FDA Halts Avandia Study
Posted on behalf of Phillips Law Group on Jul 28, 2010 in Defective Drug
Avandia is a diabetes drug that was released onto the American marketplace by the pharmaceutical giant GlaxoSmithKline in 1999. Since then, Avandia has enjoyed a period of enormous success with several years where more than a billion dollars in revenue was generated by the drug. However, recent years have brought intense scrutiny to Avandia because of a high number of reports of Avandia side effects. Many people who have been harmed as a result of using this medication have sought the help of Avandia side effects lawyers to fight for their rights, and civil lawsuits are not the only type of negative reaction that this drug has generated. Below is a brief overview of the latest development regarding Avandia side effects.
FDA Puts a Stop to Avandia Side Effects Study
Recent weeks have seen a federal panel of experts debate whether or not Avandia should remain on the market on the heels of all of these reports of Avandia side effects. While the panel narrowly voted to allow the drug to remain available for the time being, it also reserved the right to review additional findings that were supposed to define whether the benefits of using Avandia outweigh the risks of serious Avandia side effects that include heart attacks and strokes. An enormous study known as the 'TIDE' study had been commissioned to determine the answer to this question.
However, the FDA has stepped in and halted the process of recruiting subjects for this study. TIDE was supposed to track as many as 16,000 patients, with some using Avandia, others using Actos, which is a competitor of Avandia and a third group using no medication. To date, approximately 1,100 subjects have enrolled in the study. Based on the FDA's position, there will be no additional recruitment for TIDE allowed.
The Risk of Avandia Side Effects Are Too Great
Basically, the FDA put a stop to this study because the risk of developing Avandia side effects was seen as too high and potentially problematic. People should not partake in a study where there is a chance to suffer a heart attack or a stroke. Therefore, TIDE has been put on hold and other outlets will be explored to define whether or not Avandia should remain on the market.
Overall, this issue is not completely relevant to those who have already suffered as a result of using Avandia. If this includes you or someone you love, contact a personal injury lawyer at Phillips Law Group today to schedule a free initial consultation.