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Avandia Class Action Lawsuits Information
Avandia is a diabetes drug in the same class as Rezulin, an
FDA recalled drug in March 2000. The FDA sent a warning letter on July 17, 2001
saying that Avandia has falsely denied serious risk of congestive heart failure,
hepatitis, and liver failure occurring in Avandia users. When Rezulin diabetes
drug was recalled it was very controversial but the FDA claimed they were
waiting to recall it until a safer alternative was found. Avandia was thought to
be safer on the liver, although the FDA only claimed Avandia was only believed
to be safer but still had the risk of causing liver toxicity.
The consumer group Public Citizen never found evidence that Avandia was a safe
alternative. Approved on May 25, 1999, Avandia first had label changes made by
the FDA on February 8, 2001. The Avandia revisions included warnings of cardiac
failure and other cardiac effects, in addition to hepatic risk information. A
February 22, 2001 letter was sent to Avandia manufacturer stating all Avandia
promotional materials must be revised to include the new risks no later than
March 8, 2001, however the manufacturer continued denying the risk existence at
major meetings in addition to minimizing them in certain labeling pieces.
Avandia Side Effects
Avandia side effects can be very dangerous. Depending on the
condition of the individual, including personal risk factors, Avandia side
effects can have a much larger likelihood of occurring in some patients. It is
essential to educate yourself on what medications you are prescribed so that if
suffering Avandia side effects a patient will be able to take the proper
measures in making sure the condition does not worsen.
The Avandia side effects can range from mild to life threatening. Included on
Avandia labeling are the warnings that Avandia side effects can be as serious as
cardiac events, including failure, and hepatic risks. When Avandia was first
approved it was intended to replace the recalled diabetes drug Rezulin as a safe
alternative because regulators did not associate as many Avandia side effects to
it. Public Citizen consumer group never found that diabetes patients would
suffer fewer Avandia side effects but the drug still remains.
More Avandia Information
Avandia lawsuits have resulted because of the serious Avandia
side effects that have been reported. When Rezulin diabetes drug was recalled
Avandia was intended to replace it as a safer alternative, however the consumer
group Public Citizen never recognized Avandia to be a safe alternative. Avandia
lawsuits have resulted because serious side effects as a result of using Avandia
have surfaced, including congestive heart failure, hepatitis, and liver failure.
The FDA has sent letters to Avandia manufacturer regarding the promotional
activities for Avandia. Avandia lawsuits have resulted, because of the serious
Avandia side effects and because Avandia manufacturer minimized the risks
associated with Avandia. In particular, the FDA warned Avandia manufacturer of
the "oral representations denying the existence of serious new risks associated
with Avandia at GSK's promotional exhibit booth" in September 2001. When Avandia
was approved the FDA stated they were not confident of its safety regarding
liver toxicity, just that Avandia appeared to be safer than Rezulin, a factor
that Avandia lawsuits may point out.
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