FDA now scrutinizing other NECC products for contamination


Oct 18 2012 - 1:00pm
fungal meningitis, contamination, deaths, strokes, NECC, sterile products

The New England Compounding Center (NECC), which produced the steroid injections contaminated with fungal meningitis, is now under scrutiny for other products that might be contaminated. The FDA is now dealing with the possibility that some of the more than100,000 shipments of other drugs from NECC may have caused other types of infections. It appears that the infections are due to improper sterilization practices at NECC.

The New England Compounding Center (NECC), which produced the steroid injections contaminated with fungal meningitis, is now under scrutiny for other products that might be contaminated. As new meningitis cases continue to surface, the Food and Drug Administration (FDA) is now dealing with the possibility that some of the more than100,000 shipments of other drugs from NECC may have caused other types of infections. They are also continuing an intense effort to warn physicians and patients. It appears that the infections are due to improper sterilization practices at NECC.

The Centers for Disease Control and Prevention (CDC) announced that four more deaths have been confirmed in the last 24 hours, bringing the total to 19. Two of those deaths occurred in Tennessee, the state hardest hit with eight deaths since the infections were discovered in late September. The CDC also noted that the number of new fungal meningitis cases linked to NECC steroid injections rose by 14 to 245. Two additional infections have not been confirmed as meningitis. Tennessee also has the highest number of cases in the US: 61 cases. Behind Tennessee is Michigan, with 48 cases, including three deaths.

The infections are due to vials of the steroid methylprednisolone acetate, which were contaminated with a fungus. The drug was injected into the spine and joints for pain relief. More than 17,000 vials were shipped to 23 states. The latest statistics serve as a reminder that one of the worst US health scares in recent years has not been contained; this has occurred despite emergency steps to recall the medications and stop the use of NECC products.

The FDA has extended its focus to other drugs made by NECC. The agency has provided state health departments with a list of more than 131,000 shipping invoices for NECC products that were sent all over the United States. The products of most concern are drugs used during open-heart surgery and eye operations, as well as another steroid, triamcinolone, which is also used in spinal injections. Beyond those products of most concern, other products are also suspect; the list of drugs made by the company runs to 71 pages.

According to a statement on the Tennessee Health Department Web site, the agency reviewed an invoice list and determined that 74 healthcare facilities in the state had received suspect products. On October 17, Tennessee health officials began contacting the clinics, which in turn are advised to warn their patients. The officials express significant concern regarding the possible contamination of all NECC products that were supposed to have been sterile. The products include all injectable medicines and other products used during surgery. In addition, some health departments are launching an investigation to determine whether certain types of fungal infections in the past year were connected to NECC products from the company. The investigation includes review of death records.

Pages