ASPERGILLUS MENINGITIS - USA (03): CONTAMINATED DRUG
****************************************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[1]
Date: Fri 5 Oct 2012
Source: NBC News, Associated Press (AP) report [edited]
<http://vitals.nbcnews.com/_news/2012/10/05/14241074-hundreds-may-be-at-risk-in-meningitis-outbreak?lite>
The potential scope of the meningitis outbreak that has killed at
least 5 people widened dramatically Thu 4 Oct 2012, as health
officials warned that hundreds, perhaps thousands, of patients who got
steroid back injections in 23 states could be at risk. Clinics and
medical centers rushed to contact patients who may have received the
apparently fungus-contaminated shots and the FDA urged doctors not to
use any products at all from the Massachusetts pharmacy that supplied
the suspect steroid solution. It is not clear how many patients
received tainted injections, or even whether everyone who got one will
get sick.
So far, 35 people in 6 states -- Tennessee (25), Virginia (4),
Maryland (2), Florida (2), North Carolina (1) and Indiana (1) -- have
contracted fungal meningitis, and 5 of them have died, according to
the CDC. All had received steroid shots for back pain, a highly common
treatment.
In an alarming indication the outbreak could get a lot bigger,
Massachusetts health officials said the pharmacy involved, the New
England Compounding Center [NECC] of Framingham, MA, has recalled 3
lots consisting of a total of 17 676 single-dose vials of the steroid,
preservative-free methylprednisolone acetate. An unknown number of
those vials reached 75 clinics and other facilities in 23 states
between July 2012 and September 2012, federal health officials said.
Several hundred of the vials, maybe more, have been returned unused, a
Massachusetts official said.
But many other vials were used. At a clinic in Evansville, Indiana,
more than 500 patients got injections from the suspect lots, officials
said. At 2 clinics in Tennessee, more than 900 patients, perhaps many
more, did.
The investigation began about 2 weeks ago after a case was diagnosed
in Tennessee. The time from infection to onset of symptoms is anywhere
from a few days to a month, so the number of people stricken could
rise.
Investigators this week found contamination in a sealed vial of the
steroid at the New England company, according to FDA officials. Tests
are under way to determine if it is the same fungus blamed in the
outbreak. The company has shut down operations and said it is working
with regulators to identify the source of the infection.
"Out of an abundance of caution, we advise all health care
practitioners not to use any product" from the company, said Ilisa
Bernstein, director of compliance for the FDA's Center for Drug
Evaluation and Research.
The type of fungal meningitis involved is not contagious like the more
common forms. It is caused by a fungus often found in leaf mold and is
treated with high-dose antifungal medications, usually given
intravenously in a hospital. The common mold _Aspergillus_ was
cultured from 5 patients, the CDC said Thursday [4 Oct 2012].
The New England company is what is known as a compounding pharmacy.
These pharmacies custom-mix solutions, creams, and other medications
in doses or in forms that generally aren't commercially available.
Other compounding pharmacies have been blamed in recent years for
serious and sometimes deadly outbreaks caused by contaminated
medicines. Compounding pharmacies are not regulated as closely as drug
manufacturers, and their products are not subject to FDA approval.
A national shortage of many drugs has forced doctors to seek
custom-made alternatives from compounding pharmacies. The New England
company at the center of the outbreak makes dozens of other medical
products, state officials said. But neither the company nor health
officials would identify them.
The company said in a statement Thursday [4 Oct 2012] that despite the
FDA warning, "there is no indication of any potential issues with
other products." It called the deaths and illnesses tragic and added:
"The thoughts and prayers of everyone employed by NECC are with those
who have been affected."
A 2011 state inspection of the Framingham facility gave the business a
clean bill of health.
