U.S. health officials reported an additional 27 cases of fungal meningitis outbreak linked to a steroid injection that has killed 8 people, and infected 105 in nine states. The amount of victims affected by this contamination has doubled over the weekend.
As we reported earlier last week, there has been an outbreak of tainted steroid injections, used mostly for the treatment of back pain, which was manufactured at the New England Compounding Company (NECC) in Framingham, Massachusetts. The widening outbreak has concerned U.S. health officials and focused attention on regulations of pharmaceutical compounding companies like the one that produced the drugs.
A compounding pharmacy takes medications from pharmaceutical manufacturers and makes them into specific dosages and strengths for use by doctors.
Compounding pharmacies do not need Food and Drug Administration’s approval before they are sold and the agency has no jurisdiction over how products are manufactured or labeled for use.
The FDA has tried to exert greater authority over compounding drug products under a section of the Food and Drug Cosmetic Act that covers new drugs. Those efforts led to federal court challenges that resulted in two separate and conflicting rulings at the appellate level.
The company shipped 17,676 vials of the steroid methylprednisone acetate to 76 facilities in 23 states from July – September, the Massachusetts Health Department said.
The steroid is used as a painkiller, usually for the back, and could have been injected into thousands of patients, authorities said.
Meningitis is an inflammation of the membranes covering the brain and spinal cord and affected patients started showing a variety of symptoms from 1-4 weeks after their injection.
U.S. Center for Disease Control and Prevention (CDC) reported a new total of 91 cases in an update on its website, up from 64 on Saturday. Most of the new cases were reported in Michigan, where the total increased to 18 from 11.
The 9 states where fungal meningitis cases have been reported are Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia.
Tennessee, where the outbreak is detected, accounted for most of the cases, with 32, including 3 deaths. Many patients there remain hospitalized, some in critical condition.
Michigan had 20 cases and 2 deaths. One person died in Maryland and another in Virginia, the CDC said. The age range is 38-89 years old.
After inspectors found at least one (sealed) vial to be contaminated by the leaf fungus, the CDC stated that the outbreak was possibly the result of the steroid, which was manufactured by the NECC. It is unclear how the fungus got into the steroid. To be safe, health officials have warned all health care professionals not to use any products manufactured by the NECC.
Reuters had reported 65 cases on Sunday, including one additional case after the CDC published its total.
It could be weeks before any of the patients, several of whom have had strokes related to the meningitis, are in the clear.
On Sunday, the New York Times that the Cochrane Collaboration, an internal group of medical experts who reviewed the data on the benefits of steroid injections last year, found “no strong evidence for or against” the injections, suggesting the possibility that so many patients have potentially risked their health and their lives for little or no gain.
The disease is diagnosed with a lumbar puncture, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.
Fungal meningitis is not contagious, the CDC said. Symptoms include fever, headache, nausea and neurological problems that would be consistent with deep brain stroke.
The steroid was sent to 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, Texas, Virginia and West Virginia, the CDC said.
Many more cases will be reported, as symptoms do not present sometimes until a month following injection.
A list of facilities that received vials from the infected lots can be found via the website cdc.gov.
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