sutures newsletter

PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY December 2014 | Archived Issues

P and T Approvals, FDA Warnings

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 lenalidomide, duloxetine hydrochloride, alglucosidase alfa and methoxy polyethylene glycol-epoetin beta.


Mark Your Calendar


Grand Rounds

Click here to view a schedule of all upcoming grand rounds.


Educational Schedule

Click the PDF link below to see the Department of Surgery's educational schedule.

Educational Schedule - December 2014 (PDF)


Surgery Scheduling

Click the "read more" for hours and contact information for surgery scheduling.

Share Your News

Know an interesting colleague we should profile? A story we should tell? Submit your ideas, meetings and events for consideration.

Click here to submit your news to Sutures

P and T Approvals, FDA Warnings

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 lenalidomide, duloxetine hydrochloride, alglucosidase alfa and methoxy polyethylene glycol-epoetin beta.

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

FDA: Lenalidomide Poses Increased Risk of DVTs, Other Problems

The FDA said the cancer drug lenalidomide (Revlimid) demonstrated a significantly increased risk of deep vein thrombosis and pulmonary embolism, as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with lenalidomide and dexamethasone therapy.

For more information, click here.

FDA: Suicidal Thoughts More Likely in Younger Patients With Duloxetine Hydrochloride

The FDA said antidepressants, including duloxetine hydrochloride (Cymbalta), increased the risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24, and there was a reduction in risk with antidepressant use in patients 65 and older.

For more information, click here.

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, the FDA said. 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.