FDA Warning for NECC Cardioplegic Solutions

October 17, 2012 — The U.S. Food and Drug Administration (FDA) is reporting that one heart transplant patient who was treated with cardioplegic solution from New England Compounding Center (NECC) has tested positive for Aspergillus fungal contamination. NECC previously recalled more than one thousand medications for potential fungal contamination.

New England Compounding Center’s epidural steroid shots have been implicated in an outbreak of fungal meningitis, which has caused at least 247 illnesses and 19 deaths. The FDA is concerned that other medications, including cardioplegic solution, may also be contaminated and could potentially cause fungal infections.

On October 15, the FDA published a Safety Alert with the following warning:

“Two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have been reported. Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.”

On October 16, the FDA revised this to say that only one heart transplant patient was treated with a cardioplegic solution from NECC. The patient tested positive for the Aspergillus fumigatus fungus, which is normally found in soil or decaying plant material.

The FDA recommends against using any medication from NECC, warning that “cardioplegic solutions produced by NECC are of significant concern.”

The FDA has also issued new guidance for healthcare professionals and health organizations. They are advised to contact any patients who may have been exposed to cardioplegic solutions from NECC during open heart surgery.

Symptoms of a fungal infection include:

• Fever
• Swelling
• Increasing pain, redness, or warmth at injection site
• Visual changes
• Pain, redness, or discharge
• Chest pain
• Drainage from the surgical site (could indicate chest infection)

Cardioplegic solution is a chemical solution used to induce cardiac arrest (which stops heart electrical activity and heartbeat) during open heart surgery. It prevents injury to the heart muscle during surgery, allowing a surgeon to operate on a quiet, relaxed, and bloodless heart. It is only supposed to be used during cardiopulmonary bypass, when a patient’s heart is isolated from their circulation system.