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Entries in Fungal Meningitis (15)

Friday
May312013

CDC Opens Multi-State Investigation of Infections After Steroid Injections

iStockphoto/Thinkstock(NEW YORK) -- The Centers for Disease Control and Prevention is investigating steroid products produced by a Tennessee pharmacy after a number of patients who received them developed skin and soft tissue infections.

So far, the CDC acknowledges 20 reports of people who received the preservative-free form of the steroid methylprednisolone acetate (MPA) produced by the Main Street Family Pharmacy in Newbern, Tenn., who have contracted infections. So far, the known infections have been reported in Florida, Illinois and North Carolina. However, according to pharmacy records, similar products were shipped to facilities in 17 states since December 2012.

The products in question are the same as those that were implicated in fungal meningitis infections that were reported in previous months.  However, the prior meningitis infections were linked to products shipped from an unrelated compound in Massachusetts.

The products have been recalled by the pharmacy. As of now there have been no reported cases of meningitis linked to MPA products from the Main Street Family Pharmacy, and none of the reported infections are considered life-threatening.

There was no information available regarding infections caused by products other than the preservative-free MPA. State and local health departments are also working with the CDC and the FDA on the ongoing investigation.

Copyright 2013 ABC News Radio

Thursday
Mar142013

Compounding Pharmacists Await Changes After Meningitis Scandal

Jared Wickerham/Getty Images(NEW YORK) -- Despite efforts to close perceived loopholes that allowed the New England Compounding Center (NECC) to distribute thousands of tainted steroid injections that killed 50 people, questions continue to arise about the future of the compounding industry.

For compounding pharmacist Stephen Bernardi, who owns and runs Johnson Compounding and Wellness Center with his wife in Waltham, Mass., keeping up with the latest news on oversight, inspections and industry standards has been a challenge.  He said he's not sure what compounding pharmacists can expect in the next year.

"We try to read every day, and we see something new every day," said Bernardi.  "I don't think it's very clear. ... We think we're doing the right thing."

Since people started getting sick last fall, 17 different state laws began to make their way through state legislatures, some examining whether accreditation should be mandatory for compounding pharmacies, and others clarifying what constitutes a proper prescription, said David Miller, CEO of the International Academy of Compounding Pharmacists (IACP).

The IACP includes more than 2,700 pharmacists, most of them in the United States, and Miller said many shouldn't need to adhere to the same standards as drug manufactures because they are so small.  

The compounding pharmacists have answered primarily to state pharmacy boards -- rather than the U.S. Food and Drug Administration -- for decades.  As such, FDA inspections have been met with unease and confusion.

"One thing we know is that FDA's inspectors are not often familiar with pharmacy law," Miller said.  "The pharmacy could be legally compliant, following all the laws of the state.  They're not NECC in any way, and they could actually be found out of compliance by the FDA because agencies inspect using manufacturing standards."

FDA spokeswoman Sarah Clark-Lynn said the FDA has been coordinating with state officials to conduct 30 risk-based inspections at compounding pharmacies known to mix large quantities of sterile drugs.  It is also conducting inspections following complaints about "serious adverse events," or when states have requested assistance.

So far, 14 inspections have yielded deficiency findings, which the FDA has published online.  Although inspectors haven't found "greenish black foreign matter," as they found at NECC in October, they posted findings, including how pharmacies had been deficient in practices to maintain sterility, which included keeping skin covered and maintaining proper air flow.

"The FDA's authority over compounding companies is limited but not nonexistent," Clark-Lynn said.  "While the current FDA oversight over compounding pharmacies is limited, the agency continues to use its existing authorities to protect consumers."

But how limited is it?

Bernardi, who has not been visited by the FDA, said he wondered whether compounding pharmacists could refuse an FDA inspection if a state inspector wasn't present.

Although FDA officials normally work with state pharmacy boards, FDA policy states that it should "seriously consider" independent "enforcement action" against compounding pharmacists in certain scenarios, such as when they are compounding large amounts of drugs without a prescription, compounding drugs for third parties for resale or compounding drugs that are copies of existing FDA-approved drugs typically made by drug manufacturers.

However, a 2011 federal court ruling in Texas "prohibited" the FDA from inspecting compounding pharmacies beyond the U.S. Food, Drug, and Cosmetic Act, which specifies that FDA inspectors cannot demand research, financial or sales data from pharmacists who are in compliance with state law unless those pharmacists are manufacturing a new drug.

