 The U.S. Food and Drug Administration
today announced manufacturers of certain drugs approved to treat
Type 2 diabetes 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.After a review of postmarketing
adverse event reports, FDA 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. This class
includes 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."
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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.
FDA's review of Avandia and possible increased risk of heart
attacks is ongoing. 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
[Text copied
from U.S. Food and Drug Administration
news release] |
