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Old 10-08-2012, 09:39 PM
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Arrow Meningitis-linked steroid may have affected 13,000 people in U.S.: CDC

Meningitis-linked steroid may have affected 13,000 people in U.S.: CDC

(Reuters) - Some 13,000 people in 23 U.S. states may have received steroid injections linked to a rare fungal meningitis outbreak that has killed eight people, but far fewer are likely to contract the disease, the Centers for Disease Control said on Monday.


The CDC for the first time estimated the number of patients potentially affected, after previously saying only that it could be in the thousands.


More:
http://uk.reuters.com/article/2012/1...8970TQ20121008
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Old 10-09-2012, 10:54 AM
Summerthyme Summerthyme is offline
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This is INSANE. That was NOT a "compounding pharmacy" by ANY reasonable definition of the term- it was an unlicensed, substandard drug manufacturing plant!

Tragically, this whole mess will likely make true compounding pharmacies (where licensed pharmacists compound SMALL individual batches for single customers as needed) have to meet new, onerous (and unnecessary) regulations, or simply put them out of business.

Which means a bunch of people who really NEED the meds they can only get from one of them will be out of luck- thanks to some greedy b***ards carelessness.

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Old 10-09-2012, 11:36 AM
MsPaulRevere MsPaulRevere is offline
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I would like to see more info on this so called compounding pharmacy. Who owns it and what works there. I smell sabotage which equals murder of americans.
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Old 10-09-2012, 11:47 AM
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Quote:
Originally Posted by MsPaulRevere View Post
I would like to see more info on this so called compounding pharmacy. Who owns it and what works there. I smell sabotage which equals murder of americans.
Some of us smell a company that has just gotten greedy and not maintained the required standards...


Story from Boston paper:

Quote:

13,000 may be at risk of meningitis

Patients in 23 states given steroid from Mass. firm that is tied to outbreak


By Kathy McCabe

Globe Staff / October 8, 2012

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US health officials said Monday that 13,000 patients in 23 states, including Connecticut, New Hampshire, and Rhode Island, have been injected with a potentially tainted steroid treatment made by a Framingham pharmacy and linked to a national outbreak of meningitis.



Related
•Mich. man at risk for meningitis after losing wife
•Mass. lawmaker: We're keeping eye on outbreak
•Docs say spine shots for steroids are usually safe
•Intense pain, confusing diagnosis mark meningitis
•Graphic: Case count of meningitis outbreak
•Fungi blamed for meningitis rarely cause trouble
•10/7: Framingham pharmacy recalls all its products as meningitis cases nearly double
•10/5: Compounding pharmacy oversight is questioned
•What is meningitis?
•Waiting, worrying amid deadly meningitis outbreak


The US Centers for Disease Control and Prevention gave its sweeping estimate of the reach of the crisis as it reported 14 new cases of the disease, and another death in Tennessee, which appears to be the hardest hit among the states where the rare and serious form of fungal meningitis has been confirmed.


“We know that 13,000 people received the injection,” said Jamila Jones, a public affairs specialist for the CDC in Atlanta. “They received it at facilities across the country. They are at risk.”


So far, 105 cases and eight deaths have been confirmed nationally, the agency said.


The steroid, called methylprednisolone acetate, was made by New England Compounding Center in Framingham, which voluntarily ceased operations Oct. 3 amid a widening investigation of the steroid and its use at dozens of health care facilities from New Hampshire to California. The injection is typically used to treat back pain.


A spokesman for New England Compounding Center on Monday said the company would have no further comment on the matter.


In New Hampshire, concern about a meningitis outbreak is growing. More than 200 patients treated at the Merrimack and Somersworth offices of Dr. O’Connell’s Pain Management Center received injections from mid-June until Sept. 27, Dr. Michael O’Connell said Monday night.


A handful of patients, who have complained of headaches, numbness, and other symptoms of meningitis, are being observed in local hospitals, O’Connell said.


“We are watching them very carefully,” he said in an interview. “We are just at the beginning of this. If a contaminated medication with the fungus is injected, it could be a week or four weeks” before the disease is diagnosed.


On Saturday, the company voluntarily recalled all 1,200 products made at its facility on Waverly Street. It posted a 71-page list of the products recalled, which includes some common drugs and medications, such as the pain reliever acetaminophen, blood-pressure medication clonidine, rubbing alcohol, and mouthwash.


“This action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Massachusetts Board of Registration in Pharmacy,” the company wrote in a statement published on its website, neccrx.com.


The recall followed an announcement by the US Food and Drug Administration on Oct. 5 that it was investigating an outbreak of meningitis among patients who had received an injection of the steroid in their spine. The FDA said fungal contamination was detected in foreign matter taken from a sealed vial of the steroid collected from NECC. The agency also recommended that health care facilities and consumers not use any product made by the Framingham company.


According to the CDC, the steroid was shipped to 75 health care facilities in 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.


Most cases and fatalities so far have been reported in the South and Midwest.


In Tennessee, 35 meningitis cases and four deaths, including one over the weekend, were confirmed. The high rate is probably linked to a large shipment of the steroid treatment shipped to health care facilities there, Dr. John Dreyzehner, the state’s public health commissioner, said Monday.


“We received a disproportionate share of the NECC compound,” Dreyzehner said in an afternoon conference call with reporters. “It’s unfortunate, but that is indeed what happened.”


After Tennessee, Virginia had the second-highest number of confirmed cases with 23, followed by Michigan, 21; Indiana, 11; Maryland, five; Florida, four; Minnesota, three; North Carolina, two; and Ohio, one, according to the CDC.


Dreyzehner said the outbreak was first identified in Tennessee by public health officials at the St. Thomas Outpatient Neurosurgery Center in Nashville, which received 2,000 vials of the steroid, more than any other facility in the state.


About 1,000 people in Tennessee have been identified as having received the steroid treatment since June 27, Dreyzehner said. Over the weekend, the state sent public health nurses knocking on doors at patients’ homes to notify them that they may be at risk, if they were already not aware, he added.Continued...


Kathy McCabe can be reached at kmccabe@globe.com. Follow her on Twitter @GlobeKMcCabe.
Info on New england Componding Center....

http://www.neccrx.com/


links at this link..

Quote:
October 6, 2012

New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center (NECC) today announced a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. This action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained and secured. While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that can be accessed here. A complete list of all products subject to this recall can be accessed here.

NECC is notifying its customers of this recall by fax. Clinics, hospitals and healthcare providers that have product which is being recalled should stop using the product immediately, retain and secure the product, and follow instructions contained in the fax notice.

Adverse reactions or quality problems experienced with the use of any product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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