The European Medicines Agency (EMEA) has recommended updating the product information for rosiglitazone-containing antidiabetic medicines. Rosiglitazone is available in the European Union as Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin) and Avaglim (rosiglitazone maleate/glimepiride).
During its January 2008 meeting, the Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a scientific opinion recommending the inclusion of a new warning stating that the use of rosiglitazone in patients with ischemic heart disease and/or peripheral arterial disease is not recommended.
The CHMP also adopted an opinion recommending the addition of a new contraindication stating that rosiglitazone must not be used in patients with an acute coronary syndrome, such as angina or some types of myocardial infarction, because the medicine has not been studied in controlled trials in this specific patient group.
Source: http://www.emea.europa.eu/pdfs/human/press/pr/4223208en.pdf
Showing posts with label Rosiglitazone. Show all posts
Showing posts with label Rosiglitazone. Show all posts
Sunday, February 10, 2008
Thursday, August 16, 2007
Thiazolidinediones (Glitazones)
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. These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning.
The strengthened warning advises healthcare 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 healthcare providers to discuss alternative treatments.
Source: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html
The strengthened warning advises healthcare 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 healthcare providers to discuss alternative treatments.
Source: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html
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