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FDA Puts Halt on Avandia Side Effects Study Enrollment

July 27th, 2010 by Legal Advocate, in Blog

Avandia is a diabetes drug that has come under intense scrutiny from government officials, medical professionals and Avandia side effects lawyers who have been helping those who have been injured as a result of using this drug.  For almost three years, GlaxoSmithKline, has found itself defending the safety of Avandia amid claims that it leads to serious harm.  Recently, a federal panel of officials voted by a slim margin to allow Avandia to remain on the market until additional information can be collected.  Unfortunately for GlaxoSmithKline, one of the main efforts to gather this information has been stopped in its tracks.

Avandia Side Effects Study

This main effort that was mentioned above concerned what has been known as the ‘TIDE’ study.  This study was supposed to recruit up to 16,000 patients to take part in this study, and it would involve some subjects taking Avandia and others taking Actos, which is a competitor of Avandia.  There would also be a control group that would take no medication at all.

The purpose of the TIDE study was to attempt to definitively measure the likelihood that someone who was taking Avandia would develop Avandia side effects.  However, the FDA has announced that the TIDE study would not be allowed to enroll any additional subjects because of the risks involved with serious Avandia side effects that include heart attacks and strokes.  To date, approximately 1,100 people have been enrolled in the TIDE study.

How the Avandia Side Effects Issue Could Progress

Based on the recent announcement, there is bound to be more controversy as federal officials move towards a decision regarding Avandia’s presence on the market.  Those who helped put a stop to the recruitment to this study cited the unreasonable risks involved, but those who favor Avandia remaining on the market have stated that they need these studies to prove the drug’s overall safety and benefits to those who use it.

While this latest Avandia side effects issue is important, it does not matter to those who have already suffered from serious Avandia side effects.  If this includes you or someone you love, you need to contact the Avandia side effects lawyers at the Phillips National Injury Group today to schedule a free initial consultation.