"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.