FDA now scrutinizing other NECC products for contamination

Robin Wulffson MD's picture
fungal meningitis, contamination, deaths, strokes, NECC, sterile products
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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.

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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.

Representative John D. Dingell (D-Mich), has written the F.D.A. asking for an estimate of how many people are at risk of infection or meningitis from products made by the company. He is calling for a Congressional investigation of the outbreak. On October 17, the representative said that he was particularly concerned about reports of at least four previous complaints to the Massachusetts Board of Registration in Pharmacy regarding the sterility of the company’s products. He noted, “Does Food and Drug talk to the Massachusetts regulatory agency and vice versa? There’s evidence that they don’t.” He added that he was particularly interested in learning whether the contamination could be traced to unhygienic practices at the company or to the products it used to make the drugs. He said, “Was it a matter of slovenly manufacturing practices inside this particular compounder, or were they buying unsafe components that they were putting into this?”

Reference:
FDA
CDC

See also:
Federal criminal investigators raid tainted steroid maker NECC
FDA warns of risk from other tainted drugs produced by NECCCompany responsible for fungal meningitis cases skirted state and federal laws
Fungal meningitis stats continue to worsen
Fungal meningitis outbreak raises safety issues regarding compounding pharmacies
CDC reports that thousands received tainted epidural injections

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