A draft of a new FDA study on Avandia side effects has been released by an FDA scientist. It focuses on Medicare patients nationwide who used Avandia between 2006 and 2009 and were not hospitalized or resident in any sort of nursing home. It is an observational study, meaning that the researchers studied medical records rather than live study participants.
Avandia is a drug offered by GlaxoSmithKline. Its generic name is rosiglitazone and it was FDA-approved in 1998 for treating type 2 diabetes – adult onset diabetes. Although it has probably helped millions of people, its side effects have also hurt many.
Researchers looked at data on 227,000 people over the age of 65 who had used Avandia and compared them with data on people who had used Actos, offered by Takeda Pharmaceuticals and also designed for type 2 diabetes. News reports do not say how many were in this control group.
The study found that Avandia increased certain risks:
- Stroke — 27 percent
- Heart failure — 25 percent
- Death — 13 percent
They estimated that about 48,000 Avandia users had suffered from something caused by Avandia’s side effects. The study looked only at elderly people – but apparently 62 percent of Avandia users have been younger than 65. That led researchers to estimate that probably about 100,000 people nationwide have been adversely affected by Avandia’s side effects.
After a Senate report on Avandia accused GlaxoSmithKline of hiding Avandia’s risks, the FDA has said that it is still looking at the safety data and their conclusions will probably not be released until late summer this year.
There have been other drugs that have caused health problems and organ failure and you can read about some of them at Diseases Caused by Defective Drugs. Our attorneys are well experienced in Prescription Drug Cases and can help if you find yourself in this situation.
If you have been harmed by a defective drug and would like to know more about your legal options, please contact us for a free case evaluation. Our office serves Mobile, Alabama and surrounding areas.