October 15, 2012 — The U.S. Food and Drug Administration (FDA) has published a Safety Alert after identifying several patients who suffered fungal infections after being treated with other medicines from New England Compounding Center (NECC). The FDA has identified three possible infections from triamcinolone acetonide (a type of epidural steroid shot) and cardioplegic solution (used to paralyze the heart muscle during open heart surgery).
The New England Compounding Center initially recalled three lots of an epidural steroid shot (methylprednisolone acetate) after the products were linked to an outbreak of fungal meningitis. On October 5, the NECC voluntarily recalled all lots of all other medicines due to potential fungal contamination. It was seen as a precautionary measure at the time, because no illnesses had been linked to other medicines.
Now it appears that several people may have been sickened by other medicines produced by New England Compounding Center. According to the FDA:
“A patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC.”
The FDA has also identified two other patients who were treated with cardioplegic solution:
“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 FDA is recommending that physicians who have treated patients with a product from New England Compounding Center should contact the patients for a follow-up.
Patients who may have been exposed to contaminated medications should contact the physician who performed the procedure to find out if they were treated with a medicine from NECC. Because fungal meningitis has an incubation period of several weeks or months, patients who have been exposed should watch for symptoms of the disease. The FDA warns that symptoms of fungal meningitis are often mild, and they may include headache, fever, stiff neck, nausea and vomiting, sensitivity to light, confusion, or altered mental status.
Other infections may have the following symptoms: Fever, swelling, increasing pain, redness, warmth at the injection site, visual changes, redness or discharge from the eye, chest pain, drainage from surgical site.