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Old 10-03-2012, 04:17 PM   #1
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Default Outbreak of rare form of fungal meningitis associated with epidural steroid injections

Info on this started coming out a couple of days ago here in TN. At first, it seemed to be local but it's breaking wide open today with the announcement that cases have been found in 5 states.

"Four dead, 26 sick from suspected fungal meningitis as outbreak worsens"

Quote:
"Four people have died and 22 more made sick by meningitis linked to a rare fungal infection blamed on contaminated steroids, health officials said on Wednesday. They are “almost certain” more will be identified before it’s over.

The 26 cases include 18 people in Tennessee, one in North Carolina, two in Florida, three in Virginia and two in Maryland, the U.S. Centers for Disease Control and Prevention reported. Two of the deaths were in Tennessee, one in Virginia and one in Maryland.

The chief suspect is contaminated vials of a pain treatment injected directly into the spine. The drug, called methylprednisolone acetate, was made by a compounding pharmacy – one that makes drugs to order. The suspected batches were made without any preservatives.

...“We have notified medical professionals the prime suspect for this outbreak is methylprednisolone acetate and we have identified the compounding center involved,” Dreyzehner told reporters in a telephone briefing. He declined to name the center and it was not yet clear how widely the drug was distributed.

...“The type of meningitis we are dealing with in this situation is not communicable person to person,” Dreyzehner said.

The 18 Tennessee cases are associated with Tennessee centers - Saint Thomas Outpatient Neurosurgery Center in Nashville, a center in Crossville, and now a third center in Oak Ridge, the officials said. The cases were all injected from two lots of steroids.

...The CDC and FDA are testing samples of the drug, which has been recalled nationwide, as well as samples from the patients to be sure it’s aspergillus. Aspergillus has not been isolated yet from the steroid."
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Old 10-03-2012, 06:58 PM   #2
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The producer of the drug suspected to be contaminated has been identified. And, in another example of what has become typical for the FDA, the company was informed of the issue on Sept. 26th, although the public was NOT informed until some days later.

WebMD: 26 Cases, Hundreds of Possible Infections in Outbreak of Rare Fungal Meningitis

Quote:
"Four people have died in an outbreak of a rare fungal meningitis linked to contaminated spinal steroid injections.

So far there are 26 known cases in five states: Tennessee (18 cases, two deaths), North Carolina (one case, no deaths), Florida (two cases, no deaths), Virginia (three cases, one death), and Maryland (two cases, one death).

"New cases are almost certain to be identified," Tennessee Health Commissioner John J. Dreyzehner, MD, MPH, said today in a news teleconference.

The infections were traced to steroid injections (methylprednisolone acetate) made by a single compounding pharmacy: The New England Compounding Center (NECC).

"FDA is working with several state health departments and is still investigating the scope and cause of the outbreak of fungal meningitis," FDA spokeswoman Erica Jefferson tells WebMD.

One Sept. 26, the NECC recalled three suspect lots of the medication. The action was not made public, but clinics that ordered the steroid were notified.

The clinics that gave the shots -- a common treatment for inflammation-related back pain -- have been frantically calling patients to warn them they might be infected. It's not clear how many patients are involved.


The first of the three suspect lots of medication were given to 737 patients in Tennessee alone. Since then, two more lots of the steroid have been recalled. One of the Tennessee clinics had 2,000 vials of the tainted medication, thought to be the largest single supply in the U.S.

...The contaminant in the steroid shots is a fungus called Aspergillus fumigatus."
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Old 10-04-2012, 12:41 PM   #3
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AP is reporting that New Jersey has found 6 facilities that received the medication under investigation. None have been named as of yet. The facilities are in the process of contacting patients.

