According to a news release from Public Citizen (March 7, 2009), studies showed that Avandia (along with Rezulin and Actos) were less effective than older drugs at treating type 2 diabetes. Furthermore, Public Citizen noted, studies showed that Avandia, Rezulin and Actos, all of which are in a class of drugs called glitazones, can have adverse effects including liver damage, heart damage, weight gain, fluid retention and low blood pressure.
Public Citizen argued in its news release that the FDA medical officers who reviewed Avandia and the other glitazones knew about the risks before approving the drugs.
"It is outrageous that this critical information is being kept from doctors and patients. They need to be aware of the dangers associated with these drugs," said Dr. Sidney M. Wolfe, M.D., director of Public Citizen s Health Research Group. "These drugs have extremely serious adverse effects and are not as effective as some of the older drugs."
At the time, Public Citizen demanded that the risk of severe liver damage in patients taking Avandia be adequately addressed on the drug's warning label. The organization noted that two published reports had already documented cases of severe liver damage linked to the drug.
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It was not until November 14, 2007, that FDA announced that GlaxoSmithKline, maker of Avandia, had agreed to include a boxed warning about the increased risk of heart attacks in patients using Avandia. This was well after Public Citizen first sounded the alarm about the risks associated with the drug.
Since that time, numerous studies have been released with conflicting data as to whether or not the risk of heart attacks is increased in people who use Avandia. Other studies have shown that the risk of bone fractures is higher in people who use the diabetes medication.