Current News

FDA Drug Safety Communication: Ongoing safety review of Benicar and cardiovascular events

June 11, 2010

The U.S. Food and Drug Administration (FDA) is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan) had a higher rate of death from a cardiovascular cause compared to patients taking a placebo.

 

EDITOR'S COMMENTARY: The Patient Safety Exchange Editor would like to emphasize that readers should carefully read the FDA data summary on the link to understand how few events occurred and the distribution between fatal and non-fatal MACE events as well as the total number of MACE events in both trials.

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FDA Statement on Thyrogen

May 26, 2010

As a consequence of previous concerns raised regarding contamination resulting from particulate material in Thyrogen, the FDA and Genzyme have entered into a legal settlement which will limit the availability of a drug used in the treatment and diagnostic of thyroid cancer, Thyrogen

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What's New
Commentary on February 19 New York Times article on Avandia

 

Potential Thyrogen Contamination

 

Pancreatitis Now An Issue for DPP-4 Inhibitors

 

Commentary on July 19 New York Times article on glucose monitor accuracy

 

AACE Expands Interactions with FDA

 

AACE and the FDA

 

Featured Case Study:
A summer misadventure; patient safety issues during vacations because of the overconfidence of the patient.
A 49 y/o drenched male with DM1 of 22 years duration was brought to the emergency department by his wife, who was also drenched. She saw him fall out of his 14 foot boat, into the water when he stood up to land a fish he caught ...
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Featured Case Study:
Too Much of a Good Thing: Thyroid Cancer Suppressive Therapy and Atrial Fibrillation
A 63-year-old man with a distant history of thyroid cancer presented to the emergency department with complaints of chest pain, palpitations and shortness of breath. He had been losing weight over the last year, which he attributed to chemotherapy ...
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Disclaimer:
This site is for informational purposes only. For issues of an individual clinical nature please consult your physician, as medical advice will not be provided through this site. Articles and opinions expressed on the exchange do not necessarily represent the policies and/or opinions of the American Association of Clinical Endocrinologists.

 

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