[Byline: Mike Stobbe]
- --
Communicated by:
ProMED-mail
<promed@promedmail.org>
類固醇止痛劑污染 美5死，至少35人感染真菌性腦膜炎
〔編譯俞智敏／綜合五日外電報導〕美國衛生官員警告說，由麻州「新英格蘭藥品調劑中心」（ＮＥＣＣ）所供應的一種治療背痛用的類固醇遭真菌污染，注射這種藥物的患者至少有三十五人感染真菌性腦膜炎，已有五人死亡。
據聯邦衛生官員表示，今年七月至九月間有數目不詳的類固醇藥瓶被送到二十三州的七十五間診所和醫療機構，印地安那州艾文斯維市的一間診所就有逾五百人恐已注射了這批問題藥物，田納西州的兩間診所更有逾九百人接受注射。目前田納西州感染病例達二十五人最多，並包括三名死亡病例，維吉尼亞和馬里蘭州也有患者不治。
衛生當局警告說，全美二十三州恐有數百、甚至數千人有遭到感染的風險。但目前並不清楚曾注射問題藥物的患者人數，也無法確知這些患者是否都會受感染。
據美國疾病管制與預防中心（ＣＤＣ）指出，已知包括田納西、維吉尼亞、馬里蘭、佛羅里達、北卡羅萊納及印地安那等六州共三十五人感染了真菌性腦膜炎，並有五人死亡，這些患者都曾因背痛接受類固醇藥劑注射這種常見的療法。不過這種真菌性腦膜炎並不會傳染，而且可透過靜脈注射高劑量的抗黴菌藥物治療。ＣＤＣ指出，從感染到症狀出現的時間可能從數天到一個月，因此受感染的人數恐繼續上升。涉案藥局也已暫停所有作業。
美處方調劑藥物 不像藥廠受到嚴格規範
藥品調劑中心負責依醫師處方來調劑特製藥物，並不像藥廠受到嚴格規範，所調製的藥品也不需經美國食品藥物管理局（ＦＤＡ）同意即可上市。過去數年來也曾有類似案件，但由於美國許多藥品短缺，迫使醫師不得不使用由這些藥局特別調製的藥品。
****************************************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[1]
Date: Fri 5 Oct 2012
Source: NBC News, Associated Press (AP) report [edited]
<http://vitals.nbcnews.com/_news/2012/10/05/14241074-hundreds-may-be-at-risk-in-meningitis-outbreak?lite>
The potential scope of the meningitis outbreak that has killed at
least 5 people widened dramatically Thu 4 Oct 2012, as health
officials warned that hundreds, perhaps thousands, of patients who got
steroid back injections in 23 states could be at risk. Clinics and
medical centers rushed to contact patients who may have received the
apparently fungus-contaminated shots and the FDA urged doctors not to
use any products at all from the Massachusetts pharmacy that supplied
the suspect steroid solution. It is not clear how many patients
received tainted injections, or even whether everyone who got one will
get sick.
So far, 35 people in 6 states -- Tennessee (25), Virginia (4),
Maryland (2), Florida (2), North Carolina (1) and Indiana (1) -- have
contracted fungal meningitis, and 5 of them have died, according to
the CDC. All had received steroid shots for back pain, a highly common
treatment.
In an alarming indication the outbreak could get a lot bigger,
Massachusetts health officials said the pharmacy involved, the New
England Compounding Center [NECC] of Framingham, MA, has recalled 3
lots consisting of a total of 17 676 single-dose vials of the steroid,
preservative-free methylprednisolone acetate. An unknown number of
those vials reached 75 clinics and other facilities in 23 states
between July 2012 and September 2012, federal health officials said.
Several hundred of the vials, maybe more, have been returned unused, a
Massachusetts official said.
But many other vials were used. At a clinic in Evansville, Indiana,
more than 500 patients got injections from the suspect lots, officials
said. At 2 clinics in Tennessee, more than 900 patients, perhaps many
more, did.
The investigation began about 2 weeks ago after a case was diagnosed
in Tennessee. The time from infection to onset of symptoms is anywhere
from a few days to a month, so the number of people stricken could
rise.
Investigators this week found contamination in a sealed vial of the
steroid at the New England company, according to FDA officials. Tests
are under way to determine if it is the same fungus blamed in the
outbreak. The company has shut down operations and said it is working
with regulators to identify the source of the infection.
"Out of an abundance of caution, we advise all health care
practitioners not to use any product" from the company, said Ilisa
Bernstein, director of compliance for the FDA's Center for Drug
Evaluation and Research.
The type of fungal meningitis involved is not contagious like the more
common forms. It is caused by a fungus often found in leaf mold and is
treated with high-dose antifungal medications, usually given
intravenously in a hospital. The common mold _Aspergillus_ was
cultured from 5 patients, the CDC said Thursday [4 Oct 2012].
The New England company is what is known as a compounding pharmacy.
These pharmacies custom-mix solutions, creams, and other medications
in doses or in forms that generally aren't commercially available.
Other compounding pharmacies have been blamed in recent years for
serious and sometimes deadly outbreaks caused by contaminated
medicines. Compounding pharmacies are not regulated as closely as drug
manufacturers, and their products are not subject to FDA approval.
