The U.S. Food and Drug Administration announced that it could possibly end a diabetes drug trial based on the potential dangerous side effects of the popular diabetes medication Avandia. FDA Commissioner Margaret Hamburg wrote in a letter to the U.S. Senate that the decision to possibly stop this study stems from ethics issues, as a possible recall of Avandia looms due to allegations of heart risks.
The study in question is a comparative research trial for both Avandia – manufactured by GlaxoSmithKline – and the similar medication Actos, which is manufactured by Takeda Pharmaceutical. Hamburg and the FDA are worried that encouraging the use of the drugs on the patients involved with the trial could be unethical, further exposing consumers to the alleged dangers and potential heart risks associated with Avandia. Thus, if the study is ended, it would likely foreshadow a full recall of Avandia and related diabetes medication.
The TIDE Trial (Thiazolidinedione Intervention With Vitamin D Evaluation) is still actively recruiting patients for testing while the FDA makes a decision on the fate of Avandia and related drugs. The FDA will make a final decision in July when an advisory panel will determine if the trial is indeed unethical.
In 2007, the FDA formed a committee of medical professionals to examine Avandia and its reported side effects in order to determine if the drug should remain available for prescription use, as well as its affect on the heart. The committee found that the drug did pose heart risks, but was safe enough to remain on the U.S. market. GlaxoSmithKline received a black box warning for Avandia.
Avandia has been a popular prescription treatment for type-2 diabetes since it was approved for use by the FDA in 1998. The drug first caused concern in 2007 when a cardiologist from the Cleveland Clinic published findings that supported theories that patients using Avandia were at a greater risk of suffering heart problems than those who were not. The drug’s manufacturer later released statistics and research of its own that validated the original reports.
If you or a loved one has experienced serious side effects, a heart attack or other health complications from using Avandia, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.