Cedars-Sinai Medical Center

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A BI-WEEKLY PUBLICATION FROM THE CEDARS-SINAI CHIEF OF STAFF Dec. 3, 2010 Issue | Archived Issues

Jan. 6 Reception for New OB/Gyn Chair

A welcome reception is planned for Sarah J. Kilpatrick, M.D., Ph.D., the new chair of the Department of Obstetrics and Gynecology. The event will be held on Thursday, Jan. 6, from 2 to 5 p.m. in Harvey Morse Auditorium, and medical staff members are invited to attend.

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FDA Restricts Use of Avandia

Pharmacy Focus

- Use of Avandia® and other products with rosiglitazone restricted …

- FDA pulls propoxyphene and products containing propoxyphene from market …

- Cedars-Sinai Pharmacy and Therapeutics Committee Approvals …

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Meetings and Events

Alumni Association Business Meeting and Dinner 
Dec. 8

Policy, Practice, Perspective: End of Life Care at CSMC
Dec. 15

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FDA Restricts Use of Avandia®

Pharmacy Focus

Avandia® safety information update

The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia® (rosiglitazone) as well as other products containing rosiglitazone, such as Avandamet® (rosiglitazone with metformin) and Avandaryl® (rosiglitazone with glimepiride), to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia®.

It will take several months for a restricted-access program to be put in place for rosiglitazone; however, once the REMS program is in place, current users of the drug will only be able to continue using the medication if they acknowledge and document that they understand the risks associated with the drug.

Currently, the FDA recommends that patients taking rosiglitazone, or products containing the drug, should continue taking the medication as prescribed and consult their healthcare professional.

FDA to withdraw propoxyphene due to risk of cardiac toxicity

The FDA has decided to withdraw propoxyphene and products containing propoxyphene from the U.S. market. This is in response to new data showing that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms.

The FDA is recommending that healthcare professionals stop prescribing and dispensing propoxyphene products to patients, contact patients currently taking the drug and ask them to discontinue its use, inform patients of the risks associated with propoxyphene, and discuss alternative strategies for pain management.

Propoxyphene was removed from the Cedars-Sinai formulary in May 2009.

Pharmacy and Therapeutics Committee Approvals

The committee announced the addition of Abilify® IM to formulary, automatic substitution of morphine to Dilaudid® during shortage periods, and removal of Tetracaine 2% solution, among other items.

Pharmacy and Therapeutics Committee Approvals, October 2010