Cedars-Sinai Medical Center

medical staff pulse newsletter

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A BI-WEEKLY PUBLICATION FROM THE CEDARS-SINAI CHIEF OF STAFF Dec. 19, 2014 | Archived Issues

P and T Approvals, FDA Warnings About Alglucosidase Alfa, Methoxy Polyethylene Glycol-Epoetin Beta

Pharmacy Focus

See highlights of the Oct. 7 meeting of the Pharmacy and Therapeutics Committee. Also, the U.S. Food and Drug Administration has issued warnings about alglucosidase alfa and methoxy polyethylene glycol-epoetin beta.

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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 - December 2014 (PDF)


Milestones

Do you know of a significant event in the life of a medical staff member? Please let us know, and we'll post these milestones in Medical Staff Pulse. Also, feel free to submit comments on milestones, and we'll post the comments in the next issue. Click here to email us your milestones and comments.

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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

P and T Approvals, FDA Warnings About Alglucosidase Alfa, Methoxy Polyethylene Glycol-Epoetin Beta

Pharmacy Focus

Highlights of the Oct. 7 meeting of the Pharmacy and Therapeutics Committee are summarized in the PDF link below. Also, the U.S. Food and Drug Administration has issued warnings about alglucosidase alfa and methoxy polyethylene glycol-epoetin beta.

P and T Committee Approvals - Oct. 7, 2014 (PDF)

FDA: Some Patients Have Life-Threatening Reactions to Alglucosidase Alfa

Life-threatening anaphylactic reactions and severe hypersensitivity reactions have occurred in some patients during and after alglucosidase alfa (Lumizyme) infusions, according to the FDA. Infantile-onset Pompe disease patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload, and they require additional monitoring.

For more information, click here.

FDA: Methoxy Polyethylene Glycol-Epoetin Beta, Other ESAs Increase Risk of Death, Stroke

The FDA said that in controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions and stroke when administered methoxy polyethylene glycol-epoetin beta (Mircera) or other erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose or dosing strategy that does not increase these risks. Use the lowest Mircera dose sufficient to reduce the need for red blood cell transfusions, the FDA said. Mircera is not indicated or recommended for the treatment of anemia due to cancer chemotherapy. A dose-ranging study of Mircera was terminated early because of more deaths among patients receiving Mircera than those receiving another ESA.

For more information, click here.