Twenty-five people are dead; 331 are suffering from fungal meningitis; an additional 7 people havedeveloped fungal infections in other joints (knees, elbows, etc). All courtesy of a pharmaceutical compounding facility that is filthier than many dog kennels!
FDA released its Preliminary Inspection Report (Form 483) today, and the observations are nauseating. A small sampling of the specifics include:
1. On 10/02/2012, we observed approximately eighty-three (83) vials out of a bin containing 321 vials of methylprednisolone acetate (preservative free) 80mg/mL from Lot #08102012@51 (shipped to customers between 8/17/12 – 9/25/12 …), a sterile injectable drug, to contain what appeared to be greenish black foreign matter. Seventeen (17) vials from the same bin… were observed to contain … white filamentous material.
The sterility sample taken by the firm … from lot 08102012@51 resulted in a sterile result… However, the FDA analysis of … Lot #08102102@51 collected from the firm, confirmed the presence of viable microbial growth in 50/50 vials tested. One vial examined microscopically showed fungal morphological features.
2. Although the formula worksheets state the raw materials are sterile, the Pharmacy Director stated that the firm uses non sterile active pharmaceutical ingredients (APIs) and raw materials, with the exception of sterile water for injection…The firm provided no documentation or evidence to support that the steam autoclave cycle used to sterilize suspensions formulated using non-sterile API and raw materials is effective.
3. The firm’s environmental monitoring program yielded … (bacteria and mold) within Clean Room 1 and Clean Room 2, used for the production of sterile drug products, between January 2012 and September 2012.
There was no investigation conducted by the firm when levels exceeded their actions limits and there was no identification of the isolates. No documented corrective actions were taken to remove the microbial contamination … from the facility.
And there’s much, much more.
The bottom line is that New England Compounding Center (NECC) used non-sterile materials to manufacture a sterile injectable drug It did so under “Clean Room” conditions that would put a student undergraduate microbiology lab to shame. AND the company neglected to act on lab results that clearly demonstrated that the environment was badly contaminated with bacteria and mold.
Exserohilum rostratum (courtesy of CDC)
As a result of the company’s cavalier attitude, innocent patients in eighteen states have suffered fungal meningitis – in some cases, resulting in stroke – or septic arthritis after receiving injections from one of three lots of methylprednisolone acetate produced by NECC. Although one of the patients was infected with Aspergillus fumigatus and one with Cladosporium, most of the infections were due to a fungus called Exserohilum rostratum – the same mold found by FDA in unopened vials of the “sterile” medication.
NECC “voluntarily” recalled 40 mg/ml and 80 mg/ml strengths of Methylprednisolone Acetate on October 3rd, and extended the recall to all lots of its remaining products the following day. Please consult the Commonwealth of Massachusetts notice for a detailed list of recalled products.
As of October 26th, illnesses have been reported from the following states:
Florida: 19 cases (3 deaths)
Georgia: 1 case
Idaho: 1 case
Illinois: 1 case
Indiana: 43 cases (3 deaths)
Maryland: 19 cases (1 death)
Michigan: 82 cases (5 deaths)
Minnesota: 9 cases
New Hampshire: 11 cases
New Jersey: 18 cases
New York: 1 case
North Carolina: 2 cases (1 death)
Ohio: 11 cases
Pennsylvania: 1 case
South Carolina: 1 case
Tennessee: 74 cases (10 deaths)
Texas: 1 case
Virginia: 43 cases (2 deaths)
Heathcare facilities in 23 states were supplied with the contaminated medication.
California
CYPRESS SURGERY CENTER. 559-740-4094; Visalia, CA
ENCINO OUTPATIENT SURGICENTER. 818-986-1037; Encino, CA
UKIAH VALLEY MEDICAL CENTER. 707-463-7345; Ukiah, CA
UNIVERSAL PAIN MANAGEMENT. 661-267-6876 x166; Palmdale, CA
Connecticut
INTERVENTIONAL SPINE AND SPORTS MED. 203-598-7246; Middlebury, CT
INSIGHT IMAGING-ROANOKE. 540-581-0882; Roanoke, VA
NEW RIVER VALLEY SURGERY CENTER. 540-639-5888; Christiansburg, VA
West Virginia
PARS INTERVENTIONAL PAIN. 304-865-7277; Parkersburg, WV
CDC has posted the following advice for patients of these facilities:
Find out if you received a potentially contaminated medication.
If you are concerned about which product was used in your procedure, you should first contact the physician who performed your procedure.
Recalled lots of injectable methylprednisolone acetate received by 23 states
The facilities that received one of the three lots of methylprednisolone acetate (a steroid product) recalled by New England Compounding Center (NECC) on September 26, 2012, are actively contacting patients to find out if they are feeling well. This is the medication that has been associated with fungal infections in patients.
As of October 20, 97 percent of patients who received medication from one of the three lots have been contacted.
Other NECC products under investigation
Out of an abundance of caution, the FDA is advising doctors, to follow-up with patients who received an NECC injectable product shipped after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, and a cardioplegic solution. CDC does not have firm evidence that fungal infections have been caused by exposure to other NECC products.
If patients have taken or used medications from NECC, and they are worried that they are sick because of use of one of these products, they should seek medical attention.
If you have received a potentially contaminated medication, seek medical attention if you have symptoms.
You may have very mild symptoms that are only slightly worse than usual. For example, many infected patients who received epidural or paraspinal injections have had slight weakness, slightly worsened back pain, or even a mild headache.
Patients who received injections into a joint have experienced increasing pain and swelling of the joint. Patients with infections have typically developed symptoms within 1-4 weeks after their injection. However, shorter and longer timeframes between injection and onset of symptoms have been reported. Therefore, patients need to closely watch for these symptoms for at least several months following the injection. If you do develop these symptoms, you should see a doctor.
Novartis announced today that it has relaunched three of the over-the-counter medications that disappeared from circulation when the company was forced to suspend operations at its Lincoln, Nebraska manufacturing facility.
Excedrin Migraine, Triaminic and Lamisil were relaunched in mid-October, according to the company’s quarterly report presentation. Excedrin Extra Strength is expected to follow in January. Due to continued delays in bringing the Lincoln facility fully on-line, the manufacture of these products has been contracted out to a third party.
The Lincoln plant was idled last January after FDA observed numerous violations – many of them repeat violations – during a reinspection of the manufacturing facility. The company has been working with FDA to correct the violations and, gradually, resume full production. But progress, according to company management, has been slower than expected.
Pet owners will be disappointed to learn that Interceptor – a popular heartworm prophylactic for dogs and cats that also was manufactured in Lincoln – did not even rate a mention during the company’s quarterly conference call with investors and analysts. There is no indication of when, or whether, this product will return to the market.
eFoodAlert 