A national shortage of many drugs has forced doctors to seek
custom-made alternatives from compounding pharmacies. The New England
company at the center of the outbreak makes dozens of other medical
products, state officials said. But neither the company nor health
officials would identify them.
The company said in a statement Thursday [4 Oct 2012] that despite the
FDA warning, "there is no indication of any potential issues with
other products." It called the deaths and illnesses tragic and added:
"The thoughts and prayers of everyone employed by NECC are with those
who have been affected."
A 2011 state inspection of the Framingham facility gave the business a
clean bill of health.
[Byline: Mike Stobbe]
- --
Communicated by:
ProMED-mail
<promed@promedmail.org>
Fungal Meningitis Outbreak Grows, 5 Dead
Posted: 10/04/2012
October 4, 2012 — Federal health officials warned healthcare providers Thursday to immediately stop using any products from the New England Compounding Center (NECC) in Framingham, Massachusetts, the company that made the injectable medication linked to a deadly outbreak of fungal meningitis that appears to be growing.
"We are urging health providers to check their drug supply and purchase records to determine if they have purchased any products from NECC, immediately discontinue use and isolate those products from their supply," Ilisa Bernstein, PharmD, JD, director of the Office of Compliance, Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA), said during a telephone briefing with reporters.
On September 21, the Centers for Disease Control and Prevention (CDC) was notified by the Tennessee Department of Health of a patient with the onset of meningitis roughly 19 days after epidural steroid injection at a Tennessee ambulatory surgery center. All initial cultures for cerebrospinal fluid (CSF) and blood were negative for any potential infection. Subsequently, the patient had a fungus isolated from CSF by fungal culture.
On September 28, investigators identified a similar case outside of Tennessee, "possibly indicating contamination of a widely distributed medication," Benjamin Park, MD, medical officer of the Mycotic Diseases Branch at CDC said.
As of October 4, a total of 35 cases in 6 states have been identified with a clinical picture consistent with fungal infection. At least 5 patients have died. Fungus has been identified from specimens in a total of 5 patients so far.
All infected patients received preservative-free methylprednisolone acetate from 3 now-recalled lots of the steroid injection compounded and distributed by NECC.
Dr. Bernstein reported that FDA has detected fungal contamination by direct microscopic examination of particulate matter taken from a sealed vile of methylprednisolone acetate injection collected from NECC. "FDA is in the process of further identifying the fungal contaminate. Foreign material has also been observed in other vials produced by the company that were collected by FDA during an inspection. Additional microbial testing is underway," she said.
Ongoing Investigation
"As of October 3, NECC has voluntarily shut down all operations and expanded its recall to include all methylprednisolone acetate prepared by NECC as well as all other drug products for intrathecal administration prepared by NECC. FDA will post this expanded recall on our website as soon as it is available," Dr. Bernstein added.
"While these are significant steps toward containing the potentially contaminated drug products, out of abundance of caution, FDA is taking the additional steps of advising health care providers not to use any product that originated from NECC until the investigation into the source of the outbreak is complete and further information is provided," Dr. Bernstein said.
She emphasized that the investigation into the source of the outbreak is ongoing, but given the severity of the illnesses seen so far, "we believe these precautionary measures are warranted to protect the public health."
Dr. Park report reported that infected patients have typically presented 1 to 4 weeks after injection with a variety of symptoms, including fever, new or worsening headache, nausea, and/or new symptoms consistent with stroke.
The CDC is urging healthcare providers to contact all patients who received steroid injections using product from any of the 3 recalled lots to determine whether they are having symptoms. "Patients may be experiencing mild symptoms not typical of meningitis. Even patients with mild symptoms should be evaluated immediately," Dr. Park said.
Furthermore, although the CDC is aware only of infections occurring in patients who received epidural steroid injections, people who received other types of injections of methylprednisolone acetate from the 3 lots should also be contacted to assess for signs of infection, Dr. Park said.
"This is an ongoing investigation," Dr. Park said, "and unfortunately, despite the current recall, we expect to see additional cases as this investigation unfolds. However, it is possible that if patients are identified soon and started on appropriate antifungal therapy some of the unfortunate consequences may be averted."
About 75 facilities in 23 states have received shipments of the potentially contaminated steroid product from NECC: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia.
CDC and FDA are continuing to work with state health departments on this "challenging investigation," Dr. Park said.
© 2012
Medscape Medical News © WebMD, LLC
Heartwire © WebMD, LLC
WebMD Health News © WebMD, LLC
Reuters Health Information ©
Send comments and news tips to news@medscape.net.
沒有留言:
張貼留言