The 2011 ruling trumped a 2008 ruling that determined the FDA actually did have additional authority over compounding pharmacists because all compounded drugs are new drugs.  As such, the 2011 ruling was considered a win for compounding companies and a loss for the FDA.

Copyright 2013 ABC News Radio

Wednesday
Dec122012

New Fungal Meningitis Cases, Spinal Infections Continue to Baffle Doctors

Hemera/Thinkstock(NEW YORK) -- It's been more than a month since the 42-day risk period for contracting fungal meningitis from tainted steroid injections ended on Nov. 7, but new meningitis cases, spinal infections and other complications continue to arise, even for patients who have already been treated and sent home.

"Here's the perplexing issue," said Dr. Tom Chiller, the deputy chief of the Centers for Disease Control and Prevention's mycotic diseases branch.  "Why are we getting people that early on who are presenting with rip-roaring meningitis, but now, they're presenting 100 days later with focal infections only?  Why the difference?  We don't know."

The CDC reported five new meningitis cases, 39 new spinal infections without meningitis, and three new joint infections within the past week.  One more person has died over the same time period, bringing the death toll to 37.

Up to 14,000 people received the tainted injections produced at New England Compounding Center in Framingham, Mass, which recalled all products and shut down on Oct. 6.  It is now being investigated by the Food and Drug Administration, even though its oversight usually falls under its state's pharmacy board's jurisdiction.  

NECC's owner Bill Cadden invoked the Fifth Amendment and declined to answer questions before Congress on Nov. 14.

It's not clear how the fungus got in the steroid vials, but an FDA investigation revealed that a quarter of the steroid vials in an NECC bin contained "greenish black foreign matter," according to an FDA form released on Oct. 26.  The form went on to identify several clean rooms -- where sterile products are produced -- that had either mold or bacterial overgrowths.

The longest fungal infection incubation period the CDC recorded to date was 120 days, Chiller said.  However, the longest incubation period from a previous fungal meningitis outbreak was 152 days.

"We hope that's the exception, not the rule," Chiller said.  "We hope we're nearing the end of this."

In all, 590 people in 19 states have become ill with meningitis or another infection as a result of the tainted steroid injections manufactured by the New England Compounding Company.  Of those, 368 were fungal meningitis and 192 were spinal infections without meningitis.  Other ailment categories included strokes and joint infections.

Perplexingly, the fungal meningitis case tally reached 475 cases on Nov. 19, but some cases have been reclassified as spinal infections, Chiller said.  The CDC started dividing meningitis cases into meningitis cases and spinal infections only on Nov. 26, causing the meningitis count to drop to 360 (including secondary spinal infections) and the spinal infection count to begin at 128 that day.

Copyright 2012 ABC News Radio

Thursday
Nov082012

Timeline of How Fungal Meningitis Outbreak Unfolded

Hemera/Thinkstock(NEW YORK) -- The fungal meningitis outbreak that sickened 414 people this fall was unprecedented.  First, because only people who received a tainted steroid injection were at risk.  And, second, because the fungus wasn't known for making people sick, let alone causing a deadly inflammatory disease that's killed 31 people so far.

Health officials on the local, state and federal levels had to work together to trace the cause of the outbreak and get the word out to at-risk patients and their doctors.

"All of that coordination -- the right hand knowing what the left was doing -- has made a big difference in how quick we could come to an understanding of what was going on," said Dr. David Reagan, the chief medical officer in Tennessee.

Here is a timeline of how the outbreak played out:

Early September: The first fungal meningitis patients arrived in emergency rooms around the country in early September, but it took a clinician in Tennessee, Dr. April Pettit, to realize her patient with a mysterious illness was the beginning of a public health crisis.  Reagan said she found fungus in the patient's spinal fluid.

Sept. 18: Pettit contacted the Tennessee Department of Health, including Dr. Marion Kainer, looking for similar patients.  Her call set the investigation into motion, and she noted that the patient had recently received an epidural steroid injection.

Sept. 20: Two days later, the state health department called the Centers for Disease Control and Prevention to report a fungal infection, noting that the patient had received an epidural steroid injection at the Saint Thomas Outpatient Clinic in August.  Although the CDC had not heard about similar cases, it suggested Kainer visit the clinic.  The same day, the clinic voluntarily closed.  It has not reopened.

