PHILADELPHIA, Aug. 14 GlaxoSmithKline(NYSE: GSK) today announced that the US Food and Drug Administration (FDA) hasapproved updated US prescribing information for the thiazolidinediones (TZD)class of medicines used in the treatment of Type 2 diabetes. This approvalallows GSK to implement changes in the label for Avandia(R) (rosiglitazonemaleate) as previously committed.
The label will contain a boxed warning, which increases the prominence ofan already existing warning for all medicines in the TZD class on the risk ofcongestive heart failure (CHF), a well known and well characterized risk inthis class of medicine. The boxed warning also will note that TZDs are notrecommended in patients with symptomatic heart failure, and that initiation ofTZDs in patients with established NYHA Class III or IV heart failure iscontraindicated. The Contraindications have also been updated regardinginitiation of Avandia in patients with NYHA Class III or IV heart failure.
Information about CHF has been included in the prescribing information forAvandia since 1999, when the medicine was first approved by the US Food andDrug Administration. Since 2001, US prescribing information for Avandia hasincluded a warning for "Cardiac Failure and Other Cardiac Effects" with arecommendation that use of Avandia be discontinued in patients if theircardiac status worsened.
The changes related to CHF are being implemented on the labels of allrosiglitazone-containing products: Avandia, Avandamet(R) (rosiglitazonemaleate and metformin hydrochloride) and Avandaryl(TM) (rosiglitazone maleateand glimepiride).
More than 4.5 million Americans suffer from CHF, which also is one of themost common complications of type 2 diabetes. CHF is a condition in which theheart cannot pump enough blood to the body's other organs, which can result influid retention, or edema. It is also well known that TZDs can cause somefluid retention, which can lead to or worsen CHF.
The change in CHF labeling is not related to the FDA's review ofadditional data on the risk of myocardial ischemic events, which include heartattack. The FDA held an Advisory Committee meeting on July 30th to review thatdata.
Important Safety Information for Avandia(R) (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 takingAvandia, possible side effects include heart failure or other heart problems.Further information regarding potential heart-related risks is currently underreview by the FDA. Talk to your doctor as FDA has made information onpotential heart-related risks available to physicians on its website athttp://www.fda.gov. Tell your doctor if you have heart problems or heartfailure. Avandia can cause your body to keep extra fluid, which leads toswelling and weight gain. Extra body fluid can make some heart problems worseor lead to heart failure. If you have swelling or fluid retention, shortnessof breath or trouble breathing, an unusually rapid increase in weight, orunusual tiredness while taking Avandia, call your doctor right away. Youshould not take Avandia if you have liver problems. Blood tests should be usedto check for liver problems before starting and while taking Avandia. Tellyour doctor if you have liver disease, or if you experience unexplainedtiredness, stomach problems, dark urine or yellowing of skin while takingAvandia. Tell your doctor about all of the medicines you are taking. If youare taking Avandia with another diabetes medicine that lowers blood sugar, youmay be at increased risk for low blood sugar. Ask your doctor whether you needto lower the dose of your other diabetes medicine. Avandia may increase yourrisk of pregnancy. Talk to your doctor before taking Avandia if you couldbecome pregnant or if you are pregnant. If you