Medical Staff Pulse Newsletter

Recognition for Honjo, Reich, Slattery, Azizzadeh, Steiner

Physician News

Tomoyuki Honjo, MD, PhD, has received honors for his work on a vaccine to treat aortic aneurysms; Heidi Reich, MD, has won a Sports Spectacular Endowed Fellowship; William H. Slattery, MD, and Babak Azizzadeh, MD, have completed a book on the facial nerve; and Jerrold H. Steiner, MD, has been honored by the Tower Cancer Research Foundation.

» Read more

Meetings and Events

Grand Rounds

Click here to view upcoming grand rounds.

Upcoming CME Conferences

Click below to view a complete list of all scheduled Continuing Medical Education conferences.

CME Newsletter - November 2013 (PDF)

Share Your News

Won any awards or had an article accepted for publication? Share your news about professional achievements and other items of interest.

Click here to share your news

FDA Lessens Restrictions on Rosiglitazone Drugs

Pharmacy Focus

The U.S. Food and Drug Administration has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl and generics, do not show an increased risk of heart attack compared to the standard Type 2 diabetes medicines metformin and sulfonylurea. As a result, FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010.

Also, a summary of FDA boxed warnings has been issued.

The decision on rosiglitazone medicines is based on FDA review of data from a large, long-term clinical trial and is supported by a comprehensive, expert re-evaluation of the data conducted by the Duke Clinical Research Institute.

Previous data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart attack, so the FDA required a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program. The Rosiglitazone REMS program restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks.

Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines remains, in light of the new re-evaluation, the FDA's concern is substantially reduced, and the rosiglitazone REMS program requirements will be modified.

Learn more at this FDA Web page.

FDA Boxed Warnings Summarized

A summary of boxed warnings from the FDA has been issued. Click the PDF link below to see the summary.

FDA Boxed Warning Summary (PDF)