Sept. 21: The Tennessee Department of Health narrowed its list of possible causes to tainted steroid injectables from the New England Compounding Center (NECC) in Framingham, Mass., environmental contamination, or mishandling of equipment.

Sept. 24: Several other meningitis cases had been reported, and the Tennessee Department of Health reached out to Massachusetts' Department of health to learn more about NECC.

Sept. 25: The Food and Drug Administration became involved.

Sept. 26: NECC recalled three tainted lots of steroid injections the next day.  The three lots amounted to 17,000 vials that were injected into as many as 1,400 patients, as early as May 21.  Since this was the last day patients could have received steroid injections from NECC, it became day one of the 42-day risk period the CDC began talking about.

The same day, the Massachusetts Department of Public Health began its on-site investigation of NECC.

Oct. 6: There were 64 reported cases of fungal meningitis, and NECC voluntarily recalled all of its products and shut down, pending an FDA investigation.

Oct. 24: The state health department released preliminary findings from its NECC investigation.  Inspectors wrote about dirty floors and a leaky boiler.  Floor mats near sterile drug-mixing areas were "visibly soiled with assorted debris," and a leak from a nearby boiler created an "environment susceptible to contaminant growth," according to the report.

Oct. 26: The FDA released an investigation document, revealing that a quarter of the steroid vials in an NECC bin contained "greenish black foreign matter."  The FDA went on to identify several clean rooms -- where sterile products are produced -- that had either mold or bacterial overgrowths.

Nov. 6: NECC president Barry Cadden was subpoenaed to appear before Congress about the outbreak.

Nov. 7: The 42-day risk period designated by the CDC ended, but five new cases were reported, bringing the total case count to 424, including 10 joint infections.  Of those, 31 patients died.

The same day, the Massachusetts pharmacy board director was fired.

Nov. 14: A congressional hearing on the outbreak is set to take place.  "The [New England Compounding Center] has a history of problems, some of which were documented in an FDA warning letter in 2006," the House subcommittee on Oversight and Investigation said in a statement announcing the hearing.  "We want to know what went wrong at this facility, the views and actions of its regulators, and that steps can be taken to ensure such an outbreak never happens again."

Copyright 2012 ABC News Radio

Wednesday
Nov072012

Fungal Meningitis Risk Period Over But Threat Remains

Hemera/Thinkstock(NEW YORK) -- The 42-day risk period for contracting fungal meningitis from tainted steroid injections ended on Wednesday, since the drugs were recalled on Sept. 26.  But new case reports will probably continue to trickle into the Centers for Disease Control and Prevention for at least a few months, said Dr. Tom Chiller, a fungal disease expert at the CDC.

With 18 new cases reported last Friday, and abscesses causing even fungal meningitis survivors to go back to the hospital with new symptoms, sighs of relief could be premature.

"Forty-two days is not a magic number by any sense of the word," said Chiller, who is the deputy chief of the CDC's Mycotic Diseases Branch.  "This is a moving target.  The outbreak is evolving."

The CDC publicized the 42-day period as a way for individual physicians to determine whether putting all at-risk patients on anti-fungal medications was a good idea, Chiller said.  Since anti-fungal medicine can cause liver and kidney damage, there was a risk it could do more harm than good.  The long risk period would mean a long anti-fungal regimen.

A CDC analysis revealed that while preemptive anti-fungal prescriptions reduced patients' risk of death or stroke from meningitis by .1 percent, they increased the risk of other adverse health problems by up to 14 percent, Chiller said.

Chiller said this kind of fungus, exserohilum rostratum, can have a very long incubation period.  Although the median incubation period so far has been 20 days, the longest incubation period went beyond 100 days, he said.

"One of the important things to add is that we do feel pretty confident that the further out you are from injection, the lower the risk," Chiller said.  "When that risk becomes zero, we don't know."

So far, 409 fungal meningitis cases, including 30 deaths, have been reported to the CDC this fall.  In addition, 10 people who received the shots to other parts of their bodies came down with fungal joint infections.  

Fungal meningitis, a deadly disease that causes inflammation of the membrane surrounding the brain and spinal column, is not spread from person to person.

Up to 14,000 people received the tainted injections produced at New England Compounding Center in Framingham, Mass, which recalled all products and shut down on Oct. 6.  It is now being investigated by the Food and Drug Administration, even though its oversight usually falls under its state's pharmacy board's jurisdiction.

