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Subscribe to RSSHealth officials are working to track down everyone who may have been treated with an injection for lower back pain that is linked to an outbreak of rare fungal meningitis. So far, 35 people have been diagnosed with the infection in six states and five of them have died.
At least 75 clinics in 23 states received batches of the steroid drug from a Massachusetts compounding pharmacy and have been told to notify all affected patients, health officials said.
"Unfortunately, despite the current recall, we expect to see additional cases as this investigation unfolds. However, it is possible if patients are identified soon and started on appropriate antifungal therapy some of the unfortunate consequences may be averted," Dr. Benjamin Park of the U.S. Centers for Disease Control and Prevention told reporters in a telephone briefing.
Food and Drug Administration officials warned health care workers not to use any drugs from the New England Compounding Center in Framingham, Mass., which has voluntarily ceased distribution of all of its products.
The 35 cases include 25 people in Tennessee, one in North Carolina, two in Florida, three in Virginia, two in Maryland, and in Indiana, the CDC reported. Three of the deaths were in Tennessee, one in Virginia and one in Maryland.
"Infected patients have presented approximately one to four weeks following their injection with a variety of symptoms including fever, new or worsening headache, nausea and our new symptoms consistent with a stroke," Park said. "Some of these patients symptoms were very mild in nature. Cerebrospinal fluid obtained from these patients has shown findings consistent with meningitis. It is important to note that this type of meningitis is not transmissible from person-to-person."
Health officials are asking anyone who had a spinal injection for pain and who has symptoms such as a headache, stiff neck, dizziness or trouble walking to see a doctor right away.
The drug is question is called methylprednisone and is used mostly to treat older patients for lower back pain. Tennessee officials were the first to notice the unusual cases of meningitis, and discovered that the patients involved had all been treated at three specialty clinics. All had recieved direct injections of the steroid into their spines for pain. Women who received epidural infusions for childbirth are not in danger, the officials said.
Health officials have isolated aspergillus from five patients, CDC officials said. In addition, FDA officials detected fungal contamination in an unopened vial of methylprednisolone from one of three lots of 80-milligram injection doses recalled by the New England Compounding Center.
"Looking under microscopic examination, it was identified as a fungal contaminant. For the sake of time, because we -- everything is unraveling and unfolding very quickly, we have not been able to further microbial testing of additional vials and what is necessary. So, right now, we can only say that it is a foreign material," FDA's Dr. Ilisa Bernstein said.
Everything the pharmacy made is being checked. Berstein said it's not clear how many potentially contaminated vials of steroid were distributed. "But if they are licensed in 50 states, there is a possibility that it could be elsewhere, not just this product, but as well as other products that they have made," she said.
Meningitis is an inflammation of the spinal cord, usually caused by bacteria or viruses. It can be very serious and is marked by a 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.
Aspergillus is tricky to treat. It’s an infection that patients with damaged immune systems can get – notably cancer patients and those with HIV infection. It’s often found in the lungs because the mold – found in dead leaves and elsewhere -- can be breathed in. An antifungal drug called voriconazole can treat the infection but the health officials said in this case they want to be sure before they try it. The side effects from the antifungal treatment can be severe and include kidney and liver damage.
"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.
Health officials are now trying to track down people in 23 states who got epidural steroid injections. NBC's Robert Bazell reports.
Related links:
- Outbreak points to pharmacy problems
- Parents of killed toddler settle tainted wipes lawsuit
- Calif. lab worker died after handling rare meningitis strain
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Even more tragically, there is considerable evidence that this treatment is essentially a placebo. The two largest, highest-quality clinical trials of methylprednisolone versus placebo injections found no or almost no benefit. Most studies that tested the addition of methylprednisolone to an analgesic also found that it added no further benefit. You can find the abstracts for these studies on PubMed by searching for "methylprednisolone chronic back pain." You can also learn there that even without the Aspergillus, this inherently risky drug has been reported to cause side effects including pneumonia, myopathy, abscesses, and sudden permanent paraplegia. A placebo that can cripple or kill you is a really lousy placebo. Perhaps this is why it is being prepared by a compounding pharmacy, because there are not enough mainstream physicians using it to support regular factory production. But I do hope that the allopaths in these sad cases provided informed consent to their patients regarding the known side effects and the evidence that real benefit is likely to be minimal; if not, well, I'm sure their attorneys will find that fact very interesting.
