National attention has been focused on rare, potentially deadly fungal meningitis and drug safety after health officials discovered a link between growing reports of the illness and a steroid made at a Massachusetts company.
Patients at a local pain clinic may have received doses of the suspect steroid, but so far there have been no confirmed cases of fungal meningitis in South Carolina.
But in 13 other states, new fungal meningitis cases and deaths have been reported daily. In response, state and federal officials have been scrambling to assess the situation and reassure the public.
The disease and investigation are complex, but there is basic information about the situation that addresses health concerns as experts work to contain the outbreak and prevent more fatalities.
Q. What is fungal meningitis?
A. It is a rare infection that is usually the result of the spread of a fungus through the blood to the spinal cord. Although anyone can get fungal meningitis, people with weak immune systems are at higher risk.
Q. Who is at risk?
A. The disease is not contagious. Those who may be at risk received one or more spinal injections of a possibly-tainted steroid. Currently, 257 patients who received spinal injections of methylprednisolone acetate at Intervene MD of Mount Pleasant and North Charleston are being monitored. None have been diagnosed with fungal meningitis, but 12 were referred for further evaluation. No other South Carolina clinics are currently involved in the situation.
Q. How big is the problem?
A. Officials estimate that up to 13,000 people may be affected nationwide.
Q. Why is methylprednisolone acetate suspected?
A. Investigators found a fungus in multiple vials of methylprednisolone acetate made at New England Compounding Co. They are in the process of determining whether the species of fungus found in the vials is the same as two fungal organisms found in patients.
Q. How many cases have been reported?
A. As of Sunday, the Centers for Disease Control and Prevention reported 205 confirmed cases of fungal meningitis in 14 states. There have been 15 deaths. Officials said 76 medical facilities in 27 states received the possibly contaminated steroid from NECC.
Q. What is being done to contain the outbreak?
A. NECC has shut down and about 5,000 suspected vials of contaminated methylprednisolone acetate have been recalled.
Q. What are the symptoms of fungal meningitis?
A. They include fever, headache, stiff neck, nausea and vomiting, sensitivity to light and altered mental status.
Q. What is the drug compounding process NECC used to manufacture the suspect steroids?
A. Traditionally, compounding has been a way to prepare medications that are not available commercially, such as a drug for a patient who is allergic to an ingredient in a mass-produced product, or diluted dosages for children.
Q. Who regulated NECC?
A. The FDA and the Commonwealth of Massachusetts. The advocacy group Public Citizen charges that the situation at NECC highlights a failure of the FDA's regulatory oversight of drugs prepared and sold by compound pharmacies. Public Citizen said NECC appears to have crossed the line from the traditionally narrow role filled by local compounding pharmacies into one that involves drug manufacturing and release of products into interstate commerce.
Q. Are there other, safe versions of methylprednisolone acetate available?
A. Yes, and the FDA anticipates no shortage of the steroid for pain management as a result of the shutdown of NECC.