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There has been an outbreak of the deadly fungal meningitis disease in the US, affecting thousands of people with 16 people already dead. According to the website of the Center for Disease Control and Prevention (CDC), authorities are gravely concerned with the sudden outbreak linked to pharmacy-distributed steroids.
The outbreak of fungal meningitis has been directly linked to steroids supplied by Massachusetts-based New England Compounding Center (NECC); the company has announced that it is proceeding with an “abundance of caution” because of the risk of contamination, although there is no evidence so far that any of its other products have been contaminated.
Meningitis is a rare disorder that evolves as a consequence of spreading fungus through the blood to the spinal cord. It is generally caused by the inflammation of protective membranes covering the brain and spinal cord called meninges. In other words it is swelling of edges or lining around spinal cord and brain.
Speculation tells us that injections distributed by NECC, called methylprednisolone acetate, used widely to nurse back pain, may have been cause of this clinical mayhem. Close to 13,000 people may have received the drug as part of their treatment. So far cases of meningitis have surfaced in Tennessee, Michigan, Pennsylvania, New Hampshire, Illinois, Indiana, Minnesota, New Jersey, Texas, Idaho, Maryland, North Carolina, Virginia, Ohio and Florida.
According to the CDC, more than 20 states have received the implicated drugs, and it has launched a multistate investigation to figure out the underlying cause of meningitis outbreak.
The CDC issued a cautionary call for patients who feel ill. They advise that anyone who is concerned about whether they received medication from the NECC should contact their physician. The CDC also issued clinician guidelines stating that physicians should contact patients who have been exposed. The CDC also warned that people with weaker immune systems, like those suffering from AIDS, are at greater risk of getting infected with fungal meningitis.
Dr Michael Carome, from a Washington based public advocacy group Public Citizen, said “Congress exempted drugs compounded by pharmacists from the usual safety and efficacy requirement.”
If speculation turns out to be true, and the cause of the outbreak is pharmacy miscalculation, then from broader perspective it is a regulatory loophole rather than clinical blunder.
David Miller, Chief Executive Officer at IACP, brought severity to the situation when he said that “this is not traditional compounding we’re talking about, it is multi-state selling and large-scale manufacturing.”