Although the steroid compound has been identified as the most likely source of the infection, NBC News is reporting that:

Quote:
"Health officials are not entirely certain the steroid is to blame, said the Tennessee health department’s Dr. Marion Kainer. The health officials, the CDC and the FDA are testing the pain medications and other materials used with the steroid injections, as well as samples from the patients. Patients were also treated with injections of lidocaine and a povidone iodine skin preparation solution, the CDC said."
A statement from the Mass. Dept. of Public Health mentions that there are 4 products common to all the cases, but doesn't specify what they are.
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Old 10-04-2012, 09:47 PM   #4
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"No preservatives in injections! We are going to sue!"

Later

"What? No preservatives in the injections? We are going to sue!"
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Old 10-04-2012, 10:07 PM   #5
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As predicted, the numbers are growing.

"Medication tied to rare meningitis outbreak may have reached 23 states"


Quote:
"A steroid medication linked to the death of at least five people from rare fungal meningitis may have been administered to patients in 23 states, the U.S. Centers for Disease Control said on Thursday, raising fears the rare outbreak could spread.

In a briefing for reporters, the CDC said five people had died so far and 35 had fallen sick from fungal meningitis in six states.

...The CDC said it had not yet determined the rate of infection among those patients who received the potentially tainted steroid. The rate of infection is an important barometer of the potential for the outbreak to spread.

"At the moment, fortunately, the attack rate looks pretty low - less than 1 percent -- but we are still in the early days of defining this thing," Schaffner said.

...The Massachusetts Health Department said there were 17,676 vials of medication in each of the three lots under investigation. They were sent out July through September and have a shelf life of 180 days.

The CDC said the fungal contamination was detected in the examination of one of the sealed vials taken at that company.

Patients who received the injections were at risk of developing fungal meningitis for at least a month after their last exposure, Schaffner said.

"There is a fairly long incubation period. ... That hasn't run out yet for many patients," Schaffner said.

"Over the next few weeks, we are going to see a progressive accumulation of cases," he said.

...About 75 facilities could have received the steroid in the 23 states. They are 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, according to Park.

One facility in Indiana, St. Mary's Health, said on Thursday that 560 patients had received the recalled medication. They received the steroid at the Surgicare Cross Pointe clinic in Evansville, said St. Mary's spokeswoman Laura Forbes."
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Last edited by Catbird; 10-04-2012 at 10:07 PM. Reason: stooopid brackets
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Old 10-05-2012, 02:25 PM   #6
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The case count has increased.

Twitter:
"4 patients of Minnesota pain clinics show meningitis symptoms, sent for testing - @StarTribune"


And 4 more cases confirmed in TN:
"Fungal meningitis infection toll rises to 29 in Tennessee - @Tennessean"


CDC has issued a HAN Advisory on this and set up a page for further info.


HAN Summary
:

Quote:
"Meningitis and Stroke Associated with
Potentially Contaminated Product
Summary
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are coordinating a multi-state investigation of fungal meningitis among patients who received an epidural steroid injection. Several of these patients also suffered strokes that are believed to have resulted from their infection. As of October 4, 2012, five deaths have been reported. Fungal meningitis is not transmitted from person to person. These cases are associated with a potentially contaminated medication. Investigation into the exact source is ongoing; however, interim data show that all infected patients received injection with preservative-free methylprednisolone acetate (80mg/ml) prepared by New England Compounding Center, located in Framingham, MA."
CDC website for further specific info: Multistate Meningitis Outbreak
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Old 10-05-2012, 03:37 PM   #7
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And still climbing...

"Centers for Disease Control: Number of confirmed US fungal meningitis cases rises to 47 in 7 states; no new deaths - @Reuters"

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Last edited by Catbird; 10-05-2012 at 03:39 PM. Reason: details, details...
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Old 10-05-2012, 06:05 PM   #8
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CDC has just posted a list of the facilities nationwide that received shipments of the contaminated lots. I don't know if the list is complete.


