More than 300 people who received a tainted steroid sold by NECC that was used to treat back pain have been infected with fungal meningitis and 25 have died.
The US Food and Drug Administration found visible mold inside the Framingham pharmacy at the center of the national fungal meningitis outbreak, including 83 vials from one lot of the tainted steroid used to treat back pain that contained ?greenish black foreign matter.
FDA investigators visited New England Compounding Center over seven days between Oct. 1 and Oct. 26, which was after the steroid was recalled by the company.
Red flags ignored for years at firm in meningitis crisis
The Massachusetts specialty pharmacy linked to the deadly fungal meningitis outbreak knew it had extensive contamination by mold and bacteria throughout its operations for making sterile drugs but failed to take corrective actions.
In March, regulators responded to a complaint from the prestigious Massachusetts Eye and Ear Infirmary about a potency concern involving one of the eye medications it purchased from NECC. The investigation is ongoing.
Over the summer, physicians at Ruby Memorial Hospital in West Virginia returned a bag of cardioplegia solution used in heart surgery after a patient did not respond as expected.
As far back as 1999, barely a year after NECC was formed, the Massachusetts Board of Registration in Pharmacy responded to a complaint from a pharmacist alleging that Barry J. Cadden, chief pharmacist and co-owner of NECC, had improperly provided a healthcare provider with prescription blanks. The Board voted to issue an informal, non-disciplinary reprimand.
Complaints about irregularities in NECC’s prescription ordering process have emerged periodically for more than a decade.
FDA and CDC
The investigators also observed problems with NECC?s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination. Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.
The FDA continues to work closely with the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC?s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid.
Fungal Meningitis Lawyers Alert Patients to Reports of Drug Safety Lapses at Compounding Pharmacy
Morgan and Morgan is alerting patients to reports that an inspection of the New England Compounding Center found a number of serious health and safety deficiencies. The firm continues to investigate potential lawsuits on behalf of patients who contracted meningitis in connection with this recent outbreak.
The attorneys at Morgan and Morgan are currently offering a free fungal meningitis lawsuit evaluation to patients who were diagnosed with meningitis during this recent outbreak. More than 300 people have been diagnosed with fungal meningitis in connection with the suspect steroids, which may have been administered in as many as 14,000 patients, according to the U.S. Centers for Disease Control.
Source: U.S. Food and Drug Administration, USA