Questions and Answers on Fungal Meningitis Outbreak

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Q1. What is FDA’s role in the investigation?

A1. FDA was been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of Registration in Pharmacy, have been conducting an inspection of the New England Compounding Center. FDA has confirmed the presence of a fungal contaminant in multiple sealed vials of methylprednisolone acetate collected from NECC, and is in the process of conducting additional testing to confirm the species of the fungus.

Q2. Is New England Compounding Center still producing sterile injectable products?

A2. No. The firm voluntarily ceased all operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012. NECC has also announced a voluntary recall of all of their products.

Q3. What should health care providers do to protect their patients from the threat of potential contamination?

A3. Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, we are advising you not to use it at this time. Please see the CDC website² for additional information. See Q9 regarding advice to health care providers related to the additional injectable products, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.

Q4. Are there other FDA approved epidural steroid injections that can be used?

A4. There are FDA approved versions of methylprednisolone acetate injection on the market, available with or without preservatives. The FDA-approved products are not approved for epidural administration.

Q5. Does FDA anticipate a shortage of epidural steroid injection drug supply?

A5. No. FDA’s drug shortage office has confirmed that NECC’s voluntary shutdown will not affect the nationwide supply of methylprednisolone acetate.

Additional Patient Notification Advisory

Q6. What led FDA to take this action?

A6: As a result of FDA, CDC, and state health departments’ ongoing investigation of contamination at the New England Compounding Center’s (NECC) Framingham, Massachusetts facility, we have learned that two patients may have infections associated with other possibly contaminated NECC products. While the investigation of these patients is ongoing, and there may be other explanations for their infections, out of an abundance of caution, we are issuing new guidance for providers to contact their patients for whom they administered an injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012.

With regard to the two patients who are being evaluated, we can provide the following information. One patient, identified through active surveillance, is under investigation for possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide. Triamcinolone acetonide is a type of steroid injectable product made by NECC. FDA-approved triamcinolone acetonide is approved for intra-articular (within a joint) or soft tissue injection. The cases of meningitis identified to date have all been associated with methylprednisolone acetate, another similar steroid injectable product.

In addition, one heart transplant patient with Aspergillus fumigatus infection who was administered NECC cardioplegic solution during surgery hase 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.

At this time, no patients are under investigation in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection because of concerns about sterility.

Q7: Does FDA believe these products are contaminated with the same fungus as the methylprednisolone acetate?

A7: At this point in the investigation, FDA analysis of triamcinolone acetonide collected from the health care facility that reported the new meningitis case is being cultured, and we will release results when available.

Q8: Does FDA believe all products compounded by NECC are at risk?

8A: The investigation is ongoing. On October 4, we urged providers not to use any products made at NECC. At this point in FDA’s investigation, 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.

Q9: What should HCPs and patients do who were given these products?

A9: The FDA has previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use. NECC has voluntarily recalled all products that it has distributed. Based on new information, FDA advises that if, after May 21, 2012, a health care professional administered to a patient an injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC, the healthcare professional should follow up with those patients and make sure the patients are aware of the signs and symptoms of infection and instruct them to contact their health care provider immediately if they have any of these symptoms. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that can be accessed here³.

At this time, FDA is not advising health care professionals to contact patients who have been administered lower risk NECC products such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories.

Patients who believe they received an injection or other product compounded by NECC after May 21, 2012 should remain vigilant for the signs and symptoms of infection, including meningitis. The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest). Patients should contact their healthcare provider if they have any of these signs or symptoms.

Q10: FDA is advising doctors to contact any of the patients to whom they have administered an NECC injectable drug, including ophthalmic products or cardioplegic solutions, after May 21, 2012. How many products does that encompass?

A10: NECC has provided a list of products that they have produced and distributed, which can be found and accessed here [HTML⁴ | PDF⁵]. There are about 1200 products on that list. A large percentage of these products are injectables, including ophthalmic products that are injectable or used in conjunction with eye surgery and cardioplegic solutions. FDA is working with NECC to produce a specific list of injectables, including ophthalmic products and cardioplegic solutions, and will post that as soon as possible.

Q11: What steps should health care professionals take to communicate with patients?

A11: FDA recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of FDA’s recommendation. FDA defers to the clinical judgment of healthcare professionals to decide the appropriate communications mode, whether it is email, phone (including voicemails), letter, or otherwise. Face-to-face communication with patients is not necessary to notify patients.

Q12: Are the FDA-approved versions of triamcinolone acetonide contraindicated for epidural administration?

A12: FDA-approved triamcinolone acetonide is approved for intra-articular (within a joint) or soft tissue injection. The FDA-approved triamcinolone acetonide is not approved for spinal injections.

Q13: What should patients do if they are diagnosed with meningitis or joint infections associated with the use of contaminated NECC products?

A13: Patients who have been diagnosed with meningitis or joint infections should consult with their healthcare providers about the appropriate treatment regimen, including the risks and benefits of all treatment options. CDC has published interim treatment guidance for adult patients diagnosed with central nervous system and/or parameningeal infections as well as septic arthritis associated with injection of potentially contaminated steroid products from NECC. These recommendations include treatment with an antifungal drug called voriconazole. CDC also advises providers to consider giving another antifungal drug, liposomal amphotericin B, in addition to voriconazole, to treat patients with severe disease and patients who do not respond to voriconazole alone. Providers can refer to CDC’s website at http://www.cdc.gov/hai/outbreaks/clinicians/index.html⁶ for the most up-to-date CDC treatment recommendations.

Q14: In your MedWatch message, FDA advised healthcare professionals to follow-up with patients who have been administered an injectable product shipped by NECC on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution. Are there other clinical settings where FDA suggests healthcare professionals follow-up with patients?

A14: In addition to injectable NECC products, ophthalmic drugs used in conjunction with eye surgery, and cardioplegic solution shipped on or after May 21, 2012, there are other potential uses of NECC products where FDA advises healthcare professionals to use their clinical judgment in deciding when to follow-up with patients. Other clinical conditions that warrant follow-up with patients who received NECC products on or after May 21, 2012, include but are not limited to:

• Infusion into a sterile body site
• Irrigation of a sterile body site (e.g., bladder, skin laceration, intra-operative)
• Inhalation
• Application to an eye with a corneal abrasion
• Transplant of an organ (e.g., organ transplant)

Q15: What advice is available for patients who may have NECC products in their implantable pump?

A15. FDA is aware of the possibility that products made and distributed by the New England Compounding Pharmacy (NECC) may have been intended for use in implantable pumps for a variety of patient populations. These products were recalled by NECC earlier this month. In some cases, the nature of the implant may make compliance with the recall notice impractical or unsafe. FDA continues to evaluate information as it becomes available, but at this time does not have sufficient data to determine the degree of risk or concern associated with any continued exposure to these products. FDA urges health care providers and clinics that purchased NECC products for use in implantable pumps to maintain a heightened vigilance for signs of infections in those patients or their pumps, and to reach out to those patients to discuss medical options available to them as appropriate.

Source: http://www.fda.gov/Drugs/DrugSafety/ucm322735.htm