9/10/2007-
Q: What can you tell me about new warnings for some diabetes drugs?
A: The FDA recently announced that it will require manufacturers of certain diabetes drugs to add a stronger warning to their labeling about the risk of heart failure. The information will be included in the form of a “black-box” warning, and it will emphasize that the drugs may cause or worsen heart failure in certain patients and that patients should be monitored closely.
Drugs that are required to have this warning include Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin) and duetact (pioglitazone and glimepiride). These medications are used in conjunction with diet and exercise to improve blood sugar control in adults with Type 2 diabetes.
The drugs involved are known as “glitazones” or “insulin sensitizers.” Unlike other oral anti-diabetic drugs that affect insulin levels, glitazones make the body more sensitive to the action of insulin. The FDA’s review of adverse event reports involving these drugs found cases of significant weight gain and edema (water retention), which may be signs of heart failure.
The new strengthened warning advises health care professionals to observe patients carefully for signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy.
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. People taking these medications should contact their health care providers if they have any questions.
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