Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

ADA Avandia recommendations

Executive Summary

The American Diabetes Association is not changing its treatment guidelines, but is urging physicians to exercise caution in prescribing thiazolidinediones, particularly GlaxoSmithKline's Avandia (rosiglitazone). Treatment with Avandia or Takeda's Actos (pioglitazone) remains as a second-line option for diabetics unable to control their hemoglobin levels with metformin on ADA's treatment algorithm, but recent safety concerns with TZDs "should prompt clinicians to consider more carefully whether to use this class of drugs vs. insulin or sulfonylureas as the second step in the algorithm," the group advises. ADA's consensus statement, updated Nov. 27, notes that "in addition to the concern raised regarding the potential risk of myocardial infarction with rosiglitazone, the previously recognized risk of fluid retention and resultant CHF, which applies to both pioglitazone and rosiglitazone, has now been quantified as an approximately two-fold increase." The emerging safety signals have led FDA to add a "black box" warning about the risk of congestive heart failure to TZD class labeling, and more recently a "boxed warning" about a potential risk for heart attack to the Avandia label (1"The Pink Sheet" Nov. 19, 2007, p. 3)...

You may also be interested in...



Avandia Adds Black Box For Heart Attack Risk; Actos Launches Ads

FDA has unveiled the much-anticipated labeling change for GlaxoSmithKline's type 2 diabetes therapy Avandia, but is deeming the information about rosiglitzone's cardiovascular risk "inconclusive" and is asking the sponsor to undertake a long-term outcomes study to address outstanding safety questions

Patient-Focused Drug Development Events May Be Giving Way To Small, Private Meetings With FDA

Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.

Who Can Sign US FDA EUAs? Now Center Directors And Their Deputies

Agency policy now allows several others along with the FDA chief scientist to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.

Latest News
See All
UsernamePublicRestriction

Register

PS049063

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel