FDA Announces Restrictions in Response to Avandia Side Effects
The FDA is charged with overseeing and regulating many things that come into contact with the American public, and one of them is prescription drugs. This need for regulation has grown intense in recent times in regards to Avandia, one of the most popular and widely-used medications designed to help people manage their type 2 diabetes. The FDA is acting in response to reports of serious Avandia side effects, and Avandia side effects lawyers are getting involved on behalf of clients all over the country. Below is a brief overview of the actions taken by the FDA in response to the Avandia side effects issue.
FDA and Restricted Access Due to Avandia Side Effects
Specifically, the FDA has announced that GlaxoSmithKline, the manufacturer of Avandia, is hereby ordered to develop a restricted access program for those who want to use Avandia to treat their type 2 diabetes. This basically means that people will only be allowed to begin using Avandia if other medications have not performed properly and if these patients are unable to use Actos, another diabetes drug, for whatever reason. Those patients who have been using Avandia will be allowed to continue to do so, but those who begin using Avandia must be thoroughly warned of the dangers of Avandia side effects that include a heightened risk for heart attacks and strokes.
FDA Scrutinizes Avandia Side Effects Studies
In addition to the announcement above, the FDA also announced that GlaxoSmithKline must convene an independent review of the RECORD study, which was performed in order to measure the risks of heart attacks and strokes in Avandia users. The FDA has questioned the bias that could have been involved in the conclusions as well as the manner in which certain events were recorded. Finally, the FDA has killed what is known as the TIDE study, which was ongoing and was being done to compare Avandia to Actos.
If you or someone you love has been harmed because of using Avandia, contact the Avandia side effects lawyers at Phillips & Associates today to schedule a free initial consultation.