara Narula, associate director of the cardiac care unit at Lenox Hill Hospital in New York City, said at the time of the study's publication that "there currently exists a tremendous amount of confusion regarding which diabetes drugs are safe to use in patients at risk for or with established cardiovascular disease."