corner
Healthy Skepticism
Join us to help reduce harm from misleading health information.
Increase font size   Decrease font size   Print-friendly view   Print
Register Log in

Healthy Skepticism Library item: 11201

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Diabetes drugs Avandia and Actos to include new heart failure warnings
Associated Press 2007 Aug 14
http://www.iht.com/articles/ap/2007/08/14/america/NA-MED-US-Diabetes-Heart-Failure.php


Full text:

WASHINGTON: The diabetes drugs Avandia and Actos will be labeled with severe warnings about a risk of heart failure to some patients, U.S. health officials said Tuesday.

The makers of the drugs, GlaxoSmithKline Plc and Takeda Pharmaceutical Company Ltd., have agreed to add the “black-box” warnings, the Food and Drug Administration said. The warnings, the most severe that prescription drugs can bear, stress the medicines may cause or worsen heart failure and that patients should be closely monitored.

The warnings also apply to combination drugs that include the active ingredients in Avandia, made by Glaxo, or Takeda’s Actos. The drugs help patients with Type 2 diabetes control their blood sugar levels.

The warnings, which the FDA said in June it would seek, are separate from concerns that Avandia also raises the risk of heart attack. FDA advisers said last month the risk appeared real but that the evidence was not conclusive enough to merit pulling Avandia from the market. They did recommend Avandia’s label be updated to include information on that risk. The FDA said it was continuing its review of the issue.

Separately, an FDA review of reports of side effects in patients taking either Avandia or Actos found cases of significant weight gain and build up of fluids, both of which are warning signs of heart failure, the agency said.

On the Net:

FDA Avandia information: http://www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm

FDA Actos information: http://www.fda.gov/cder/drug/infopage/pioglitazone/default.htm

 

  Healthy Skepticism on RSS   Healthy Skepticism on Facebook   Healthy Skepticism on Twitter

Please
Click to Register

(read more)

then
Click to Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts


If there is something you don't like, please tell us. If you like our work, please tell others.

Email a Friend