It's not clear how the fungus got in the steroid vials, but an FDA investigation revealed that a quarter of the steroid vials in an NECC bin contained "greenish black foreign matter," according to an FDA form released Oct. 26.  The form went on to identify several clean rooms -- where sterile products are produced -- that had either mold or bacterial overgrowths.

Copyright 2012 ABC News Radio

Monday
Oct222012

Fungal Meningitis Outbreak: Death Toll Climbs to 23

Hemera/Thinkstock(WASHINGTON) -- Two more people have died from fungal meningitis linked to tainted steroid injections, raising the death toll for the outbreak to 23.

Over the weekend, the U.S. Centers for Disease Control and Prevention increased the tally of cases to 297 -- 294 cases of fungal meningitis and three cases of joint infections. The growing outbreak, which spans 16 states, has been linked to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain.

Sealed vials of the steroid, made by the New England Compounding Center in Framingham, Mass., contained Exserohilum rostratum, a fungus found in soil and plants.  It's unclear how the fungus landed in the sealed vials.

The CDC has confirmed 26 cases of Exserohilum meningitis, as well as one case each of Aspergillus and Cladosporium meningitis.

The New England Compounding Center has recalled all its products and shut down operations.  Calls to the owners were not immediately returned.

As many as 14,000 patients are thought to have received injections of the suspect steroid.

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients.  The "potentially contaminated injections were given starting May 21, 2012," according to the CDC.

Meningitis affects the membranous lining of the brain and spinal cord.  Early symptoms of fungal meningitis -- including headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, and redness or swelling at the injection site -- can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC's Dr. Benjamin Park.

"But we want to emphasize that we don't know what the longest will be," he added, stressing that patients who received injections of the recalled drug should stay attuned to the subtle symptoms "for months."

Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease.  Once detected, it can be treated with high doses of intravenous antifungal medications.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio

Wednesday
Oct172012

Fungal Meningitis Outbreak Claims Four More Lives; 245 Cases Reported

iStockphoto/Thinkstock(ATLANTA) -- The national meningitis outbreak continues to spread as health officials say the infection has killed four more people in Tennessee, Florida and Virginia.

The Centers for Disease Control and Prevention are now reporting 19 people dead and 245 cases of infection from fungal meningitis tied to contaminated back pain steroid injections.

[See a map of cases by state]

The government is asking doctors to tell patients if they received the medication from the New England Compounding Center.

Copyright 2012 ABC News Radio

Tuesday
Oct162012

Meningitis Scare: Spinal Tap Headaches Can Seem Like Infection

Stockbyte/Thinkstock(NEW YORK) -- Jim McGuire said he was relieved when doctors told him his spinal tap tested negative for fungal meningitis last week, but his feeling of panic returned the next day when a severe headache set in.

Although the headache could have been a result of his spinal tap, McGuire's doctor told him there was a chance he was experiencing the onset of meningitis -- even though he had tested negative the day before.

"It felt like there was a knife sticking in your head," McGuire, 51, said.  "I've had sinus headaches, which are more of a dull ache.  This was a very sharp pain that was constant."

And McGuire is not alone in wondering whether he is having a spinal headache or meningitis.  A spinal tap is the only way to tell if a patient has meningitis, and 40 percent of spinal tap patients get spinal headaches as a result, according to the Mayo Clinic.

More than 14,000 patients nationwide may have been exposed to fungal meningitis if they received contaminated compounded steroid injections manufactured by New England Compounding Co. in Massachusetts.  Of the 212 people who were infected, 15 have died, the Centers for Disease Control and Prevention said on Monday.  Another two patients developed joint infections.

McGuire spent eight hours in the hospital last Monday after he learned that he received a contaminated epidural injection for his back pain in August.  He was among about 300 patients to receive a spinal tap at Saint Thomas Hospital in Nashville, Tenn., because of the fungal meningitis outbreak, said hospital spokeswoman Rebecca Climer.

He then had to miss two and a half days of work, lying down at home with the drapes closed because his head hurt, he said.

If McGuire had a spinal headache, it would mean that spinal fluid leaked from the puncture where doctors performed his spinal tap, offsetting the normal pressure from fluid in the spinal column, said Dr. Joshua Bederson, who chairs neurosurgery at Mount Sinai Hospital in New York.

The brain produces and absorbs four cups of spinal fluid each day, he said.  When there's too little fluid, as in a spinal headache, the brain sags in the skull, pulling on veins that connect the outer surface of the brain to the inner surface of the skull.  That's what causes the intense headache.  It usually clears up on its own without major health complications.

