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October 21, 2005
New Diabetes Pill Deemed Dangerous
A new diabetes pill that was headed for government approval has been linked to deaths, heart attacks and strokes, a medical journal reported Thursday in an analysis it said was rushed online to head off a Vioxx-like fiasco
The study by leading heart researchers found twice as many deaths and cardiovascular problems in diabetic adults taking the drug Pargluva as those on dummy pills or a competing drug.
Muraglitazar is a new drug developed to both lower blood glucose levels and improve blood lipids in patients with type 2 diabetes. On September 9, 2005, a US Food and Drug Administration (FDA) advisory panel strongly recommended approval of muraglitazar, and on October 18, 2005, the FDA issued an "approvable letter" for the drug. However, in a review of data from Phase 2 and 3 trials conducted by the drug manufacturer and provided to the FDA, Nissen and colleagues found that muraglitazar was associated with an excess incidence of the composite endpoint of death, major adverse cardiovascular events, and congestive heart failure.
Posted by Diabetologica at October 21, 2005 1:14 PM