Public Citizen Petitions FDA to Ban Avandia, Cites Life-Threatening Toxicity as Top Diabetes Associations Advise Against Use

For Immediate Release

Public Citizen Petitions FDA to Ban Avandia, Cites Life-Threatening Toxicity as Top Diabetes Associations Advise Against Use

Risks Outweigh Benefits of the Diabetes Drug;

WASHINGTON - The Food and Drug Administration (FDA) should
immediately ban the dangerous diabetes drug Avandia because it can
cause death from liver failure and has many other life-threatening
risks that far outweigh its benefits, Public Citizen said in a petition
filed today with the agency.

New research released by Public Citizen about the drug,
used to treat Type 2 diabetes, comes as a working group with
representatives from the American Diabetes Association (ADA) and the
European Association for the Study of Diabetes, unanimously advised
against using Avandia, whose generic name is rosiglitazone, because of
their concerns about the drug's risks. This statement appears in the
newly published issue of Diabetes Care, the ADA's peer-reviewed
medical journal. Despite a significant decrease in its use since
publication of a study linking it to increased risk of heart attacks,
approximately 10,000 prescriptions a day are still filled for this
unacceptably dangerous drug, which is sold by Glaxo-SmithKline.

Public Citizen has identified 14 cases of
Avandia-induced liver failure, including 12 deaths. These cases were
derived from the FDA Adverse Event Reporting System after careful
review of the agency's MedWatch forms, which are submitted to the
agency when adverse drug reactions are suspected.

Liver toxicity is only the most recently noted danger
of Avandia; Public Citizen has encouraged diabetes sufferers to avoid
taking the drug because it increases the risk of heart attack
approximately 40 percent, doubles the risk of heart failure and bone
fractures, and increases the risk of anemia and vision loss from
macular edema, a swelling of the retina caused by fluids accumulating
in the eye. There were 39 times more reports of macular edema per
million prescriptions filled for Avandia than for an older diabetes
drug, glipizide.

Avandia prescriptions fell sharply following a May 2007 study published in The New England Journal of Medicine
connecting the drug with increased heart attack risk. In 2006, the
number of people taking the drug peaked at 13.2 million. Since then,
that number has dropped to 4.6 million for the last full year. This
means that about 10,000 prescriptions a day are still being filled for
this dangerous drug.  

"The scientific consensus against Avandia is
overwhelming," said Dr. Sidney Wolfe, director of Public Citizen's
Health Research Group. "The timing of these findings should give the
FDA the momentum it needs to act swiftly to prevent further needless
deaths and health damage by banning this drug."

Safer, more effective drugs for Type 2 diabetes include
metformin (brand name Glucophage) and glipizide (brand name Glucotrol).
Pioglitazone (sold as Actos), a drug in the same family as Avandia, is
not recommended, as it shares most of Avandia's toxicities - except for
the risk of heart attack - and   the ADA does not number it among the
preferred therapies for most diabetics.

The full petition is available at http://www.citizen.org/publications/release.cfm?ID=7614.

 

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