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

Mark Your Calendar


Surgery Grand Rounds

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Grand Rounds

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Educational Schedule

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

Educational Schedule - March 2014 (PDF)


Surgery Scheduling

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

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FDA Warns About Doribax; Victrelis Label Changed

Pharmacy Focus

The U.S. Food and Drug Administration has concluded that Doribax® (doripenem), an antibacterial drug used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (the combination is marketed in the U.S. under the name Primaxin®). Also, changes have been made to the label of Victrelis®.

Based on an FDA analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, the agency approved changes to the Doribax drug label that describe these risks. The revised label includes a new warning about this unapproved use. Doribax is not approved to treat any type of pneumonia.

According to the FDA, healthcare professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators. Doribax is still considered safe and effective for its FDA-approved indications — treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections (pyelonephritis).

Click here to learn more.

Changes Made to Victrelis Label

The FDA said the label of the hepatitis C drug Victrelis has been updated to include information about serious cases of pancytopenia that have been reported in patients receiving Victrelis in combination with peginterferon alfa and ribavirin. Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment and at treatment weeks two, four, eight and 12, the FDA said. Blood counts should be monitored closely at other times, as clinically appropriate.

The label also was updated to include the risk of agranulocytosis, thrombocytopenia, pneumonia and sepsis.

Separately, the FDA approved an update to the Victrelis label to include a new virologic futility rule: If a patient has HCV-RNA results greater than or equal to 1,000 IU/mL at treatment week eight, then discontinue the three-medicine regimen.

Discontinuation of therapy is recommended in all patients with any of the following:

  • HCV-RNA levels of at least 1,000 IU per mL at treatment week eight
  • HCV-RNA levels of at least 100 IU per mL at treatment week 12
  • Confirmed detectable HCV-RNA levels at treatment week 24

The complete revised label can be viewed here.