"List of Healthcare Facilities which Received Lots of Methylprednisolone Acetate (PF) Recalled from New England Compounding Center on September 26, 2012"
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Old 10-05-2012, 07:44 PM   #9
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FDA expands recall list of tainted drugs as meningitis outbreak grows to 47 cases

http://www.foxnews.com/health/2012/1...to-meningitis/
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Old 10-05-2012, 08:00 PM   #10
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Official FDA list can be found at:

"List of Recalled Products Related to Fungal Meningitis Outbreak"
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Old 10-05-2012, 08:09 PM   #11
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Now 6 cases confirmed in MI, with the number "expected to increase".

WDIV:
"Michigan joins list of states with cases of rare fungal meningitis, confirms 6 cases tied to national outbreak"

Quote:
"On Friday, Michigan joined the list, with six reported cases of fungal meningitis tied to the national outbreak. Local 4 has learned the meningitis patients are being treated at St. Joseph Mercy Hospital in Ann Arbor.

...The steroids were delivered to four facilities in Michigan. The Michigan Department of Community Health says the number of cases is expected to increase."
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Old 10-06-2012, 12:10 AM   #12
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I just received this warning from the State of VA:

October 5, 2012

MENINGITIS AND STROKE ASSOCIATED WITH POTENTIALLY CONTAMINATED PRODUCT

Dear Colleague,

This letter includes updated information regarding a multistate outbreak of fungal meningitis associated with epidural spinal injections. While the investigation into the source of the infection is ongoing, all infected patients received preservative-free methylprednisolone acetate from three lots that have been voluntarily recalled by the New England Compounding Center, located in Framingham, Massachusetts. This product of concern was distributed to 23 states.

Virginia Department of Health (VDH) is working closely with the only two medical facilities known to have received and used this product from this manufacturer. Both facilities have contacted their patients who received this medication via any route of injection between July 2012 and September 2012. Insight Imaging in Roanoke contacted more than 600 patients and New River Valley Surgery Center in Christiansburg contacted less than 30 patients.

As of October 4, 2012, CDC is reporting 35 cases from 6 states with a clinical presentation consistent with fungal infection. Aspergillus fumigatus was isolated in CSF from one patient; fungal isolates from other patients are being evaluated. Tragically, these numbers include 5 deaths. In Virginia, 4 cases, including 1 fatal case, have been identified. Nationwide and in Virginia, additional suspect cases are being evaluated by their physicians and investigated by public health.

While only two facilities in the state are known to have received and used this product, we believe broad awareness of this cluster is indicated. Attached are the CDC Health Alert summarizing the outbreak, case definitions, diagnostic guidance, and interim treatment recommendations. Please review these documents and consider the information, particularly if you see patients who present with signs or symptoms of meningitis or basilar stroke and had a recent epidural spinal injection at one of the two facilities. Of note, presenting symptoms of some patients with meningitis have been mild and not classic for meningitis (e.g., new or worsening headache without fever or neck stiffness). CDC is encouraging physicians to have a low threshold for performing a diagnostic lumbar puncture (LP) in patients who received the implicated methylprednisolone product by spinal injection.

Once again, medical and public professionals in Virginia are working together to stop an outbreak by identifying those at risk and providing them with care to prevent morbidity and mortality. Thank you.

If you need more information or have questions regarding this situation, please call your local health department, www.vdh.virginia.gov/LHD. VDH will continue to provide new information as it becomes available, www.vdh.virgina.gov, and daily updates will be provided by the CDC, http://www.cdc.gov/HAI/outbreaks/meningitis.html.
Sincerely,

Karen Remley, MD, MBA, FAAP
State Health Commissioner
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Old 10-06-2012, 03:05 PM   #13
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New numbers from the CDC this afternoon. Confirmed cases now in 9 states, and the death toll is up to 7.



CDC Meningitis Outbreak by State
:
Quote:
Total case count: 64

Florida: 4 cases
Indiana: 5 cases
Maryland: 3 cases, including 1 death
Michigan: 8 cases, including 2 deaths
Minnesota: 1 case
North Carolina: 2 cases
Ohio: 1 case
Tennessee: 29 cases, including 3 deaths
Virginia: 11 cases, including 1 death
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Old 10-07-2012, 04:45 AM   #14
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I wonder if this is what was wrong with my leg.... in july I had the same drug injected in my leg for my epidermal inflammation ... and I ended up in the hospital... scary
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Old 10-07-2012, 11:11 AM   #15
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KG, you should remind your doctor of this. I'm sure that the CDC & FDA are trying to track this back as to the beginning of the problem.

