'Greenish-Black' Contaminant in Vials of Steroid Behind Meningitis Outbreak: FDA
Posted Oct 27 2012 1:00pm
Officials say 25 are now dead, 338 sickened from tainted injections.
By Steven Reinberg and Margaret Steele HealthDay Reporters
SATURDAY, Oct. 27 (HealthDay News) -- Federal investigators who toured the plant at the center of the ongoing meningitis outbreak found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses, U.S. health officials said Friday.
The contaminated product was one of a host of potential violations discovered during a recent inspection of the New England Compounding Center's plant in Framingham, Mass., officials said.
"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the U.S. Food and Drug Administration's Office of Manufacturing and Product Quality, said during a news conference Friday afternoon.
As of Saturday, the U.S. Centers for Disease Control and Prevention said that 25 people have now died and 344 people in 18 states have been sickened in the nationwide fungal meningitis outbreak.
Vials from the lot Lynn described were shipped by the company to customers this year, he said. The FDA tested 50 of these vials and all were contaminated with fungus, he added.
In addition, the company couldn't demonstrate that the equipment used to sterilize these products was actually able to sterilize them, Lynn said.
The FDA also found the company was not able to keep its "clean room" clean, Lynn said. "A clean room is a space designed to maintain a controlled environment with low levels of airborne particles and surface contamination," he explained.
According to the report, the company failed to keep the air conditioner in the clean room running at night, which is standard practice to maintain the room's humidity and temperature control. In the past, the company itself had found mold and bacteria in the clean room, Lynn said.
"In addition, the investigators observed a dark, hair-like discoloration in a transition room that connects directly to a room used to formulate and fill the injectable products," Lynn said. They also found leaking pipes and standing water at the entrance to the room where the equipment used in the clean room is prepared. This can allow microbes to enter the clean room, he added.
FDA officials noted that the report does not have legal force, and is not the final word on whether the company violated the law.
However, Massachusetts officials said Tuesday that they had begun a criminal investigation into New England Compounding Center. They added that the company functioned as a drug manufacturer, producing drugs for broad use, rather than filling individual prescriptions for individual doctors, in violation of its state license, CBS News reported.
According to published reports, state records show that the New England Compounding Center was plagued by problems as far back as 2006. Those records, obtained by the Associated Press under a public documents request, showed there was evidence of inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the facility.
New England Compounding Center is what's known as a compounding pharmacy. These pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients, according to the FDA. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.
Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers are, but some members of Congress now say the meningitis outbreak highlights the need for more regulatory control.
Meningitis is a potentially fatal inflammation of the lining surrounding the brain and spinal cord.
Federal health officials said last week that fungus found in steroid injections produced by the company matched the fungus linked to the meningitis outbreak. The officials said they'd confirmed the presence of the fungus, Exserohilum rostratum, in unopened vials of a steroid produced by the New England Compounding Center.
The steroid, methylprednisolone acetate, is injected into patients for back and joint pain. The company has since shut down operations and stopped distributing its products, health officials said.
The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the three lots, and nearly 97 percent of them have been contacted for medical follow-up.
All of the fungal meningitis patients identified so far were thought to be injected with methylprednisolone acetate from the Massachusetts pharmacy, according to the CDC.
Seven of the 344 cases involve what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip, shoulder or elbow. These joint infections aren't considered as dangerous as injections near the spine for back pain that have been linked to the potentially fatal meningitis infections.
The FDA said it was advising all health care professionals to follow up with any patients who were given any injectable drug from or produced by the New England Compounding Center. These drugs include medications used in eye surgery, and a heart solution purchased from or produced by the company after May 21.
The CDC on Saturday had the following state-by-state breakdown of cases: Florida: 22 cases, including 3 deaths; Georgia, 1 case; Idaho, 1 case; Illinois, 1 case; Indiana: 44 cases, including 3 deaths; Maryland: 19 cases, including 1 death; Michigan: 82 cases, including 5 deaths; Minnesota: 9 cases; New Hampshire: 11 cases; New Jersey: 18 cases; New York: 1 case; North Carolina: 2 cases, including 1 death; Ohio: 13 cases; Pennsylvania: 1 case; South Carolina: 1 case; Tennessee: 74 cases, including 10 deaths; Texas: 1 case; Virginia: 43 cases, including 2 deaths.
Health officials said they expect to see more cases of the rare type of meningitis, which is not contagious, because symptoms can take a month or more to appear.
Infected patients have developed a range of symptoms approximately one to four weeks following their injection. People who have had a steroid injection since July, and have any of the following symptoms, should talk to their doctor as soon as possible: worsening headache, fever, sensitivity to light, stiff neck, new weakness or numbness in any part of your body or slurred speech, the CDC said.
Infected patients must be treated with intravenous drugs in a hospital.
(SOURCES: Oct. 26, 2012, news briefing with: Steven Lynn, director, Office of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Oct. 26, 2012, updated statistics, U.S. Centers for Disease Control and Prevention; Oct. 18, 2012, news release, U.S. Centers for Disease Control and Prevention, and U.S. Food and Drug Administration; CBS News; Associated Press)