FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised (10-15-2012)

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FDA Statement on Fungal Meningitis Outbreak

Archive of Updates on Fungal Meningitis Outbreak<SUP>1</SUP>
NECC press release and a complete list of the firm's compounded products<SUP>2</SUP>.

[10-15-2012] 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, on October 4, the FDA advised providers to not use any NECC products. On October 6, NECC announced a recall of all its products. A complete list of all products subject to this recall can be accessed here [HTML<SUP>3</SUP> | PDF<SUP>4</SUP>]. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use.

Also as a result of the ongoing investigation of NECC, 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 cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.

In addition, 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.

FDA continues to evaluate these reports, and when the agency obtains additional information, it will be promptly relayed to the public. FDA has not confirmed that these three infections were, in fact, caused by an NECC product

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, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported 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. 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 here<SUP>5</SUP>.

FDA Advice to Healthcare Practitioners

The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use. Based on the new information described above, out of an abundance of caution, FDA advises you to follow-up with patients for whom you 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. FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories.

You should inform patients who received the NECC products noted above of the symptoms of possible infection and instruct them to contact you or another healthcare provider immediately if they experience any of these symptoms.

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).

The 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 today's announcement. We ask you to use your clinical judgment in deciding which patients are at risk and contact those patients in whatever communications mode you prefer, whether it is email, phone or letter. Face-to-face communication with patients is not necessary.

Clinicians are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch<SUP>6</SUP>.

Health care professionals may dial FDA?s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.

http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm

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Re: FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised (10-15-2012)

FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised

[Posted 10/15/2012]

AUDIENCE: Pharmacists, Risk Managers, Pain Medicine

ISSUE: As a result of the ongoing investigation of New England Compounding Center (NECC), 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 cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.

In addition, 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.

BACKGROUND: On October 4, the FDA advised providers to not use any NECC products. On October 6, NECC announced a recall of all its products. See the complete list of all products subject to this recall.<SUP>1</SUP> The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use.

RECOMMENDATION: FDA advises healthcare professionals to follow-up with patients who were administered any injectable medication from or produced by NECC, including injectable ophthalmic drugs used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012. Healthcare professionals and medical care organizations should inform patients who received the NECC products noted above of the symptoms of possible infection and instruct patients to contact their healthcare provider immediately if they experience any of these symptoms.


FDA advises healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• <LI sizset="50" sizcache="1">Complete and submit the report Online: www.fda.gov/MedWatch/report.htm<SUP>2</SUP>
• Download form<SUP>3</SUP> or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Healthcare professionals may dial FDA?s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.

[10/15/2012 - FDA Statement on Fungal Meningitis Outbreak<SUP>4</SUP>]
[10/15/2012 - Multistate Fungal Meningitis Outbreak Investigation<SUP>5</SUP> - CDC]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm

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Re: FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised (10-15-2012)

Update to the FDA statement:

FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised

*UPDATE, 10-16-2012: On 10-15-12 the health care facility notified CDC that the initial report of two transplant patients has been revised to one patient who received cardioplegia solution from NECC. The 10-15-12 statement has been revised to reflect this information.