June 30

In this Issue:


Drug Safety Warnings for:


Varenicline (Chantix) Cardiovascular Safety

Simvastatin – Safety of 80 mg Dose


Please note, the links below will take you to the UNC Health Care Intranet.

Epoetin/Darbepotein – Safety in Patients with Chronic Kidney Disease

The FDA has issued new dosing recommendations for patients with chronic kidney disease receiving either epoetin or darbepoetin.



Varenicline (Chantix) Cardiovascular Safety

The FDA has issued a warning regarding the cardiovascular safety of varenicline, a drug that is used to aid in smoking cessation.



Simvastatin – Safety of 80 mg Dose

The FDA is no longer recommending that simvastatin be used at a dose of 80 mg/day. Please refer to the message from June 17 regarding this change (full text below).


June 17, 2011

FDA Recommendations regarding patients taking simvastatin

Last week, the FDA released a statement that provides the following recommendations for clinicians regarding patients taking simvastatin at the 80 mg dose.


FDA recommends that healthcare professionals should:

•           Maintain patients on simvastatin 80 mg only if they have been taking this dose for 12 or more months without evidence of muscle toxicity.

•           Not start new patients on simvastatin 80 mg.

•           Place patients who do not meet their LDL cholesterol (LDL-C) goal on simvastatin 40 mg on alternative LDL-C lowering treatment(s) that provides greater LDL-C lowering (see Relative LDL-lowering Efficacy of Statin and Statin-based Therapies below).

•           Follow the recommendations in the simvastatin-containing medicines labels regarding drugs that may increase the risk for muscle injury when used with simvastatin (see Simvastatin Dose Limitations below).

•           Switch patients who need to be initiated on a drug that interacts with simvastatin to an alternative statin with less potential for the drug-drug interaction.

•           Report adverse events involving simvastatin-containing medicines to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.


The full FDA statement is available at:  http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm


Next week, UNC Health Care will use the data warehouse to identify patients within WebcCIS who have simvastatin at the 80 mg dose as an active med on their med list. Every primary care and cardiology provider with patients identified through WebCIS will receive a list from ISD through their medical director. Please review this list and consider the FDA's recommendations for your patients.


In addition to sending the list of identified patients, UNC Health Care will draft a letter that can be used to notify identified patients of the change in the FDA recommendation regarding simvastatin. A copy of this draft letter will be sent all PCPs and cardiologists through their medical directors. Clinics and providers will be responsible for communicating this information to their patients, either through distribution of the letter or by phone calls from the clinic.


If you have any questions about the FDA recommendation, please call e-mail Dr. Donald Spencer, Vice President and Medical Director of Ambulatory Care at dspencer@unch.unc.edu.