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Senior Citizen Health & Medicine
Diabetes Drugs to Strengthen Warning of Heart
Failure Risk, Says FDA
Included drugs: Avandia, Actos, Avandary, Avandamet
and Duetact
Aug. 16, 2007 - After a review of adverse events
reported for drugs approved to treat Type 2 diabetes, the Food and Drug
Administration has determined that an updated label with a “boxed
warning” on the risks of heart failure was needed for the entire
thiazolidinedione class of antidiabetic drugs, which includes Avandia,
Actos, Avandary, Avandamet and Duetact.
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The FDA said yesterday the manufacturers have
agreed to add a stronger warning on the risk of heart failure, a
condition that occurs when the heart does not adequately pump blood. The
information will be included in the form of a "boxed" warning—FDA's
strongest form of a warning. The upgraded warning emphasizes that the
drugs may cause or worsen heart failure in certain patients.
The FDA's news release noted that the “review of
Avandia and possible increased risk of heart attacks is ongoing.”
Drugs included are:
● Avandia (rosiglitazone),
● Actos (pioglitazone)
● Avandaryl (rosiglitazone and glimepiride),
● Avandamet (rosiglitazone and metformin), and
● Duetact (pioglitazone and glimepride).
These drugs are used in conjunction with diet and
exercise, to improve blood sugar control in adults with type 2
(non-insulin-dependent) diabetes. FDA had asked the drug's
manufacturers, GlaxoSmithKline and Takeda, to address these concerns.
"Under FDA's postmarketing surveillance program, we
carefully monitor new safety information for marketed drugs and take
appropriate action when necessary to inform patients and health care
providers of new information," said Steven Galson, M.D., M.P.H.,
director of FDA's Center for Drug Evaluation and Research.
"This new boxed warning addresses FDA's concerns
that despite the warnings and information already listed in the drug
labels, these drugs are still being prescribed to patients without
careful monitoring for signs of heart failure."
FDA's review of adverse event reports found cases
of significant weight gain and edema—warning signs of heart failure. In
some reports, FDA noted, continuation of therapy has been associated
with poor outcomes, including death.
The strengthened warning advises health care
professionals to observe patients carefully for the signs and symptoms
of heart failure, including excessive, rapid weight gain, shortness of
breath, and edema after starting drug therapy.
Patients with these symptoms who then develop heart
failure should receive appropriate management of the heart failure and
use of the drug should be reconsidered. People who have questions should
contact their health care providers to discuss alternative treatments.
The warning also states that these drugs should not
be used by people with serious or severe heart failure who have marked
limits on their activity and who are comfortable only at rest or who are
confined to bed or a chair.
On July 30, 2007, FDA's Endocrine and Metabolic
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee recommended that Avandia continue to be marketed, and further
recommended that information be added to the labeling for risk of heart
attacks (ischemic risks).
For more information, visit:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl)
Information
Pioglitazone HCl (marketed as Actos and Duetact) Information
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Controversy over Diabetes
Drug - Avandia
Diabetes, a
major chronic disease among senior citizens, is found in
about 1 out of 5
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Sen. Grassley Says FDA Knew Dangers of Avandia,
Wants Faster Action
Ranking Senate Finance Committee members says there
should already be ‘black box’ warning
May 25, 2007 –
Read more...
Finding Avandia Heart Risk Underscores Need for
Urgent Drug Safety Reform
Consumers Union urges House pass strong drug safety
reforms
May 23, 2007 -
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Senate Committee Wants Answers About Avandia,
Company Defends Record
Committee leaders send letters to FDA and
GlaxoSmithKline
May 22, 2007 –
Read more...
Avandia Drug Maker Disagrees with Study Saying the
Diabetes Drug Increases Heart Attacks, Deaths
GlaxoSmithKline says it's “highly effective”
treatment for type 2 diabetes
May 22, 2007 –
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Major Heart, Diabetes Groups Urge Caution in Wake of
Avandia Warning
Study raises concerns; Groups advise patients with
diabetes to talk to their doctor
May 22, 2007 –
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Finding of
Increased Heart Attack, Death in Diabetes Patients from Avandia (rosiglitazone)
Sparks FDA Alert
FDA issues immediate alert on the drug marketed as
Avandia.
May 21, 2007 –
Read More...
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