Navigation Links
Avandia Label to Get Heart-Attack Warning
Date:11/14/2007

FDA takes action on diabetes drug although evidence is inconclusive

WEDNESDAY, Nov. 14 (HealthDay News) -- The popular diabetes drug Avandia -- which has been linked to the risk of heart failure and, more recently, heart attack -- will carry a revised "black box" warning noting the heart attack risk, even though the research on heart attack is inconclusive, U.S. officials said Wednesday.

GlaxoSmithKline, the maker of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add the new warning to the existing black box warning on the drug's label, according to U.S. Food and Drug Administration officials.

"We are announcing an update to the existing box warning on Avandia," Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research, said during a midday teleconference. "A black box is the strongest form of warning, and we are adding another warning to that black box."

Despite the revised warning label, the FDA said it isn't seeking to have the drug withdrawn from the market, because the evidence for the increased heart-attack risk is not conclusive.

"We are keeping Avandia on the market, because we have concluded there isn't enough evidence to indicate that the risk of heart attack is higher for Avandia than other type 2 diabetes treatments," Woodcock said.

Woodcock said the FDA has asked GlaxoSmithKline to conduct a long-term study comparing Avandia with other type 2 diabetes drugs. The trial will most likely start in a year, and full results won't be available until 2014.

The new labeling follows recommendations made by the FDA's Endocrine and Metabolic Advisory Committee and Drug Safety and Risk Management Advisory Committee. In July, the committees recommended keeping Avandia on the market, pending a review of additional data. The committees also said the drug's label should carry a warning of the potential for increased risk of heart attacks.

Controversy over Avandia started in May, when a study published in the New England Journal of Medicine, found a 43 percent increased risk of heart attack among patients taking the drug. The study was carried out by Dr. Steven E. Nissen, chairman of the Cleveland Clinic's department of cardiovascular medicine, and his colleague Kathy Wolski. Nissen said he uncovered the risk after poring over data from 42 studies of Avandia.

Both the FDA and GlaxoSmithKline continue to say that the evidence for the risk of heart attack with Avandia is inconclusive.

"Avandia remains a safe and effective medicine for most patients with type 2 diabetes when used appropriately," Dr. Ronald Krall, GlaxoSmithKline's chief medical officer, said in a prepared statement. "Given the severity of this disease and the importance of Avandia in helping patients manage their diabetes, we will continue to work with the FDA to conduct more studies about the safety and benefits of our medicine."

The new warning states: "A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive."

The FDA is advising people with type 2 diabetes who have heart disease or are at risk of a heart attack to discuss their use of Avandia with their doctor to evaluate treatment options. The agency is also advising doctors to monitor patients who have cardiac risk and are taking the drug.

In August, Avandia's warning label was changed, to state that the drug and others in its class may worsen heart failure -- a condition in which the heart does not adequately pump blood -- in some patients. The association between Avandia and increased risk for heart failure has been known since 1999, when the drug was first approved.

Woodcock noted that Avandia and the other oral anti-diabetes drugs, called thiazolidinediones, have not been shown to prevent cardiovascular risk as a byproduct of reducing blood sugar.

In light of this, the FDA is asking all manufacturers of approved oral anti-diabetes drugs to include a statement on their label saying that there is no data that the drugs have the ability to protect the heart.

More information

For more on diabetes drugs, visit the U.S. Food and Drug Administration.



SOURCES: Nov. 14, 2007, teleconference with Janet Woodcock, M.D., acting director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Nov. 14, 2007, news release, GlaxoSmithKline, Philadelphia


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Diabetes Drug Avandia Boosts Heart Risks: Study
2. GSK Revises US Labeling for Avandia(R)
3. Prescription labels geared toward pharmacies, not patients
4. FDA: Use the Nutrition Facts Label to Make Healthy Food Choices
5. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
6. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
7. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
8. Lilly Announces Updates to the Zyprexa and Symbyax U.S. Labels
9. IOM workshop on less confusing drug labeling, Oct. 12
10. FDA Expands VELCADE(R) (Bortezomib) for Injection Label for Patients with Multiple Myeloma
11. National Patient Advocate Foundation (NPAF) Statement Regarding New FDA Label on Erythropoietin Stimulating Agents (ESAs)
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Avandia Label to Get Heart-Attack Warning
(Date:2/23/2017)... ... ... Dr. David Mahon leads Siena Dental, a comprehensive dental practice located at ... Top Patient Rated Henderson Dentist by Find Local Doctors earlier this year. ... dentists who have earned high ratings and superior patient reviews from multiple credible sources. ...
(Date:2/23/2017)... ... , ... ERT, a global data and technology company that ... leading clinical development service provider, has selected ERT’s Trial Oversight suite as its ... to an array of circumstances including the use of multiple data capture modalities ...
(Date:2/23/2017)... , ... February 23, 2017 , ... ... publication and community for those in the fight against cancer, has produced a ... their success. HRA will release top-line findings in a webinar, Defining Compassionate ...
(Date:2/23/2017)... ... (PRWEB) February ... for the nation to come together to combine its favorite ... with its favorite fruit – apples! To celebrate National Nutrition ... join the “Apple Madness” bracket tournament – a five-week, five-round ...
(Date:2/23/2017)... ... February 23, 2017 , ... Top cosmetic and periodontal dentist Dr. Mahnaz ... a new Indiegogo campaign . Individuals are now able to contribute to the ... area, either as a participating patient or through an Indiegogo donation. The entirety of ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... Feb. 23, 2017 AcelRx Pharmaceuticals, Inc. ... the development and commercialization of innovative therapies for ... it will release fourth quarter and yearly financial ... 2017. AcelRx management will host an investment-community conference ... Pacific Time) on March 2 nd 2017 ...
(Date:2/23/2017)... ... has announced the addition of the "Global Antifungal Drugs Market Analysis ... The Global Antifungal Drugs Market is poised to grow ... approximately $12.8 billion by 2025. This industry report ... global as well as regional levels presented in the research scope. The ...
(Date:2/23/2017)... 2017 The top three players ... Healthcare, Koninklijke Philips N.V., and Schiller. Collectively, these companies ... market in 2015. Strong product portfolio and a monumental ... be aiding these players remain leaders in the fragmented ... in the global market are likely to focus on ...
Breaking Medicine Technology: