Cedars-Sinai Medical Center

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A BI-WEEKLY PUBLICATION FROM THE CEDARS-SINAI CHIEF OF STAFF Nov. 22, 2013 | Archived Issues

Formulary Expanded; FDA Warns About Immune Globulins, Spinal Catheters, Cardiac Drugs

Pharmacy Focus

The Pharmacy and Therapeutics Committee added ticagrelor (Brilinta®) to the formulary and took other actions Oct. 1. Also, the U.S. Food and Drug Administration has cautioned about human immune globulin products, the use of spinal catheters in patients taking anticoagulants and two cardiac stress test agents.

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Formulary Expanded; FDA Warns About Immune Globulins, Spinal Catheters, Cardiac Drugs

Pharmacy Focus

The Pharmacy and Therapeutics Committee added ticagrelor (Brilinta®) to the formulary, along with other actions at its Oct. 1 meeting. The committee's actions are summarized in the PDF link below.

Also, the U.S. Food and Drug Administration has added a warning to human immune globulin products, has made recommendations regarding the use of spinal catheters in patients taking anticoagulant drugs and has issued warnings about two cardiac stress test agents.

P and T Committee Actions - Oct. 1, 2013 (PDF)

FDA Revises Warning for Immune Globulin Products

The U.S. Food and Drug Administration has approved changes to the prescribing information for human immune globulin products to add a new boxed warning about the risk of thrombosis. The revised labels also include underlying risk factors for thrombosis, and recommendations for monitoring and managing patients on these products to mitigate the risk of thrombosis.

The FDA has analyzed recent data that has strengthened the association between the use of intravenous, subcutaneous and intramuscular human immune globulin products and the risk of thrombosis. Additional caution regarding the use of these products is warranted.

Human immune globulin products are used in a variety of conditions, both on- and off-label, by healthcare professionals who may not be aware of the thrombosis risk and measures that could be taken to mitigate this risk.

The information on thrombosis in the final approved boxed warning states:

  • Thrombosis may occur with immune globulin products.
  • Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors.
  • Thrombosis may occur in the absence of known risk factors.
  • For patients at risk of thrombosis, administer immune globulin products at the minimum dose and infusion rate practicable.
  • Ensure adequate hydration in patients before administration.
  • Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

For more information, click here.

Use Extra Care With Spinal Catheters in Patients on Anticoagulants, FDA Says

The U.S. Food and Drug Administration is recommending that healthcare professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures.

These new timing recommendations, which can decrease the risk of epidural or spinal hematoma, will be added to the labels of anticoagulant drugs known as low molecular weight heparins, including Lovenox, generic enoxaparin products and similar products.

Epidural or spinal hematomas are a known risk of enoxaparin in the setting of spinal procedures and are already described in the boxed warning and in the warnings and precautions sections of the labels for Lovenox and generic enoxaparin products. However, these serious adverse events continue to occur, so the FDA updated the warnings.

For more information, click here.

FDA Warns of Risks With Lexiscan, Adenoscan

Due to recent reports of serious adverse events, the U.S. Food and Drug Administration has approved changes to the drug labels for the cardiac stress test agents regadenoson (Lexiscan®) and adenosine (Adenoscan®), including a warning regarding the rare but serious risk of heart attack and death, as well as recommendations for use:

  • Screen all nuclear stress test candidates for suitability to receive Lexiscan or Adenoscan
  • Avoid use in patients with signs or symptoms of unstable angina or cardiovascular instability
  • Cardiac resuscitation equipment and trained staff should be available prior to administration

For more information, click here.