meningitis

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The First Meningitis Patient, And The Medical Mystery Of The Black Mold

Exserohilum rostratum

Exserohilum rostratum (Wikimedia Commons)

 

The medical detective story of how Vanderbilt doctors figured out the link between tainted steroid injections and life-threatening meningitis came out almost three weeks ago — but now you can read the full (and frightening) clinical details of that “index case” in The New England Journal of Medicine here. 

The authoritative account includes the disturbing details of a man in his fifties who suddenly went into rapid decline a month after he had a spinal steroid injection. He comes in with “nausea, malaise, fatigue, chills, and decreased appetite.” Despite antibiotics, his pain worsens and he becomes “agitated, with incomprehensible speech.” He’s treated with more drugs, but by his sixth day in the hospital, he’s having “intermittent staring spells, and a transient right facial droop.” The next day, the lab identifies the fungus Aspergillus and he is treated for it, but to little avail.

On hospital day 11, the patient abruptly became unresponsive, with rhythmic shaking of the head that was consistent with seizure activity. He was intubated and mechanical ventilation was initiated. A head CT scan showed intraventricular hemorrhage involving the lateral ventricles, subarachnoid hemorrhage in the perimesencephalic cistern, and worsening hydrocephalus.

The man died on his 22nd day in the hospital.

‘It remains a mystery as to why the index case is the sole case in which A. fumigatus was detected.’

The New England Journal also features an informative update on the meningitis outbreak, which points up an oddity of the findings thus far: That first, index case reported finding Aspergillus fumigatus in the patient, but that fungus “has not been detected in any of the subsequent 200-plus cases. The major culprit appears to be Exserohilum rostratum, a plant pathogen that rarely causes human disease. This mold has been cultured or identified by means of a polymerase-chain-reaction (PCR) assay from cerebrospinal fluid in at least 25 patients and has been detected in at least one unopened vial from the implicated lot of methylprednisolone.”

The theory that E. Rostratum, a black mold, is the villain here fits with past cases: Continue reading

Hospitals Worry Meningitis Fallout May Worsen Drug Shortages

(multimediaimpre/flickr)

Hospitals across the state are worried that the temporary closure of a pharmaceutical manufacturer in Westborough may increase the chronic problem of drug shortages.

Ameridose is a key supplier of IV antibiotics and prefilled syringes. There are no reported problems with Ameridose products, but the company stopped operations while an investigation of contaminated steroids at a jointly owned pharmacy, New England Compounding Center, is under way.

The Massachusetts Hospital Association says the effects of the Ameridose shutdown vary widely, depending on a hospital’s reliance on the company. At Massachusetts General Hospital, Dr. Elizabeth Mort says the hospital is looking for new suppliers:

“If, however, Ameridose is closed for a prolonged period of time, it will be all the more challenging to keep the drug supply uninterrupted to our patients.”

The state has agreed to help hospitals manage and replenish shortages that arise while Ameridose is closed.

Meningitis Outbreak: Latest CDC Info, What Doctors And Patients Should Do

(CDC)

The CDC has just sent over this digital press kit on the fungal meningitis outbreak, but why should it be only for the press? Just this weekend, I heard about a Boston-area man who’d had one of the steroid injections implicated in the outbreak and was now vomiting; then word arrived that the first New England cases had been reported, in New Hampshire. The fungus can apparently incubate for weeks; it will be quite a while before patients who got the injections can rest easy.

So for anyone out there who’s concerned, the CDC offers a cornucopia of official resources, including the numbers of the contaminated lots and guidance for both patients and doctors. A couple of updates: The CDC posted a bulletin yesterday that it is not recommending any preventive treatment for patients who were exposed but are showing no symptoms. And here, also from yesterday, is “What should physicians be doing?” In brief, they should check if they used any of the contaminated lots, contact patients who’d been exposed, and, if they have symptoms, refer them for diagnostic procedures.

