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FDA Dismisses Results of Avandia Side Effects Study

Avandia is a type 2 diabetes drug that is manufactured by GlaxoSmithKline, and for years it dominated the market in this regard because of the early promise it showed in helping people control their constant symptoms.  However, a large number of reports of serious Avandia side effects eventually began to surface, and as a result Avandia side effects lawyers around the country and the FDA got involved with holding GlaxoSmithKline accountable for releasing Avandia onto the marketplace. One of the steps that’s being taken today and tomorrow is a discussion by a federal panel of experts regarding whether or not Avandia should remain on the market given its purported utility versus the potential for Avandia side effects.  In furtherance of this discussion, studies will be reviewed to dissect the statistics regarding the probability of someone developing Avandia side effects.

The RECORD Study Regarding Avandia Side Effects

GlaxoSmithKline has been depending on a study regarding Avandia side effects known as the RECORD study.  This study tracked more than 4,400 patients, some of whom were given Avandia and others who were given other diabetes medications.  The results of the RECORD study concluded that people are no more likely to develop Avandia side effects that include heart attacks and strokes than they are if they take other medications.

The FDA’s Reaction to the Avandia Side Effects Study

The FDA also reviewed the results of the RECORD study, and the agency did nothing short of blast the results.  The agency stated that the following problems existed with RECORD:
  1. Researchers sloppily compiled the data in the study
  2. Researchers failed to follow up on reports of Avandia side effects
  3. The entire study was biased at its foundation
These are extremely strong criticisms, and they could be very persuasive in regards to the ultimate decision that’s made sometime this week in terms of Avandia’s place on the market.

How an Avandia Side Effects Lawyer Can Help

Regardless of what’s decided by the panel in regards to Avandia, many people have already suffered greatly from Avandia side effects.  If this includes you or someone you love, you need to take action to protect your legal rights.  Contact the Avandia side effects lawyers at Phillips & Associates today to schedule a free initial consultation.