Recent recommen
dations released as part of a report from the Senate Finance Committee on the controversial drug, may spell the doom for GlaxoSmithKline’s multi-billion dollar diabetes drug Avandia as it has been linked to heart problems.
The call for the drug’s demise comes as Dr. David Graham and Dr. Kate Gelperin, both epidemiologists with the FDA, say that Avandia is responsible for about 500 additional heart attacks and 300 additional cases of heart failure each month than would occur if competitor Actos were used exclusively.
Avandia, chemically referred to as rosiglitazone, works as well as pioglitazone or Actos and helps to lower blood sugar levels in type 2 diabetic patients by increasing the sensitivity of liver, fat and muscle cells to insulin. This enables these cells to remove sugar from the blood more effectively.
A report from the Institute for Safe Medication Practice, linked Avandia to 304 deaths in the third quarter of 2009 alone, the highest for any prescribed drug in that time period, the Times reported. Scientists began questioning the efficacy of Avandia after a study released in early May of 2007 by the Cleveland Clinic suggested that Avandia carried cardiovascular risks. That study, which included more than 28,000 people, found that Avandia increased a user’s odds of heart attack by 43 percent compared to those not taking the medicine.
The ongoing controversy has dampened patients’ and physicians’ enthusiasm for Avandia. According to the Times, while sales of the drug topped $3.2 billion in 2006, those numbers plummeted soon after the first studies suggesting risk emerged a year later. “I haven’t prescribed Avandia for some time now, and I am not surprised that the recommendation is to pull it off from the market,” said Dr. Albert Levy, assistant professor of medicine at the Mount Sinai School of Medicine in New York. “Any medicine with such a bad reputation is a potential life-threatening risk for the patient and a possible malpractice risk for the doctor.”
While FDA is still evaluating cardiovascular safety of rosiglitazone, Times reported that hundreds of thousands of patients still continue to take the medicine world over.
Written by Snigdha Taduri for Biomed-ME