Note: This story originally ran Oct. 16 and was updated Oct. 17.
In connection with the outbreak of fungal meningitis related to a tainted steroid, the Food and Drug Administration has announced that at least one case of meningitis may be related to an epidural injection of a different product from the same company.
As a result of the ongoing investigation of the New England Compounding Center’s Framingham, Mass., facility, a patient with possible meningitis potentially associated with an injection of triamcinolone acetnoide has been identified. The cases of meningitis identified to date — the total reported number was 245, plus two cases of joint infection, with 19 deaths, as of Oct. 17 — have been associated with methylprednisolone acetate, another similar steroid injectable product.
In addition, the FDA has received a report of a transplant patient with Aspergillus fumigatus infection who was administered NECC cardioplegic solution during surgery. Investigation of this patient is ongoing. The FDA stressed that it has not confirmed that these two infections in fact were caused by an NECC product.
NECC announced a recall of all its products on Oct. 6. The FDA had issued guidance for medical professionals that all products distributed by NECC should be retained, secured and withheld from use.
Based on the new information, out of an abundance of caution, the FDA advises following up with patients who received 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.
The FDA does not urge patient follow-up at this time for NECC products of lower risk, such as topicals and suppositories.
Recognizing that some healthcare professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of the latest announcement, the FDA stated: "We ask you to use your clinical judgment in deciding which patients are at risk and contact those patients in whatever communications mode your prefer, whether it is email, phone or letter. Face-to-face communication with patients is not necessary."
Healthcare professionals may dial the 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.
For the latest clinical updates on the meningitis outbreak from the Centers for Disease Control and Prevention, visit www.cdc.gov/hai/outbreaks/clinicians/index.html.
In connection with the outbreak of fungal meningitis related to a tainted steroid, the Food and Drug Administration has announced that at least one case of meningitis may be related to an epidural injection of a different product from the same company.
As a result of the ongoing investigation of the New England Compounding Center’s Framingham, Mass., facility, a patient with possible meningitis potentially associated with an injection of triamcinolone acetnoide has been identified. The cases of meningitis identified to date — the total reported number was 245, plus two cases of joint infection, with 19 deaths, as of Oct. 17 — have been associated with methylprednisolone acetate, another similar steroid injectable product.
In addition, the FDA has received a report of a transplant patient with Aspergillus fumigatus infection who was administered NECC cardioplegic solution during surgery. Investigation of this patient is ongoing. The FDA stressed that it has not confirmed that these two infections in fact were caused by an NECC product.
NECC announced a recall of all its products on Oct. 6. The FDA had issued guidance for medical professionals that all products distributed by NECC should be retained, secured and withheld from use.
Based on the new information, out of an abundance of caution, the FDA advises following up with patients who received 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.
The FDA does not urge patient follow-up at this time for NECC products of lower risk, such as topicals and suppositories.
Recognizing that some healthcare professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of the latest announcement, the FDA stated: "We ask you to use your clinical judgment in deciding which patients are at risk and contact those patients in whatever communications mode your prefer, whether it is email, phone or letter. Face-to-face communication with patients is not necessary."
Healthcare professionals may dial the 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.
For the latest clinical updates on the meningitis outbreak from the Centers for Disease Control and Prevention, visit www.cdc.gov/hai/outbreaks/clinicians/index.html.
Send comments to editor@nurse.com or post comments below.
