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THE US Food and Drug Administration (FDA) says that two more drugs made by New England Compounding Center (NECC) have been linked to a fatal outbreak of fungal meningitis in the US.

According to the US Centers for Disease Control and Prevention, 15 people have now died from the disease, caused by Exserohilum sp. and Aspergillus fumigatus, while 214 people are infected across 15 states. As well as meningitis, the fungi can infect joints. The outbreak was initially linked to an epidural steroid injection, methylprednisolone acetate. Now the FDA reports that three patients infected with the same fungus have been found who have never received this drug. One was injected with a similar epidural steroid made by NECC, triamcinolone acetonide. The other two patients received an NECC cardioplegic solution, used to stop the heart during open-heart surgery.

The FDA cautions that there may yet be other explanations for the infections, and that investigations are ongoing. However, it has issued new guidelines for medical practitioners. It says that no NECC products manufactured after 21 May 2012 should be used, and any patients who have already received injectable NECC treatments should be monitored carefully for signs of infection.

“The sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection,” says the FDA, adding that while ophthalmic drugs have yet to be linked to fungal infections, the risk is similar to that of the steroid.

Compounding pharmacies like NECC make up specialised doses of existing medicines for individual patients – for example at a certain strength or without certain allergens, or turning tablets into medicines for children. The outbreak of fungal infections linked to NECC products has raised concerns about the safety and scrutiny of compounding.

FDA investigations have found fungi present in unopened NECC steroid vials, while equipment (such as trays) has tested negative. Madeleine Biondolillo of the Massachusetts Department of Public Health confirms that NECC is being investigated for potentially breaking state regulations regarding compounding, which states that doses must be prepared for individual patients.