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FDA Warning for NECC Cardioplegic Solutions

No Longer Accepting Cases

October 17, 2012 — The New England Compounding Center (NECC) has recalled more than 1,000 medications for potential fungal contamination. Epidural steroid injections have been linked to a massive outbreak of fungal meningitis, which has sickened at least 247 people and killed 19.

The U.S. Food and Drug Administration (FDA) has reported that at least one person who was treated with another medication from NECC developed an infection with the same type of fungus linked to the meningitis outbreak. The man was treated with cardioplegic solution during open heart surgery, and the FDA is concerned that other people may have also been exposed to this infection risk.

The FDA first published a Safety Announcement on October 15 with the following warning about cardioplegic solutions from NECC:

“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.”

The next day, the FDA revised this after finding that only one of the patients was actually treated with a cardioplegic solution from NECC. Even so, the FDA warned that “cardioplegic solutions produced by NECC are of significant concern.”

The heart transplant patient was infected with Aspergillus fumigatus, a type of fungus that rarely causes infection. It is normally found in soil, leaves, or grass. It is not contagious, and outbreaks of disease caused by this organism are rare.

The FDA has also issued updated guidance for healthcare professionals. They recommend contacting any patients who were treated with recalled medications.

The FDA also listed the following symptoms of a fungal infection:

  • 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 mixture that is used to disrupt the normal electrical activity of the heart (essentially, inducing cardiac arrest) during open heart surgery. The product allows a surgeon to perform an operation on a quiet, relaxed, bloodless heart, which reduces the risk of injury to the patient during the operation. It is intended to be used only during cardiopulmonary bypass, when the patient’s circulatory system is isolated from the heart.

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