Skip to main content

GSK adds CHF boxed warning on Avandia label

GSK adds CHF boxed warning on Avandia label


Friday, August 17, 2007 10:00 IST 
Philadelphia, Pennsylvania

GlaxoSmithKline 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). 
Labels:

Comments

Post a Comment

Popular posts from this blog

Indian government outlines policies on drug pricing to favor poorer patients, and increase clinical trials

The Indian government is looking to review the existing drug price control measures in order to make medicines more affordable in the country, and at increasing the number of clinical trials taking place in the country, reports The Pharma Letter's India correspondent. In a parallel move, the Health Ministry is also preparing a framework for public private partnership to tackle the menace of non-communicable diseases in the country, In a move that could potentially result in affordable Medicare and health security moving to a larger section of the population, the government is considering a rash of policy measures in favor of poor patients. Talks are also on in government circles to abolish clinical trials on proven drugs that have been approved and marketed for at least two years in the European Union, United States, UK, Australia, Canada and Japan. A draft proposal in this regard has been prepared by the Health Ministry. If instituted, it would reduce the time taken to introduce n...
Post a Comment
Read more

The polypill: Medicine's magic bullet

The capsule costs pennies, contains a simple cocktail of medicines, and halves the number of strokes and heart attacks. Doctors want to hand it out in the first mass medication for the middle-aged in Britain. So why are the big drug companies so uninterested? The magic bullet, containing five medicines in a single capsule, sharply reduced cholesterol and blood pressure levels and has the potential to "halve cardiovascular events in average middle-aged individuals", the researchers say. The finding is a major boost for a medication with huge potential against the worldwide epidemic of heart disease and stroke. Doctors say that, if further trials prove successful, all men aged over 50 and women aged over 60 should be offered the pill in what would be the first example of mass medication for the middle-aged in Britain. Yet no Western pharmaceutical company has shown interest in developing the so-called polypill because it does not promise big profits. It would sell for pennies b...
Post a Comment
Read more

Registration of herbal trials in CTRI is not mandatory

A trial patient visited the site complaining breathlessness and tachycardia. The investigator advised hospitalization but as subject could not afford the expenses, he refused for admission. Is this an SAE because investigator advised hospitalization? G Praveen Kumar. If the patient was not hospitalized, it does not fall into SAE criteria of hospitalization. However, it appears from your mail that the PI felt that the event was serious enough to admit the subject for treatment. This makes it an “important medical event." As per ICH E2A such event also are considered serious. See the ICH E2A excerpt below: Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the defin...
Post a Comment
Read more