jimmys devoted
02-28-2007, 09:48 PM
February 21, 2007 — The risk for upper arm, hand, or foot fractures may be increased in women receiving rosiglitazone maleate vs metformin HCl or glyburide for type 2 diabetes mellitus, according to a warning from the US Food and Drug Administration (FDA) and GlaxoSmithKline (GSK).
An alert was sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.
The warning was based on data from A Diabetes Outcome Progression Trial (ADOPT), which followed 4360 drug-naive, newly diagnosed patients for 4 to 6 years. The study's primary end point was to compare glycemic control achieved by rosiglitazone, metformin, and glyburide monotherapy.
An alert was sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.
The warning was based on data from A Diabetes Outcome Progression Trial (ADOPT), which followed 4360 drug-naive, newly diagnosed patients for 4 to 6 years. The study's primary end point was to compare glycemic control achieved by rosiglitazone, metformin, and glyburide monotherapy.