A US consumer group pressing to have a diabetes drug banned said on March 9 that diabetics and their doctors are not being sufficiently warned about possible liver or heart damage that may occur with three popular drugs in the class. The group, Public Citizen, petitioned the US Food and Drug Administration (FDA) to require stronger warnings on the drugs, Rezulin, Avandia and Actos, which are used to treat type 2, or adult-onset, diabetes.
The drugs' labels downplay or fail to mention possible liver and heart damage and other side effects, said Public Citizen, which is most concerned with Rezulin, a drug linked to liver-failure deaths. The advocacy group says Rezulin should be banned.
The FDA said 58 patients taking Rezulin have died from liver failure. Regarding Avandia, made by SmithKline Beecham Plc, FDA officials have identified one case of liver failure "possibly or probably" related to the drug. The company, however, does not believe Avandia is to blame and that present information discloses all safety and efficacy information.
Other possible side effects include weight gain, fluid retention, low blood pressure, anemia and changes in hormone levels, the petition said. Also, studies show the three drugs are less effective than some older diabetes drugs. It is outrageous that this critical information is being kept from doctors and patients.
Drugs are not the way to control diabetes. It is the rare case where rigid application of diet and exercise will not control this problem. I can only think of a handful of patients I have treated who have not responded incredibly well to a rigid restriction of grains and an increase in their cardiovascular exercise program.