Information about Additional Medical Products (non-MPA) from New England Compounding Center

FDA Updates

Information on this site is focused on products other than the three lots of preservative-free methylprednisolone acetate (MPA) associated with the multi-state outbreak of fungal meningitis and other infections. For laboratory results on preservative-free MPA implicated in the outbreak, see CDC’s outbreak website.

Summary

On September 26, 2012, NECC voluntarily recalled three lots of preservative-free MPA associated with the multistate outbreak of fungal meningitis and other infections.
On October 6, NECC expanded its recall to include all products in circulationthat were distributed from its facility in Framingham, Massachusetts.
FDA released a MedWatch Safety Alert on October 15 stating that the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegia solutions produced by NECC is of significant concern.
As part of the ongoing investigation, FDA and CDC have been testing various NECC products for evidence of contamination. The FDA and CDC laboratories have identified bacteria and/or fungi present in NECC-supplied preservative-free injectable betamethasone, preservative-free triamcinolone, and cardioplegia solution (specific lots listed below).
To date, although CDC has received reports of illness in patients who have received the medications listed in the table below, including some patients who had evidence of meningeal inflammation, CDC and public health officials have no reports of laboratory-confirmed bacterial or fungal meningitis, spinal, or paraspinal infections caused by these products.
The available epidemiological and laboratory data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products.
If you have taken or used any medication from NECC and feel sick, you should seek medical attention. Any infections potentially related to NECC products should be reported to FDA’s MedWatch and to your state health department.

Top of Page

Laboratory Testing and Results

Vials and test tubes on top of a periodic table.

CDC and FDA have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis, Aspergillus fumigatus, Cladosporium species, and Penicillium species. Although rare, some of the identified Bacillus species can cause disease in humans. Some of the fungal organisms identified, particularly Aspergillus fumigatus, are also known to cause disease in humans. It is not known how product contamination with these organisms could affect patients clinically. See CDC's Advice for Clinicians below.

CDC and FDA Laboratory-Confirmed Organisms from Product Samples
Laboratory-Confirmed Organisms from Product Samples Associated with NECC Recalled Lots of Betamethasone, Cardioplegia, and Triamcinolone Solutions
Medication	Lot Number	Microbial Contamination
Betamethasone 6 mg/mL injectable – 5 mL per vial	08202012@141	Paenibacillus pabuli/amolyticus; Bacillus idriensis; Bacillus flexus; Bacillus simplex; Lysinibacillus sp., Bacillus niacini, Kocuria rosea, Bacillus lentus
Betamethasone 6 mg/mL injectable – 5 mL per vial	07032012@22	Bacillus niabensis; Bacillus circulans
Betamethasone 12 mg/mL injectable – 5 mL per vial	07302012@52	Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis
Betamethasone 6mg/mL injectable – 5 mL per vial	08202012@44	Bacillus lentus, Bacillus firmus, Bacillus pumilus
Betamethasone 6 mg/mL injectable – 5 mL per vial	08152012@84	Penicillium sp., Cladosporium sp.
Triamcinolone 40mg/mL injectable – 1 mL per vial	06062012@6	Bacillus lentus, Bacillus circulans, Bacillus niabensis, Bacillus nealsonii, Bacillus subtilis group, Bacillus firmus
Triamcinolone 40 mg/mL injectable – 2 mL per vial	08172012@60	Aspergillus tubingensis, Penicillium sp.
Triamcinolone 40mg/mL injectable – 10 mL per vial	08242012@2	Aspergillus fumigatus
Cardioplegia solution 265.5 mL per bag	09242012@55	Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

Advice to Clinicians

FDA released a MedWatch Safety Alert on October 15 stating that the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegia solutions produced by NECC is of significant concern. FDA advised healthcare providers to follow-up with patients who were administered any of these products purchased from or distributed by NECC on or after May 21, 2012. A sample notification letter [PDF - 1 page] to assist with this process is available.

CDC's recommendations to healthcare providers for diagnosing and treating symptomatic patients who have received NECC products have not changed as a result of these findings. CDC continues to recommend that clinicians remain vigilant for the possibility that infections may have resulted from injection of NECC products, and that routine laboratory and microbiologic tests, including bacterial and fungal cultures, should be obtained as necessary by treating clinicians.

There has been no prior regular surveillance for adverse events following epidural steroid injections; however, infection is a known, although likely rare, risk that has been documented in the medical literature. To date, although CDC has received reports of illness in patients who have received the medications listed in the table above, including some patients who had evidence of meningeal inflammation, CDC and public health officials have no reports of laboratory-confirmed bacterial or fungal meningitis, spinal, or paraspinal infections caused by these products. The available epidemiological and laboratory data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products.

However, because it is possible that some of the organisms listed in the table above can cause human disease, clinicians should continue to include bacterial and/or fungal infection in the differential diagnosis when evaluating symptomatic patients who were exposed to these medications, including consideration of empiric anti-bacterial and/or antifungal therapy.

Consultation with an infectious disease specialist is strongly encouraged to help make diagnosis and treatment decisions in these cases. If the evaluation of these patients is suggestive of fungal infection, please consult existing CDC treatment guidance associated with this outbreak.

Physicians should continue to report infections potentially related to NECC products to FDA's MedWatch and to state health departments.

Top of Page

Advice to Patients

If you have taken or used any medication from NECC and feel sick, you should seek medical attention. Any infections potentially related to NECC products should be reported to FDA’s MedWatch and to your state health department.