An outbreak of fungal meningitis has infected 91 people in the US and killed nine. The US Centers for Disease Control and Prevention said this week that 13,000 people could be at risk.
The outbreak has been linked to contamination of a steroid drug sold across 23 states.
The New England Compounding Center (NECC) in Framingham, Massachusetts, which produces the steroid, has recalled 17,676 vials and is working with the US Food and Drug Administration (FDA) to identify the source of contamination.
Meningitis is a potentially fatal inflammation of the brain or spinal cord, most often caused by bacteria or viruses. In the current outbreak, however, it appears two fungal species are to blame.
Compounding pharmacies normally combine drugs prepared elsewhere to create bespoke versions for individual patients. But some, like the NECC, have moved on to produce drugs on a larger scale. They are exempt from standard FDA regulations.
The FDA has sought to restrict such pharmacies from advertising their products but the Supreme Court overturned this in 2002.
"Clearly, there are disturbing questions as to whether, how and why this business was engaged in the wholesale manufacture and sale of a prescription drug product, rather than the filling and dispensing of prescription medicines to patients, without regulatory intervention," says David Miller, CEO of the International Academy of Compounding Pharmacists.
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