FDA provides NECC Customer List 10/22/12
FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised – Update
[Update 10/18/2012] CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC (Lot #08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections. Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.
CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.
There is now available a Patient Notification Letter on the FDA “Update on Fungal Meningitis” webpage under the “Related Information” section. This letter template is for healthcare professionals notifying patients administered a drug produced by the New England Compounding Center (NECC) that has been recalled.
FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised
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.
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. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use.
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: Complete and submit the report Online
More than 90 cases of a rare fungal meningitis across nine states have been linked to steroid injections for chronic pain. The U.S. Centers for Disease Control (CDC) in Atlanta reported that seven people have died.
According to the CDC, steroid products produced by the New England Compounding Center of Framingham, Mass., have been linked to all of the cases. The company is now closed and has issued a voluntary recall of all of its products. The products were used to treat back pain.
The states that have reported cases are: Tennessee, Florida, North Carolina, Indiana, Michigan, Virginia, Maryland, Minnesota and Ohio.
The company stated it had shipped 17,676 vials of the steroid methylprednisolone acetate to 76 facilities in 23 states from July through September.
Other states that the company sent the contaminated products to are California, Connecticut, Georgia, Idaho, Illinois, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, South Carolina, Texas and West Virginia.
Federal health inspectors began inspecting the NECC plant last Monday. Inspectors found foreign particles in unopened vials, and after testing one of the unopened vials, they determined the substance was a fungus.
Meningitis is an inflammation of the protective membranes covering the brain and spinal cord. It is usually caused by an infection, frequently with bacteria or a virus, but it can also be caused by less common pathogens like fungi, according to the CDC. Fungal meningitis is very rare and, unlike viral and bacterial meningitis, it is not contagious.
Symptoms of fungal meningitis are similar to symptoms from other forms of meningitis, but they often appear more gradually and can be very mild at first. Additional typical meningitis symptoms like headache, fever, nausea and stiffness of the neck. People with fungal meningitis may also experience confusion, dizziness and discomfort from bright lights. Patients might just have one or two of these symptoms.