November 28, 2012 – This week, the Centers for Disease Control and Prevention (CDC) announced that the number of cases in the nationwide fungal meningitis 0outbreak has reached 510, including at least 36 people who died as a result of their illness. The vast majority of the cases involved meningitis, but there were also 14 patients who developed peripheral joint infections. This week’s update is the first the CDC has issued since November 19, when the center reported 490 cases of fungal meningitis, 12 joint infections, and 34 deaths.
Compounding Pharmacy Recall Update 8/12/13: Texas-based compounding pharmacy Specialty Compounding, LLC, has issued a nationwide recall for all lots of medications it has processed since May 9. To date, at least 15 people have been diagnosed with a rare bacterial infection after being administered injections of calcium gluconate at a pair of Texas hospitals. In response to this and a number of other recent compounding pharmacy recalls, the FDA is asking Congress for increased oversight and authority over these operations.
Fungal Meningitis Update 1/30/13: This week, a federal judge ruled that assets of the company at the center of last year’s unprecedented fungal meningitis outbreak will be frozen indefinitely. An emergency injunction was placed on the New England Compounding Center (NECC) after the owners were accused of funneling more than $21 million out of the company’s assets before filing for bankruptcy in December.
What’s the problem?
The outbreak was first identified in September, when a Tennessee man was diagnosed with a rare form of meningitis whose source could not be traced. Eventually, the man’s doctors found evidence of fungal infection with a mold known as Aspergillus Fumigatus. A subsequent investigation linked the illness and several others that had been reported in the meantime to methylprednisolone acetate, a widely-prescribed injectable steroid painkiller used to treat chronic back and joint pain.
The drug, which was processed and prepared by the New England Compounding Center (NECC) in Framingham, Mass., was later found to be contaminated by a fungus, although not with Aspergillus. Instead, focus shifted to a black mold known as Exserohilum rostratum, an organism that has rarely been known to cause disease in humans. The fungus was found in a number of vials of methylprednisolone acetate that were processed by NECC, as well as in several of the infected patients.
Once the source of the outbreak was identified, NECC first issued a recall for methylprednisolone acetate, and then later for all drugs processed by the company this year. NECC’s sister company, Ameridose of Westborough, Mass., also issued an emergency recall for all of its drugs. These events have sparked intense debate over the regulation of so-called ‘compounding pharmacies,’ and led to questions of what safeguards should be put in place to avoid future catastrophes.
NECC had shipped three lots of approximately 17,000 vials of tainted methylprednisolone acetate to 23 states by the time the source of the outbreak was identified. According to the CDC, about 14,000 patients were administered injections of the drug, and illnesses have been reported in 19 of the 23 states. Hardest hit has been Michigan, where there have been 178 cases, including 10 joint infections and 10 deaths. Tennessee, the state where the outbreak was first identified, has reported 84 cases of fungal meningitis and 13 deaths.