The FDA webpage says

Users should also notify FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by phone at 1-800-FDA-1088 or on line at www.fda.gov/medwatch/report.htm.
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Old 10-07-2012, 03:58 PM   #16
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New case count from CDC as of 2pm today:

Case count: 91
Deaths: 7
States: 9

Quote:
By state:
Total case count: 91

Florida: 4 cases
Indiana: 8 cases
Maryland: 3 cases, including 1 death
Michigan: 20 cases, including 2 deaths
Minnesota: 3 case
North Carolina: 2 cases
Ohio: 1 case
Tennessee: 32 cases, including 3 deaths
Virginia: 18 cases, including 1 death

2 separate fungi have been identified in the suspect vials.

From NBC News:

Quote:
"Fungus has been identified in specimens obtained from 9 patients, including Aspergillus and Exserohilum," CDC said. Both types of fungus are found in back yards -- Exserohilum can cause leaf spot but it's also been linked to skin and sinus infections. Aspergillus causes lung infections in cancer, HIV and other patients with suppressed immune systems.

Some kind of fungal contaminant has been found in at least one vial of drugs made by the pharmacy. Fungi can grow in drugs that are not stored properly, especially those without preservatives, like those made by the compounding pharmacy.

Meningitis is an inflammation of the spinal cord, usually caused by bacteria or viruses. It can be very serious and symptoms include headache, fever, often a stiff neck and balance problems. Fungi and parasites can also cause this inflammation and in this case the common mold aspergillus is suspected.

Fungal infections are tricky to treat. Antifungal drugs including voriconazole and amphotericin can be used to treat the infections.

"Currently, we think that this type of meningitis is quite severe as we have been describing here. The antifungal treatment for this is intravenous antifungal treatment and requires initial hospitalization. But the duration of antifungal therapy could be prolonged, possibly on the order of months," Park said.


From new CDC Clinician Guidance:
Quote:
Case Definitions: Multistate Outbreak Associated with Injection of Potentially Contaminated Steroid Products

October 6, 2012 8:00pm ET

1. A person with meningitis1 of sub-acute onset (1-4 weeks) following epidural injection after May 21, 2012.

2. A person with basilar stroke 1-4 weeks following epidural injection after May 21, 2012, who has not received a diagnostic lumbar puncture.

3. A person with evidence of spinal osteomyelitis or epidural abscess at the site of an epidural injection diagnosed 1-4 weeks after epidural injection after May 21, 2012.

4. A person with septic arthritis3 diagnosed 1-4 weeks following steroid joint injection after May 21, 2012.

1Clinically diagnosed meningitis meaning 1 or more of the following symptoms: headache, fever, stiff neck, or photophobia and a CSF profile consistent with meningitis (pleocytosis +/- low glucose, elevated protein).

2These people, if possible, should have a lumbar puncture.

3Clinically diagnosed septic arthritis meaning new or worsening pain with presence of effusion or new or worsening effusion.
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Old 10-07-2012, 04:33 PM   #17
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In looking at the lot numbers for the recalled contaminated products, they appear to be the date of creation, which means that some of the lots were made as long ago as April 6, 2012!! The oldest lot that was preservative free was made April 16, 2012

List of Recalled Products Related to Fungal Meningitis Outbreak

Lot Numbers

Preservative Free
05212012@68
06292012@26
08102012@51

Preservative Free
05012012@74
06082012@63
07052012@34
08132012@38

Preservative
04242012@91
06272012@7
08082012@103

Preservative Free
04162012@108
05012012@74
06082012@63
07052012@34
08132012@38

Preservative
04062012@44
05222012@13
07302012@72
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Old 10-07-2012, 04:55 PM   #18
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The clinician guidance that I posted above specifies injections received after May 21, 2012. I'm not sure how they came up with that date vs. the April production date that you mentioned.

