Tainted Steroid Drugs Caused Deadly Meningitis Outbreak

CDC says 13,000 patients could be at risk from tainted steroid made by Framingham com

CDC says 13,000 patients could be at risk from tainted steroid made by Framingham company

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

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 specilialist 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 probe of the treatment and its use at dozens of health care facilities from New Hampshire to California.

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

On Saturday, the company voluntarily recalled 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 to treat back pain. 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 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.
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http://www.boston.com/metrodesk/201...ham-company/xSOOpswxnMcYqMipuIocFP/story.html
 
On Saturday, the company voluntarily recalled 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.
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What. The. Fuck. This company should have its FDA license pulled.

How the hell do you have such rampant and unchecked fungal contamination in a supposedly sterile product line is beyond me. Now the execs have the lives of a bunch of meningitis victims to account for. Fuckers.
 
Company linked to meningitis scare besieged as deaths rise

The company that produced
contaminated medications linked to an unprecedented fungal
meningitis outbreak faced mounting scrutiny on Saturday over
whether it illegally sold drugs to medical facilities, as the
death toll from the disease grew to 15.

The Centers for Disease Control and Prevention (CDC) said
another person died from meningitis, the second death in
Indiana. The number of cases of the disease reported reached
201 in 14 states, according to the CDC and state officials.

http://www.chicagotribune.com/sns-r...-pix-graphicl1e8ld2uy-20121013,0,457570.story
 
Meningitis Outbreak: 2 More Drugs Probed


Two other drugs made by the New England Compounding Center (NECC) appear to be involved in the fatal meningitis outbreak that has now claimed the lives of 15 people in as many states, the FDA announced Monday.

The FDA said today it is investigating one case of possible meningitis associated with an epidural injection of triamcinolone acetonide and two reports of fungal infection with Aspergillus fumigatus in two transplant patients who were given cardioplegic solution made by the company.

The solution is used to paralyze the cardiac muscle during open-heart surgery.

cont at
http://abcnews.go.com/Health/Wellness/meningitis-outbreak-drugs-probed/story?id=17484597
 
FDA: Mold seen in 83 vials of the steroid linked to fungal meningitis outbreak

The US Food and Drug Administration found visible mold inside the Framingham pharmacy at the center of the national fungal meningitis outbreak, including 83 vials from one lot of the tainted steroid used to treat back pain that contained “greenish black foreign matter.’’

An additional 17 vials in that bin of 321 vials of methylprednisolone acetate had white fibers floating in them during the inspection. FDA investigators visited New England Compounding Center over seven days between Oct. 1 and Oct. 26, which was after the steroid was recalled by the company.

Other vials from this lot had already been sent out to clinics around the country, to be used for back and joint injections, between Aug. 17 and Sept. 25.

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http://www.boston.com/whitecoatnote...is-outbreak/TaUeg5iz5PWUaLEedmhdAI/story.html
 
What a bunch of irresponsible fuckers. They have be held accountable for this, not with ridiculous fines, but with actual jail terms. How the hell could this happen??
 
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