FDA: Manufacturer of Avandia Strengthens Warning on Heart Failure Risk
August 14, 2007
Media Inquiries: Susan Cruzan, 301-827-6242; Consumer Inquiries: 888-INFO-FDA
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 glimepiride). 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.
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).
If you or a loved one has suffered
cardiac complications after ingesting Avandia, you deserve the guidance of a
knowledgeable drug attorney. Get a free case review by filling out the form
below.
see also:
Weakens Bones
Diabetes Drug Avandia Could Weaken Bones--Get a Free Legal ReviewStudy: Type 2 Diabetes Med Avandia May Contribute to Fracture of Bones
Updated Study, 7.12.07
Latest News on Avandia: German Study Adds More Reasons to Avoid itLatest Study in the News: Avandia May Worsen Complications of Diabetes
News & Warnings
Avandia Breaking News: Glaxo Warned in 2001 about Misleading MarketingBloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001
