Pharmaceutical

CDC, FDA lab tests on contaminated steroid shots strengthen link to fungal meningitis outbreak

syringe CDC, FDA lab tests on contaminated steroid shots strengthen link to fungal meningitis outbreakLaboratory tests results on unopened vials of steroid shots made by a Massachusetts compounding pharmacy strengthen the link between the steroid injections and the deadly multistate fungal meningitis outbreak, the Centers for Disease Control and Prevention (CDC) announced late Wednesday.

Scientists with the CDC and the Food and Drug Administration (FDA) tested unopened vials of the three recalled lots preservative-free methylprednisolone acetate (MPA). Two batches of the steroid tested positive for the black mold Exserohilum rostratum. This fungus is the same genus and species as the one found in laboratory-confirmed cases of human infection.

Scientists also identified in the vials non-human pathogens Rhodotorula larynges and Rhizopus stolonifer. These non-human pathogens are not known to cause disease in humans as they cannot grow at human body temperatures. Tests on the third lot are ongoing.

To date, 368 people have developed fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection after receiving steroid shots from the affected lots in the spine for back pain. Twenty-eight of them have died. Nine others have developed infections in joins such as the knee, shoulder, hip or elbow, after receiving injections in those joints for pain.

Nearly 18,000 of the contaminated vials were distributed to health care facilities in 23 states. An estimated 14,000 people received the tainted shots. New England Compounding Center, the specialty pharmacy that made the shots, has recalled all its products and was ordered to close all operations as federal health officials conduct their investigation.

Source: CDC