Avandia's Safety Slammed by New Study

Jenny Albano

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A new German study, published in the Cochrane Library journal, attacked the safety of GlaxoSmithKline's drug Avandia. The study did not find much evidence to support that Avandia improved the lives of people with diabetes. The conclusion of the study was that the drug could actually more complications of the disease worse. Information for this subject was pooled from 18 trials of over 8,000 patients.

Dr. Bernd Richter of Deusseldorf's Heinrich-Heine University, who led the research, said he completed his research separately from Dr. Steven Nissen, even though they came to similar conclusions. Nissen brought the danger of Avandia to the public when he published a study stating that Avandia increased the risk of heart attack by 43%.

The German analysis found Avandia produced about the same reductions in blood sugar levels as other oral anti-diabetic drugs, but patients taking Glaxo's pill gained up to 11 pounds in body weight, and their chance of developing edema, or swelling, doubled. Avandia was also linked to heart failure and bone fractures.

GlaxoSmithKline stated that Richter's study did not give any new evidence and that the study did not look at enough research or enough patients. The company studied Avandia in over 52,000 patients, and the results showed that the drug had a similar safety profile as other drugs for diabetics. The FDA will meet to discuss Avandia's safety on July 30, and Glaxo thinks it has a good argument and evidence.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.