Navigation Links
'Greenish-Black' Contaminant in Vials of Steroid Behind Meningitis Outbreak: FDA
Date:10/28/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

FRIDAY, Oct. 26 (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 Friday, the U.S. Centers for Disease Control and Prevention said that 25 people have now died and 338 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 338 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 Friday had the following state-by-state breakdown of cases: Florida: 19 cases, including 3 deaths; Georgia, 1 case; Idaho, 1 case; Illinois, 1 case; Indiana: 43 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: 11 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.

More information

The U.S. National Library of Medicine has more about injections for back pain.

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


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. UGA researchers develop rapid diagnostic test for pathogens, contaminants
2. Reused Vials, Unsafe Injections Threatening Patients: CDC
3. Gatekeeper of brain steroid signals boosts emotional resilience to stress
4. Inhaled Steroids Lead to Big Drop in Asthma Deaths at Texas Hospital: Study
5. Steroid Nasal Sprays Show Small Benefit for Sinusitis: Study
6. Identifying asthma patients who tolerate lower doses of steroids remains problematic
7. Trivedi Beef, LLC Announces Breakthrough Beef Industry Data without the use of Antibiotic Drugs, Hormones or Steroids
8. Low steroid levels linked to increased risk of cardiovascular disease
9. Vitamin D deficiency and poorer lung function in asthmatic children treated with steroids
10. The scientific side of steroid use and abuse
11. Steroids Wont Ease Most Sinusitis Attacks, Study Finds
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
'Greenish-Black' Contaminant in Vials of Steroid Behind Meningitis Outbreak: FDA
(Date:3/27/2017)... (PRWEB) , ... March 27, 2017 , ... The homeowner ... the number of homeowners utilizing DIY and unlicensed contractors for renovations is also on ... or replacement project in 2015, and of those, 42% failed to use a licensed ...
(Date:3/24/2017)... ... March 24, 2017 , ... Clean ... dredged material, and hazardous and non-hazardous materials announced today the acquisition of privately ... acquisition will add four additional processing facilities and a vast array of additional ...
(Date:3/24/2017)... ... , ... The Radiology Business Management Association (RBMA) has named the ... their 12th year, are among the most prestigious in radiology marketing because a panel ... retooled to recognize achievements in both large budget (over $5,000) and small budget (under ...
(Date:3/24/2017)... ... March 24, 2017 , ... Shamanic healer and teacher ... Healing and Spiritual Awakening, proudly presents her Sacred Peru retreat with world ... and spiritual journey during the Summer Solstice will also be her final international ...
(Date:3/24/2017)... ... 24, 2017 , ... The law firm of Enea, Scanlan & Sirignano, ... Westchester resident Lauren C. Enea has joined the firm as an associate attorney. Ms. ... practice in elder law, Medicaid planning and applications, and Wills, Trusts and Estates. ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... Research and Markets has announced the addition of the ... 2022" report to their offering. ... The global wound care market was worth $24,482.9 million in ... during 2016-2022 Among the various wound care products type, the ... market in 2015. Among the various applications, surgical wound segment held the ...
(Date:3/24/2017)... Mar. 24, 2017 Research and Markets has announced ... report to their offering. ... This report analyzes the worldwide markets for Dental Implants in US$ ... Canada , Japan , Europe ... and Rest of World. Annual estimates and forecasts are ...
(Date:3/24/2017)... 2017 ShangPharma, a leading life ... drug development and discovery services, technology, and ... announced today the intent for a strategic ... consolidating the Contract Research Organizations (CRO) and ... These entities include ChemPartner Shanghai, ChemPartner Fengxian, ...
Breaking Medicine Technology: