Diabetes Drug Side Effects Reports Triple
On May 21, 2007, the New England Journal of Medicine published an internet analysis of the Avandia. It revealed that Avandia, a popular diabetes drug made by GlaxoSmithKline, is linked to heart risks. In the days following this analysis, reports of heart attacks, hospitalizations, and deaths tripled. For example, in the thirty-five days before the analysis was published, there were five heart attacks reported. In the thirty-five days following this analysis, ninety were reported (more than tripled). The Associated Press received this information from the federal Food and Drug Administration after presenting them with a Freedom of Information Act request.
What Caused Side Effects Reports to Suddenly Triple?
When the New England Journal of Medicine released their findings, it was a shock. Most doctors had no idea that their diabetic patients on Avandia were at increased risk. When the analysis and the risks were connected, doctors were able to link the diabetic patients on Avandia and their new heart problems. That knowledge equipped them to report the problems.
What does Avandia do for Patients?
Avandia was developed to help diabetic patients control their blood sugar. So far it has helped six million people worldwide to manage their Type 2 diabetes. In eighteen published studies of randomized controlled trials with more than eight thousand participants, Avandia performed its function-controlling blood sugar-about equally in comparison to other oral anti-diabetic drugs. When these same studies looked at the patient side of these drugs-side effects, complications, or death-they discovered a very negative side of Avandia.
What are the Side Effects?
Pooling the data from the previously mentioned eighteen studies and more than eight thousand participants, serious problems were revealed. These diabetic patients gained up to eleven pounds, increasing their risk for edema (swelling), and causing possible water retention. Fluid retention can cause shortness of breath and heart failure.
What are the Safety Information Warnings about Avandia from GlaxoSmithKline?
GlaxoSmithKline, in Avandia's official website www.Avandia.com, warns, "For some people taking Avandia, possible side effects include heart failure or other heart problems." It says that the FDA has made information on its website available to doctors about the related risks. The website warns about taking Avandia if there are liver problems. In addition, the website cautions people to speak with their doctors about how to keep their bones healthy. "More fractures, usually in the arm, hand, or foot have been seen in women taking Avandia." Women are also warned that Avandia may increase their risk for pregnancy. The website also lists another serious warning to have the patients get their eyes checked regularly. "Some people have experienced vision changes due to swelling in the back of the eye while taking Avandia."
Additional Side Effect Reports that Tripled
Only fifty side effects were reported in January and seventy-three in February. From April 16 to May 21, when the analysis was published, 121 problems were reported. In the thirty-five days after the study, there were 357 problems reported, and thirty-eight of these were deaths. It seems that the FDA approved this drug without all of the information. Doctors can only act on what they know, and once the drug is approved, they assume it is safe for their patients. Diabetics are at increased risk of heart deaths because of diabetes. This additional risk does not justify the use of Avandia in diabetic patients.