F.D.A. Internal Reports Recommend Avandia Be Withdrawn From Market

Posted on February 20, 2010 by Craig Cherry

There is a fierce debate going on within the Food and Drug Administration regarding the drug Avandia.  According to the New York Times, recent internal reports from the Food and Drug Administration recommend that Avandia (a drug used to treat Type 2 diabetes) be removed from the market.  The reports indicate that people who use Avandia needlessly suffer heart attacks and heart failure each month and say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month.   Avandia was linked to 304 deaths during the third quarter of 2009.  It is expected that an advisory committee within the FDA will debate the drug further this spring and summer and will then make a final decision regarding the drug and whether or not it should be sold.

Avandia is manufactured by GlaxoSmithKline and was once one of the best-selling drugs in the world.  In 2006 alone, sales were $3.2 billion.

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Eleventh Circuit Affirms Dismissal of Accutane Lawsuit

Posted on June 13, 2009 by Craig Cherry

On June 10, the Eleventh Circuit Court of Appeals affirmed a district court's granting of summary judgment in favor of Hoffman-La Roche, Inc., the manufacturer of the drug Accutane.  The case involved the tragic death of the son of U.S. Rep. Bart Stupak (D-Mich), who was 17 years old when he took his own life.  Laurie Stupak sued Hoffman-La Roche, Inc. alleging the manufacturer was negligent in failing to warn that Accutane (an acne drug) could cause suicide without any premonitory (warning) symptoms.

The package of Accutane that B.J. Stupak was taking did not warn of a risk of suicide without any warning symptoms.  The court ruled, however, that because Hoffman-La Roche, Inc. did not know at the time that patients using Accutane could experience a desire to kill themselves without any warning signs, the drug manufacturer could not be held liable. 

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