Cedars-Sinai Medical Center

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A BI-WEEKLY PUBLICATION FROM THE CEDARS-SINAI CHIEF OF STAFF June 25, 2010 Issue | Archived Issues

Pharmacy Focus

Boxed warning added to WinRho®

Possible increased risk of fractures with proton pump inhibitors

FDA reports cases of severe liver injury with orlistat

» Read more


Physician News

Asher Kimchi, M.D., has been elected as a Fellow of the International Academy of Cardiovascular Sciences ...

Peter J. Julien, M.D., received a California State Assembly Resolution ...

Michael Lill, M.D., was appointed to a term as a Cancer Liaison Physician ...

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Meetings and Events

Atrial Fibrillation Forum, June 29

Sand N' Snore, July 16

Vasculitis: Current Concepts and Best Practices, July 31

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Web/VS Tip of the Week

ECG viewing enhancement

You can view two ECGs simultaneously in Web/VS for comparison purposes.

» Read more

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Pharmacy Focus

Boxed warning added to WinRho®

A boxed warning has been added to WinRho®, notifying healthcare professionals that cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients receiving this medication for immune thrombocytopenic purpura. IVH can lead to clinically compromising anemia and multi-system organ failure. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients over 65 with co-morbid conditions. WinRho® therapy requires patient monitoring in a healthcare setting for at least eight hours after administration, as outlined in the prescribing information.

Possible increased risk of fractures with proton pump inhibitors

The U.S. Food and Drug Administration notified healthcare professionals and patients of revisions to the prescription and over-the-counter labels for proton pump inhibitors (PPIs), to include new safety information about a possible increased risk of hip, wrist and spine fractures associated with the use of these medications.

A review of epidemiological studies found that patients at greatest risk for these fractures received high, prescription doses of PPIs, or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture was primarily observed in this age group. The FDA recommends that healthcare professionals should consider whether lower doses or shorter duration of therapy would adequately treat the patient's condition when prescribing PPIs.

FDA reports cases of severe liver injury with orlistat

The FDA notified healthcare professionals and patients of revisions to the labeling information on orlistat to include warnings about cases of rare but severe liver injury associated with the use of this medication. Xenical® and Alli® are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter. This new safety information will apply to both forms of orlistat.

Healthcare professionals should weigh the benefits of weight-loss with the potential risks associated with these medications before prescribing or recommending them. Patients should stop the use of orlistat and contact their healthcare professional if they develop the signs and symptoms of liver injury, including itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite. Orlistat is a nonformulary medication at Cedars Sinai.