The incubation period on this varies. In general it is 2 weeks to 1 month but some of the reports mention occasional incidences of a longer period of time.

So, the numbers from a retrospective epidemiological investigation could be pretty high.

This article from "Infection Control Today" quotes the FDA spokesman as saying:

Quote:
"FDA has detected fungal contamination by direct microscopic examination of particulate matter taken from a sealed vial of methylprednisolone acetate injection collected from NECC," says Bernstein. "The FDA is in the process of further identifying the fungal contaminant. Foreign material also has been observed in other vials produced by the company that were colelcted by the FDA during an inspection.
It's pretty damn scary that "foreign material" could be observed in vials. To me, that calls into question ANYTHING made by this company. Apparently the FDA agrees as yesterday the New England Compounding Center recalled ALL products made by them that are currently in circulation.

It's going to take a long time and lots of work to track down all the people who may have been given doses of all of these products. At this point, there's no telling how many incidences of stroke or undiagnosed meningitis may have occurred over the past several months.
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Old 10-07-2012, 06:31 PM   #19
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W.T.F........... 91 sick 7 dead thousands at risk. link below
http://www.dailymail.co.uk/news/arti...=feeds-newsxml
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Old 10-07-2012, 07:06 PM   #20
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Were the three lots mentioned above only used for spinal injections?
No. These medications were used for other types of injections, including injections into the joint (e.g., knee). To date, CDC has only identified infections in patients who received epidural steroid injections with these medications. However, patients who received other types of injections with these products may also be at risk.

What states have received the potentially contaminated medication?
Twenty-three states have received medication from the New England Compounding Center:
  • 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
  • West Virginia
The names of the facilities that have received medication from one of these lots are available at http://www.cdc.gov/hai/outbreaks/men...ities-map.html.
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Old 10-07-2012, 08:07 PM   #21
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NECC has published a list of all products that they have produced since January of 2012. While there has not yet been any confirmation of problems with any products besides those already publicly identified by the CDC/FDA, NECC has "voluntarily" recalled all products currently in circulation.

The list, a 71 page PDF, can be found at:

List of All Products Manufactured since January 2012
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Old 10-07-2012, 09:05 PM   #22
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the one death in Virginia was a friend and schoolmate of one of my close friends (and bandmate), she was taking care of her husband, who has been suffering from ALS for the last ~20 years... this is all a huge tragedy, not only for the country, but for the families that are suffering...very sad for for this family, as something like this should have been prevented...

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Old 10-08-2012, 02:42 PM   #23
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CDC update as of 2pm: 105 cases, 8 deaths


CASES DEATHS
Florida (FL) 4

Indiana (IN) 11

Maryland (MD) 5 1

Michigan (MI) 21 2

Minnesota (MN) 3

North Carolina (NC) 2

Ohio (OH) 1

Tennessee (TN) 35 4

Virginia (VA) 23 1

TOTALS 105 8




Quote:
"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."
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Last edited by Catbird; 10-08-2012 at 02:43 PM. Reason: stooopid formatting
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Old 10-08-2012, 05:41 PM   #24
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This is the first estimate of potential exposure that I've seen.

"Fungal meningitis exposure may reach 13,000"

Quote:
"The number of people infected with a rare type of meningitis tied to contaminated steroid injections has climbed to 105, federal health officials said Monday. Eight people have died.

The drugs were given starting May 21, much earlier than previously suspected, officials with the Centers for Disease Control and Prevention said. Infections and deaths have been reported in nine states. As many as 13,000 patients may have been exposed to the potentially contaminated drugs recalled from a Massachusetts compounding pharmacy, officials added."
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Old 10-08-2012, 08:25 PM   #25
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That's far more than I'd expected. Foolishly, I had visions of compounding pharmacies still being very small enterprises. Obviously not.
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