They’ll be posting updates and so will we, but for now, the basics are here:

Patients who believe they might have received a potentially contaminated medication should contact the physician who performed their procedure to find out if their medication was from one of the three lots.

Patients who received a potentially contaminated medication should seek medical attention if they have any symptoms. Continue reading

Meningitis Roundup: AG Involved; Assigning Blame; First Suit Filed; Brown Donations

aspergillus

The fungus Aspergillus niger shows up as a black mold on decaying vegetation and food. (CDC via NPR)

This morning’s reporting on the national meningitis outbreak from the WBUR news team:

• The state attorney general’s office says it is cooperating with state and federal investigations into the Framingham company tied to a deadly national outbreak of meningitis — and that criminal and civil charges could be brought once it determines how the pharmacy distributed the drugs suspected to be tainted.

• Meantime, regulators and the Framingham company linked to the outbreak are deflecting responsibility. WBUR’s Martha Bebinger has the story:

WBUR’s Martha Bebinger

New England compounding center was licensed to fill individual prescriptions but was shipping medications in bulk. Federal regulators say they didn’t have the authority to crack down on a pharmacy. And Massachusetts regulator Madeline Biondolillo says the company, NECC, misled the state: Continue reading

Probe Of Pharmacy Linked To Tainted Steroids Widens; 14 Now Reported Dead

(multimediaimpre/flickr)

As of today, 14 people have died in a national meningitis outbreak linked to a Framingham compounding pharmacy.

WBUR’s Martha Bebinger reports:

Federal officials say as many as 14,000 people may have been exposed to tainted medication from the New England Compounding Center.

State and federal regulators say they are still investigating the exact cause of the outbreak. But the FDA’s Deborah Autor says regulators would like more clarity about state and federal authority over such pharmacies.

State regulators say it appears that the New England Compounding Center violated state law by supplying large amounts of medicines without an individual prescription.

Sources close to the investigation says NECC followed state laws.

The Massachusetts Department of Public Health says New England Compounding Center was licensed to mix specialized medications based on individual prescriptions. So selling vials of steriods in bulk to hospitals across the country, where 169 patients are now ill from tainted injections, was not allowed, says Madeleine Biondolillo, with the DPH. Continue reading

Meningitis Outbreak: 5 Dead, Recalled Steroids Shipped To 23 States

(CDC)

An official from the CDC suggested today that any “concerned” patient who has had steroid injections for back pain since July might want to contact their doctor to make sure the drugs used were not part of a recalled batch.

Three batches of the steroid, Methylprednisolone Acetate (now recalled) have been linked to an outbreak of rare fungal meningitis. As of Thursday, officials say that 35 cases in 6 states, including five deaths, have been reported.

Moreover they said in a conference call with reporters today, that 23 states, including New York, New Jersey, Rhode Island, Connecticut and New Hampshire, have received the steroid that was recalled.

As previously reported, a compounding pharmacy in Framingham, the New England Compounding Center, is at the center of the investigation. AP reported earlier today that the NECC has voluntarily suspended operations:

In a statement Wednesday, the New England Compounding Center said it was working closely with the Massachusetts Department of Public Health and other regulators to identify the source of infection.

The company said that immediately after it was notified about the infections it initiated a voluntary recall Sept. 26.

Continue reading

DPH On Meningitis Outbreak Linked To Framingham Pharmacy

(gliageek/flick)

This just in from the state Department of Public Health:

BOSTON – The Massachusetts Department of Public Health (DPH) today released a statement regarding the investigation of the national meningitis outbreak:

“The Massachusetts Department of Public Health is collaborating with the CDC, FDA, and other state public health officials to identify the cause of an outbreak of more than 25 suspected cases of aspergillus (fungal) meningitis under investigation in Florida, Maryland, North Carolina, Tennessee and Virginia. The cause for this cluster of cases is not yet known. There are four products common to all of these cases. One medication, Methylprednisolone Acetate, a steroid, was prepared at the New England Compounding Center, Inc (NECC), a pharmacy in Framingham, Massachusetts. It has been recalled and quarantined as a precaution. NECC is voluntarily recalling all similar medications. In addition, at the request of DPH, NECC has agreed to voluntarily surrender their license to operate until this investigation is complete. The form of fungal meningitis in these patients is not transmitted from person to person. There are no known cases in the Commonwealth.”

