GlaxoSmithKline Updates Prescribing Information For Avandia In The US

Main Category: Diabetes
Also Included In: Cardiovascular / Cardiology
Article Date: 20 Aug 2007 - 0:00 PDT

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GlaxoSmithKline [NYSE:GSK] today announced that the US Food and Drug Administration (FDA) has approved updated US prescribing information for the thiazolidinediones (TZD) class of medicines used in the treatment of Type 2 diabetes. This approval allows GSK to implement changes in the label for Avandia® (rosiglitazone maleate) as previously committed.

The label will contain a boxed warning, which increases the prominence of an already existing warning for all medicines in the TZD class on the risk of congestive heart failure (CHF), a well known and well characterized risk in this class of medicine. The boxed warning also will note that TZDs are not recommended in patients with symptomatic heart failure, and that initiation of TZDs in patients with established NYHA Class III or IV heart failure is contraindicated. The Contraindications have also been updated regarding initiation of Avandia in patients with NYHA Class III or IV heart failure.

Information about CHF has been included in the prescribing information for Avandia since 1999, when the medicine was first approved by the US Food and Drug Administration. Since 2001, US prescribing information for Avandia has included a warning for "Cardiac Failure and Other Cardiac Effects" with a recommendation that use of Avandia be discontinued in patients if their cardiac status worsened.

The changes related to CHF are being implemented on the labels of all rosiglitazone containing products: Avandia, Avandamet® (rosiglitazone maleate and metformin hydrochloride) and Avandaryl™ (rosiglitazone maleate and glimepiride).

More than 4.5 million Americans suffer from CHF, which also is one of the most common complications of type 2 diabetes. CHF is a condition in which the heart cannot pump enough blood to the body's other organs, which can result in fluid retention, or edema. It is also well known that TZDs can cause some fluid retention, which can lead to or worsen CHF.

The change in CHF labeling is not related to the FDA's review of additional data on the risk of myocardial ischemic events, which include heart attack. The FDA held an Advisory Committee meeting on July 30th to review that data.

Important Safety Information for Avandia® (rosiglitazone maleate)

Avandia, along with diet and exercise, helps improve blood sugar control. It may be taken alone or with other diabetes medicines. For some people taking Avandia, possible side effects include heart failure or other heart problems. Further information regarding potential heart-related risks is currently under review by the FDA. Talk to your doctor as FDA has made information on potential heart-related risks available to physicians on its website at http://www.fda.gov. Tell your doctor if you have heart problems or heart failure. Avandia can cause your body to keep extra fluid, which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. If you have swelling or fluid retention, shortness of breath or trouble breathing, an unusually rapid increase in weight, or unusual tiredness while taking Avandia, call your doctor right away. You should not take Avandia if you have liver problems. Blood tests should be used to check for liver problems before starting and while taking Avandia. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, stomach problems, dark urine or yellowing of skin while taking Avandia. Tell your doctor about all of the medicines you are taking. If you are taking Avandia with another diabetes medicine that lowers blood sugar, you may be at increased risk for low blood sugar. Ask your doctor whether you need to lower the dose of your other diabetes medicine. Avandia may increase your risk of pregnancy. Talk to your doctor before taking Avandia if you could become pregnant or if you are pregnant. If you are nursing, you should not take Avandia . Talk to your doctor for advice on how to keep your bones healthy. More fractures, usually in the upper arm, hand, or foot, have been seen in women taking Avandia. Your doctor should check your eyes regularly. Very rarely, some people have experienced vision changes due to swelling in the back of the eye while taking Avandia.

GlaxoSmithKline one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at http://www.gsk.com.