Some diabetes drugs may increase heart failure risk
The U.S. Food and Drug Administration announced manufacturers
of certain drugs approved to treat Type 2 diabetes have
agreed to add a stronger warning on the risk of heart
failure. 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 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).
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.