Here’s a statement emailed from the FDA:

FDA is working with CDC, several state health departments and the Massachusetts Board of Pharmacy on this issue and is still investigating the scope and cause of the outbreak of fungal meningitis.

What I can tell you is that on September 26, New England Compounding Center (NECC) conducted a voluntary recall of 3 lots of Methylprednisolone (PF) 80mg/ml Injection produced at NECC. The lot numbers of this product are:
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, Beyond Use Date (BUD) 11/17/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

Help For Paranoia: A Primer On Bacterial Meningitis

Autopsy slide of bacterial meningitis


Bacterial meningitis is extremely rare, and also extremely crazymaking: Many of its symptoms overlap with the sorts of seasonal viruses that sweep through the population in chilly weather, turning the nasty hassle of a bug into a source of mortal fear.

In the wake of the awful news that a Boston Latin Academy 7th-grader died of probable bacterial meningitis on Monday evening, many of us may be reinterpreting every headache and fever. So I’m deeply grateful to Sacha Pfeiffer and Lynn Jolicoeur of WBUR’s All Things Considered for this helpful primer on bacterial meningitis. They quote Dr. Paul Sax of Brigham and Women’s Hospital on the symptoms of possible bacterial meningitis:

“A person who has a very severe headache, very high fevers, a person who says it’s the worst headache of my life. A person who says that they have a very stiff neck in association with that fever and headache. Also, if there’s been any change in sort of the level of cognition of a child or an adult, someone who’s sort of not thinking right while those things are going on, those would also be very much warning signs. And also in particular, fever and headache and a rash would be particularly alarming.”

And his advice for parents: Continue reading

Daily Rounds: Don’t Blame Health Reform; Harvard’s Primary Care Boost; Food Labeling Highlighted; Health Care Abuse Tops List; Meningitis Booster For Teens

Health Law Hardly At Fault For Rising Premiums : NPR “Celinda Lake runs the Democratic polling firm Lake Research. She said her firm's premiums are going up 20 percent.
"My broker told me that it's because of health insurance reform," she says. But is it really? Absolutely not, says Jay Angoff, who heads the Office of Consumer Information and Insurance Oversight for the U.S. Department of Health and Human Services. "It would be inaccurate and silly to blame it on the new law," he says.” (npr.org)

Harvard looks to lift primary care – The Boston Globe “Harvard Medical School has received a $30 million anonymous gift to create a major center to transform primary care medicine, a specialty that provides routine front-line care to millions of people but that many doctors consider unglamorous and underpaid.” (Boston Globe)

Food Companies Plan Front Label With Nutritional Data – NYTimes.com “Responding to pressure from federal regulators, a major food manufacturers organization said Wednesday that it would develop a labeling system for the front of food packages that would highlight the nutritional content of foods, including things like calories, unhealthy fats and sodium that many consumers want to limit. The group, the Grocery Manufacturers Association, said the labeling system would be introduced early next year.” (The New York Times)

Top 10 Federal Fraud Settlements Had Health Twist : Shots – Health News Blog : NPR “The government recovered $2.7 billion in the top 10 cases during the fiscal year that ended Sept. 30, according to TAF. Even we, who also pay more than a little attention to these cases, were a little surprised that all the biggest settlements last year involved health care. Drugmaker Allergan led the settlement ranks last year, paying $600 million to settle claims it went too far in selling Botox.” (npr.org)

CDC panel: Teens need another meningitis shot – Boston.com “Teens should get a booster dose of the vaccine for bacterial meningitis because a single shot doesn't work as long as expected, a federal advisory panel said Wednesday.” (Boston Globe)