Meningitis headaches, on the other hand, are caused by inflammation of the membranes in the brain and spine.  They can result in permanent neurological damage and death.

But which is which?

If the headache is positional, it's probably a spinal headache, Bederson said.  The patient should get relief from lying down, but feel more pain when he or she stands up.

If the pain is constant and not positional, it may be something else.

Copyright 2012 ABC News Radio

Sunday
Oct142012

CDC Reports 15th Meningitis Death

*UPDATE: The CDC confirms that the number of fungal meningitis cases linked to contaminated steroid injections has risen to 205. 

(NEW YORK) -- One more person has died from fungal meningitis linked to tainted steroid injections, raising the death toll for the outbreak to 15.

The U.S. Centers for Disease Control and Prevention reported Saturday that 198 people in 13 states have contracted fungal meningitis after receiving spinal injections of methylprednisolone acetate for back pain. One person has contracted a joint infection after receiving an injection for ankle pain.

As many as 14,000 people may have been exposed to the suspect steroid, made by the New England Compounding Center in Framingham, Mass. Fifty sealed vials of the drug, obtained by the Food and Drug Administration, were found to contain fungus. The firm has recalled all of its products and shut down operations.

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the CDC.

Fifty-two of the fungal meningitis cases -- six of them lethal -- have been reported in Tennessee. Cases have also been reported in Michigan, Virginia, Indiana, Maryland, Florida, Minnesota, North Carolina, Ohio, New Jersey, Idaho, Texas and, most recently, Illlinois.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC's Dr. Benjamin Park.

"But we want to emphasize that we don't know what the longest will be," he said, adding that patients who received injections of the recalled drug should be wary of the subtle symptoms "for months."

Fungal meningitis is diagnosed through a lumbar puncture, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

People affected by the current outbreak are being treated with two different types of antifungal medications until the type of fungus causing the infection -- aspergillus or exserohilum -- can be identified.

"These drugs are very strong and can be very difficult for patients to tolerate over time," said Dr. J. Todd Weber, incident manager of the Multistate Meningitis Outbreak at the CDC, adding that the agency is working with experts on the dose and duration of the treatments.

The CDC has confirmed one case of aspergillus meningitis and 10 cases of exserohilum meningitis. It's unclear how the fungi landed in the steroid vials.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio

Thursday
Oct112012

Fungal Meningitis Outbreak: 170 Cases, 14 Deaths

Hemera/Thinkstock(ATLANTA) -- The U.S. Centers for Disease Control and Prevention reported two more deaths linked to the outbreak of fungal meningitis from steroid shots for back pain, bringing the total number of people who have died to 14.

The CDC also reported that 170 cases of the rare form of fungal meningitis have now been reported in 11 states.

The outbreak of aspergillus meningitis has been linked to an injectable steroid, called methylprednisolone acetate, made by the New England Compounding Center in Framingham, Mass. A sealed vial of the drug, obtained by the U.S. Food and Drug Administration, contained levels of fungus that were visible to the naked eye.

The New England Compounding Center has recalled all of its products and shut down operations, but health officials estimate that 13,000 people may have been exposed to the suspect steroid since May.

Forty-nine of the fungal meningitis cases -- six of them lethal -- have been reported in Tennessee. Cases have also been reported in Florida, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Virginia and, most recently, Idaho.

[For a map of cases by state, click here.]

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the U.S. Centers for Disease Control and Prevention.

For a full list of clinics receiving the recalled lots of spinal steroid injections, click here.

"If patients are concerned, they should contact their physician to find out if they received a medicine from one of these lots," said CDC's Dr. Benjamin Park, adding that most of the cases occurred in older adults who were healthy aside from back pain.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take nearly a month to appear. Left untreated, the inflammatory disease can cause permanent neurological damage and death.

"Fungal meningitis in general is rare. But aspergillus meningitis -- the kind we're talking about here -- is super rare and very serious," said Dr. William Schaffner, president of the National Foundation for Infectious Diseases and chairman of preventive medicine at Vanderbilt University Medical Center in Nashville. "There's no such thing as mild aspergillus meningitis."

Fungal meningitis is diagnosed through a lumbar puncture, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

"Treatment could be prolonged, possibly on the order of months," said Park, adding that the IV treatment would require a hospital stay.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio







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