October 27, 2012
Fungal Meningitis Cases Climb, Plus FDA Investigation Uncovers Mold In Vials
Lawrence LeBlond for redOrbit.com - Your Universe Online
The US death toll from a fungal meningitis outbreak tied to contaminated steroid injections has climbed to 25. Total cases have also climbed to 331, with an additional seven cases of joint infections, according to data from the US Centers for Disease Control and Prevention (CDC).
South Carolina became the latest state to have an affected case, the 18th of 23 states that had received the steroid injections from the New England Compounding Center in Framingham, Massachusetts. Michigan has the highest case count, with 89 reported cases; Tennessee follows with 74 cases; Indiana and Virginia both share 43 cases.
The latest death was reported in Tennessee, the state where the problem was first discovered, bringing the total number of deaths in the state to 10, according to the CDC´s daily update. Michigan has five reported deaths, Florida and Indiana each have three, Virginia has two, and one death has been reported in Maryland and North Carolina.
Additionally, 8 cases were reported on Friday in the states of Maryland, Michigan, Minnesota, New Hampshire and Tennessee.
The NECC is now facing multiple investigations and a swarm of lawsuits. The company shipped out some 17,000 contaminated steroid injections beginning last May, of which at least 14,000 were administered to patients in 76 facilities in 23 states. Health authorities are blaming the contamination on failure of the Framingham-based pharmaceutical to ensure medications were produced in sterile conditions.
An investigation by the US Food and Drug Administration (FDA) has found visible mold inside NECC´s facility, including 83 vials from one lot of the tainted steroid that contained “greenish black foreign matter.” An additional 17 vials in that bin of 321 vials of methylprednisolone acetate also had white fibers floating in them during the inspection.
FDA investigators visited the NECC several days between October 1 and October 26. The FDA confirmed that other vials from this same lot had already been shipped out to clinics around the country between August 17 and September 25.
In a released report, the FDA said NECC did not do proper sterility testing on the steroid, sending out only one vial from the entire lot for testing, which passed the test. But after testing 50 more vials in the same lot, the FDA found contamination in all of them. National guidelines states that a minimum of 20 vials per batch should be tested.
The FDA in its report, also said it found greenish yellow or other discoloration inside autoclaves, which are used to sterilize vials, stoppers, and compounded drugs. The company itself conducted its own testing and showed signs of bacteria and mold in numerous spots in two “clean rooms”--where sterile drugs are prepared--between January and September, but there is no evidence the company investigated further or took corrective measures, said the report.
Furthermore, the company did not assess whether products made in the “clean rooms” on the days samples were taken could have become contaminated, the report noted.
The company´s own formula for making methylprednisolone acetate called for the use of sterile ingredients. However, according to the FDA report, NECC actually made the product from non-sterile bulk powder, and the company did not have documentation showing that the steam autoclave cycle it was using was effective at sterilizing these types of raw materials.
Strangely enough, the compounding center is adjacent to a recycling facility, also owned by the same family, that handles materials and plastics. Excavators and freight trucks on the site spewed dust into the air, and rooftop heating and air conditioning units on New England Compounding were only 100 feet from the recycling operations, according to the report.
Investigations of the heating and air-conditioning unit inside the compounding facility revealed a dark and white substance. The ventilation from that system blew directly behind the autoclave used to sterilize methylprednisolone acetate.
NECC released a statement on Friday, saying: “We will review this report and will continue our cooperation with the FDA. We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report.”
Conditions observed by the FDA were similar to those found by state investigators last Tuesday.
Massachusetts Governor Deval Patrick said the state would immediately begin annual, unannounced inspections of the roughly 25 other compounding facilities in the state that prepare sterile injectable medications such as those linked to the outbreak.
A list of the clinics that had received recalled lots of the injectable, can be found here.