Federal agencies raided the New England Compounding Center located in Framingham, Massachusetts just after the U.S. Center for Disease Control announced that that the number of the meningitis outbreak 2012 cases reported in the U.S. doubled over the last week.
“I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center. I think that it is entirely premature to suggest what the results of the investigation will be,” said U.S. Attorney for Massachusetts Carmen M. Ortiz in a statement.
As of October 15, 2012, a total of 231 cases in 15 states and 15 deaths have been identified with a clinical picture consistent with fungal infection: Florida (12 cases, including 2 deaths), Idaho (1 case), Illinois (1 case) Indiana (30 cases, including 2 deaths), Maryland (16 cases, including 1 death), Michigan (47 cases, including 3 deaths), Minnesota (5 cases), New Hampshire (6 cases), New Jersey (10 cases), North Carolina (2 cases), Ohio (7 cases), Tennessee (59 cases, including 6 deaths), Texas (1 case) and Virginia (35 cases, including 1 death). Fungus has been identified in specimens obtained from patients, including Aspergillus and Exserohilum.
The CDC says that while investigation into the exact source of these infections is ongoing, all infected patients received preservative-free methylprednisolone acetate from among the three lots voluntarily recalled by the New England Compounding Center in Framingham, Massachusetts, on September 25, 2012.
Infected patients have presented approximately one-to-four weeks following their injection with a variety of symptoms including fever, new or worsening headache, nausea and our new symptoms consistent with a stroke. Some of these patients symptoms were very mild in nature.
All patients who may have received these medications need to be tracked down immediately. Patients can find the names of the clinics that used these medications on the CDC website,” said Benjamin Park, M.D., medical officer, Mycotic Diseases Branch, CDC. “It is possible that if patients with infection are identified soon and put on appropriate antifungal therapy, lives may be saved.”
Infected patients have developed a variety of symptoms approximately 1 to 4 weeks following their injection, including fever, new or worsening headache, nausea, and new neurological deficit (consistent with deep brain stroke). Some of these patients’ symptoms were very mild in nature. Cerebrospinal fluid obtained from these patients has shown findings consistent with meningitis.
On September 26, 2012, the New England Compounding Center voluntarily recalled the following lots of methylprednisolone acetate (PF) 80mg/ml:
- Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
- Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
- Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013
Physicians should immediately contact patients who have had an injection (e.g., spinal, joint) using any of the three lots of methylprednisolone acetate listed above to determine if they are having any symptoms. Although all cases detected to date occurred after injections with products from these three lots, out of an abundance of caution, CDC and the Food and Drug Administration (FDA) recommend that healthcare professionals cease use of any product produced by the New England Compounding Center until further information is available.
The CDC says that cerebrospinal fluid obtained from these patients has shown findings consistent with meningitis. It is important to note that this type of meningitis is not transmissible from person-to-person.
Patients may be experiencing mild symptoms, not typical of meningitis. Such as new or worsening headache without fever or neck stiffness. The CDC warns that if patients are having new or worsening symptoms, even mild symptoms, they should be evaluated immediately.
While the CDC is only aware of infections occurring in patients who have received epidural steroid injections, the CDC advises that patients who received other type of injections of methylprednisolone acetate from those three lots should be tested from signs of infection such as swelling, increasing pain, redness and warmth at the injection site and should be encouraged to seek evaluation if such symptoms exist
There are the 23 States that received preservative-free methylprednisolone acetate among the three recalled lots: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Iowa, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia.
Is the source of the outbreak known?
CDC is investigating medications and products that are associated with this outbreak of meningitis. At this point, there is not enough evidence to determine the original source of the outbreak, however there is a link to an injectable steroid medication. The lots of medication that were given to patients have been recalled by the manufacturer.
What are the states that received the implicated product?
California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia
What is meningitis?
Meningitis refers to inflammation of the protective membranes covering the brain and spinal cord known as the meninges. The inflammation is usually caused by an infection frequently with a bacteria or virus, but meningitis can also be caused by less common pathogens such as fungi.
The severity of illness and the treatment for meningitis differ depending on the cause. Thus, it is important to know the specific cause of meningitis.
What is fungal meningitis?
Fungal meningitis occurs when the protective membranes that cover the brain and spinal cord are infected with a fungus. Fungal meningitis can develop after a fungus spreads through the bloodstream from somewhere else in the body, as a result of the fungus being introduced directly into the central nervous system, or by direct extension from an infected body site next to the central nervous system.
Is fungal meningitis common after epidural injections?
Epidural injections are generally very safe procedures, and complications are rare. Fungal meningitis is an extremely rare cause of meningitis overall, including after epidural injections. The type of epidural medication given to patients affected by this outbreak is not the same type of medication as that given to women during childbirth.
What are the symptoms of fungal meningitis?
Symptoms of fungal meningitis are similar to symptoms of other forms of meningitis, however they often appear more gradually and can be very mild at first. In addition to 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.