Navigation Links
FDA Issues Safety Alert on Avandia

ROCKVILLE, Md., May 21, 2007-The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.

Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

FDA's analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.

"FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In th is case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."

Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients tr eated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.

Avandia is manufactured by GlaxoSmithKline, which is based in Research Triangle Park, N.C.

####

Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


'"/>




Related medicine technology :

1. Vicals Vaxfectin Adjuvant With Needle-free Delivery Enhances DNA Vaccine Performance; Yields Antibody Responses Comparable to Electroporation Without Tolerability Issues
2. Managing Preanalytical Processes for Patient Safety
3. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
4. New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV
5. Cytogen Presents Phase 1 Data Showing Promising Antitumor Activity and Safety Profile of Quadramet at International Myeloma Workshop
6. New Proof of Genisteins Efficacy and Safety for Osteopenia and Osteoporosis Published in Annals of Internal Medicine
7. First Phase II Short-Term Study on Dapagliflozin Shows Results on Safety, Tolerability and Glycemic Markers in Subjects With Type 2 Diabetes
8. Phase IIIb Clinical Data Validate the Overall and Cardiovascular Safety Profile of Cycloset (A Quick Release Formulation of Bromocriptine Mesylate) in Patients with Type 2 Diabetes
9. Neurologix Announces Publication of Landmark Gene Therapy Study Demonstrating Safety and Statistically Significant Improvement in Patients With Advanced Parkinsons Disease
10. Next Safety, Inc.s Innovative Drug Delivery System Will Replace Cigarettes and Significantly Advance Pulmonary Medication Delivery
11. Enbrel Safety Data for up to Eight Years in Patients with Juvenile Rheumatoid Arthritis Being Presented at EULAR
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... 27, 2016 According to the ... is driving ambulatory blood pressure monitoring system market growth. ... their ability to respond to different pressure rates, leading ... lead to various cardiovascular disorders such as heart failure, ... diseases are growing in prevalence each year. WHO estimates ...
(Date:5/27/2016)... , May 27, 2016 ... innovative biopharma company focused on the highly lucrative ... a substantial pipeline of potential first-in-class or best-in-class ... are in development with strategic partners. HCM,s profitable ... fast-growing domestic market. We expect progress of the ...
(Date:5/27/2016)... 2016 Kitov Pharmaceuticals ... on late-stage drug development, today announced the completion ... pivotal batches required for registration of KIT-302 with ... follows Kitov,s announcement in December 2015, ... its primary efficacy endpoint. "We are ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... , ... Connor Sports, through its Connor Cares initiative, will continue ... Catchings Legacy Tour that will commemorate the Indiana Fever legend’s hall-of-fame career and ... forms and levels of the game, Connor Sports has committed to a significantly increased ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... a significant negative impact on long-term patient survival, reports a team of UPMC ... online this week in the Journal of Thoracic and Cardiovascular Surgery, provide critical ...
(Date:5/26/2016)... ... 2016 , ... Catalent Pharma Solutions, the leading global provider ... global clinical supply services, today announced two key appointments and the opening of ... strategic growth plans in the Asia Pacific region. , Howard Kim has joined ...
(Date:5/26/2016)... , ... May 26, 2016 , ... In an effort to provide hair restoration information ... both Snapchat users and those who do not use the app. Dr. Mohebi, the founder ... page, Dr. Mohebi Live . , Dr. Mohebi says, “The positive response to ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... comprehensive treatment for eating disorders, is opening a brand new child and adolescent ... ages 8-17 and their families with even more specialized eating disorder treatment and ...
Breaking Medicine News(10 mins):