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zoom RSS ステロイド注射に関連した致死性の真菌性髄膜炎が急増/米国医療事情

<<   作成日時 : 2012/10/08 23:45   >>

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ステロイド注射に関連した致死性の真菌性髄膜炎が急増/米国医療事情
画像 CDCによれば9州で91人が発症し7人が死亡したという。ミシガンで20例、バージニアで18例となった。マサチューセッツのNew England Compounding Center社が、7〜9月にかけて23州の76施設にメチルプレドニゾロン酢酸17676バイアルを出荷したと保健当局は発表している。背部痛に鎮痛剤として数千人に注射された。髄膜炎は、脳と脊髄を覆う膜の感染症であり、注射後1週間から4週間からさまざまな症状が出現した。
 フロリダ州、インディアナ州、メリーランド州、ミシガン州、ミネソタ州、ノースカロライナ州、オハイオ州、テネシー州、バージニア州の9州で真菌性髄膜炎の症例が報告されている。発生が最初に検出されたテネシー州では、3例の死亡例を含む、32例が発症し、多くの患者は危篤状態で入院したままである。


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Deadly meningitis outbreak increases to 91 cases
http://www.reuters.com/article/2012/10/07/us-meningitis-idUSBRE89412420121007

By Tim Ghianni
NASHVILLE, Tennessee | Sun Oct 7, 2012 6:23pm EDT
(Reuters) - U.S. health officials on Sunday reported an additional 27 cases in a fungal meningitis outbreak linked to steroid injections that has killed seven people and now infected 91 in nine states.

The U.S. Centers for Disease Control and Prevention reported the new total of 91 cases in an update on its website, up from 64 on Saturday. Most of the new cases were reported in Michigan, where the total increased to 20 from eight. Virginia's total increased to 18 from 11.

The widening outbreak has alarmed U.S. health officials and focused attention on regulations of pharmaceutical compounding companies like the one that produced the drugs, the New England Compounding Center Inc in Framingham, Massachusetts.

The company shipped 17,676 vials of the steroid methylprednisolone acetate to 76 facilities in 23 states from July through September, the Massachusetts Health Department said.

The steroid is used as a painkiller, usually for the back, and could have been injected in thousands of patients, authorities have said.

Meningitis is an infection of the membranes covering the brain and spinal cord, and affected patients started showing a variety of symptoms from one to four weeks after their injections.

The company, which was previously the subject of complaints, has suspended its operations while an investigation proceeds and earlier recalled the three lots of the drug. It expanded its recall on Saturday to all products compounded and distributed at its Framingham facility.

According to an announcement on its website, the company issued the broader recall out of "an abundance of caution" because of the "potential risk of contamination."

A compounding pharmacy takes medications from pharmaceuticals manufacturers and makes them into specific dosages and strengths for use by doctors.

Complaints against the company in 2002 and 2003 about the processing of medication resulted in an agreement with government agencies in 2006 to correct deficiencies, the Massachusetts Health Department said.

LIMITED FDA AUTHORITY

In 2011, there was another inspection of the facility and no deficiencies were found. In March 2012, another complaint was made about the potency of a product used in eye surgery procedures. That investigation is continuing, the state health department said.

The U.S. Food and Drug administration has limited authority over the day-to-day operations of compounding pharmacies, which are regulated primarily by state boards that oversee the practices, licensing and certification of pharmacies and pharmacists.

Compounded products do not have to win FDA approval before they are sold, and the agency has no jurisdiction over how the products are manufactured or labeled for use. Instead, the FDA investigates cases of adulterated drugs in cooperation with state regulators.

The FDA has tried to exert greater authority over compounded drug products under a section of the Food, Drug and Cosmetic Act that covers new drugs. But those efforts led to federal court challenges that resulted in two separate and conflicting rulings at the appellate level.

The nine states where fungal meningitis cases have been reported are Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia.

Tennessee, where the outbreak was first detected, accounted for most of the cases, with 32, including three deaths. Many patients there remain hospitalized, some in critical condition.

Michigan had 20 cases and two deaths. One person died in Maryland and another in Virginia, the CDC said.

Reuters had reported 65 cases on Saturday, including one additional case after the CDC published its total.

Fungal meningitis is not contagious, the CDC said. Symptoms include fever, headache, nausea and neurological problems that would be consistent with deep brain stroke.

The steroid was sent to 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, Texas, Virginia and West Virginia, the CDC said.

A list of facilities that received vials from the infected lots can be found via the website cdc.gov. (Additional reporting by David Morgan and Karen Brooks; editing by Daniel Trotta and Mohammad Zargham)

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Scant Oversight of Drug Maker in Fatal Meningitis Outbreak
By DENISE GRADY, ANDREW POLLACK and SABRINA TAVERNISE
Published: October 6, 2012
http://www.nytimes.com/2012/10/07/us/scant-drug-maker-oversight-in-meningitis-outbreak.html

Eddie C. Lovelace, a Kentucky judge still on the bench into his late 70s, had a penchant for reciting Shakespeare from memory and telling funny stories in his big, booming voice. But a car accident last spring left him with severe neck pain, and in July and August he sought spinal injections with a steroid medicine for relief.

Instead, Judge Lovelace died in Nashville in September at age 78, one of the first victims in a growing national outbreak of meningitis caused by the very medicine that was supposed to help him. Health officials say they believe it was contaminated with a fungus.

The rising toll ? 7 dead, 57 ill and thousands potentially exposed ? has cast a harsh light on the loose regulations that legal experts say allowed a company to sell 17,676 vials of an unsafe drug to pain clinics in 23 states. Federal health officials said Friday that all patients injected with the steroid drug made by that company, the New England Compounding Center in Framingham, Mass., which has a troubled history, needed to be tracked down immediately and informed of the danger. ----


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Multistate Meningitis Outbreak Investigation
October 7, 2012 7:30 PM EDT

CDC is aware that New England Compounding Center has voluntarily expanded its recall to include all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts.
CDC's guidance to patients has not changed as a result of this voluntary recall. Patients who feel ill and are concerned about whether they received a medication from NECC should contact their physicians.
Clinicians should actively contact patients who have received medicines associated with three lots of preservative-free methylprednisolone acetate (80mg/ml) recalled on September 26. The potentially contaminated injections were given starting May 21, 2012. Symptoms that should prompt diagnostic evaluation include: fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site.

Summary:

CDC is coordinating a multistate investigation of meningitis among patients who received epidural steroid injections (medication injected into the spine). Several of these patients have had strokes related to the meningitis. In several patients, the meningitis was found to be caused by a fungus that is common in the environment but rarely causes meningitis. This form of meningitis is not contagious. The source of the fungus has not yet been identified, and the cause of infections in the other patients is still being assessed.

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