This product is a suspension and very tricky to manufacture. That said, "Compounding Pharmacies" Should not be permitted to manufacturer sterile parenteral drugs unless they have the following in place:
1. Approved Master Formulas with complete work instructions.
2. Segregated compounding areas in full compliance with FDA CGMP's
3. Class 10,000 sterile rooms with laminar flow hoods.
4. DI WFI used for washing and processing vials and stoppers.
5. Ovens to vails heat to temps of over 500 degrees f for 8 hours to burn off pyrogens.
6. In process sterility testing.
7. In process assays
8. Final container sterility testing
9. Final container assays
10. Stability testing.
11. Full VALIDATION protocols for all of the above.
Thanks to the Republicans and their free market approach, more of this crap is going to happen since the FDA does not have the man power to police these quack operations.
jane,
admittedly not a topic I know a lot about offhand, but my search turned up this article:
http://www.ncbi.nlm.nih.gov/pubmed/21897343
and its 2 yr f/u
http://www.ncbi.nlm.nih.gov/pubmed/22828681
and this article:
http://www.ncbi.nlm.nih.gov/pubmed/22828691
all of which dispute your conclusion (although not by much, again, admittedly)
Because of the republicans???!! You are insane!! The health care and big pharma industries are the most federally regulated industries in the nation! Regulations are supposed to stop this kinda stuff according to people like you, but you know what just took 1st place on the leading cause of accidental death above automobile accidents? Prescription drug abuse. The fact of the matter is that big government doesn't work, never has. The ONLY thing that works is personal responsibility and thanks to LIBERALS and people such as YOU, there is no more personal responsibility. Its all a numbers game of acceptable losses, now. No criminal charges will be filed against anyone in these cases of wrongful death. People and entities will be sued and insurance companies will pay...raising the cost of all our insurances that much more. Try to think a little deeper than you neanderthalic ..."me hungry...need food.." way of thinking for a change.
Eric - If someone does the search I suggested, they will find a few studies that show modest benefit, but more and larger studies that show none. The first study you link to above suggests that there is little difference between a plain lidocaine injection and lidocaine plus steroid; there's no steroid-only group and no placebo group. The third link, to a meta-analysis, does suggest that there is some benefit for certain specific types of back pain, but not for others. (I do wonder how accurately these types are classified, e.g., how do we know who has "discogenic pain," given that pain is routinely attributed to disc abnormalities seen on x-ray even though many other people have the same abnormalities with no pain?)
For me, the evidence in favor of this procedure doesn't look strong enough for any type of chronic back pain that I'd subject myself to such a procedure unless I was really, truly in agony. But the question is whether patients who are comparable to the patients in the large negative studies were told about those studies by their doctors, or whether they were just told that "this would help." Patients should not have to go to PubMed in order to receive honest information.
I did do the search, and the studies that came up were the ones I posted. If you have negative studies, I suggest you post them.
Either way, though, the studies I posted are fairly robust. It appears that the question is more open than your post implied
Little difference, as I acknowledged, but still a difference
Jane, i want you to think about this for just a second--its really hard to do a placebo with epidural injections. sure, you can do a "sham procedure" but thats pretty hard to get past an IRB with something invasive like this
agreed, so again, not as clear cut as you made it sound
no way to know for sure. Its fairly telling of your bias that you always seem to imply docs in the most negative light though....
Im sure you'll claim Im biased in the opposite direction, which may be true, but I don't make blantantly biased comments like you last sentence that are supported with no evidence whatsoever.
Well if the manufacturer would have listed those side effects on their packages, like the big pharma 'smarties' on T.V. do in their ads, I guess they would have no problems now!
fgh,
"Well if the manufacturer would have listed those side effects on their packages"
Do you mean side effects like "May cause sudden death"? They rarely list that one even though it is more common than most people realize. It's calculated to reduce sales, and that simply will not do.
I have to agree with mickey here. "May contain a life threatening fungus" is not normally considered a side effect.
Hmm. I am wondering - my cat had a back issue 2 weeks ago. He was fine, eating well and all of his systems were perfect. The vet told me he would gave him an injection of Prednisone and see how he did. Cody, unexplainably, died 4 hours later. Does anyone know if Methylprednisolone is used in veterinary cases?
Evidently yes. Do a web search on "Methylprednisolone injection used by Vets on cats?"
Okay Righties, those that hate the government. Here are the simple facts: One, a government agency caught this and stopped further release. Second, the company that distibruted the drug, if fined, will not act like "people that are corporations." If there's any penalty, it will come from the corporation which is not people. If "corporations are people, then "people" in the corporation should pay the fines out of their own salaries and be prosecuted as "people."
John Colorado,
"If "corporations are people, then "people" in the corporation should pay the fines out of their own salaries and be prosecuted as "people.""
I agree. But if corporations are not people, you can be sure they will act like people in passing on the cost of being sued to the consumer in the form of higher drug prices.
The misinformation being thrown around here is scary. Yes, steroids, particularly when used chronically, have a lot of side effects. For the acute uses such as back pain, the drugs are extremely safe. Of course, the package insert will scare you to death. But so will a list of all of the side effects caused by aspirin or acetaminophen. The issue here is that for some reason the physicians are using a compounding pharmacy for their source. For this drug, this is unnecessary and increases the potential for problems, as steroids are widely available from manufacturers. The fact that the product is contaminated with Aspergillus means that the sterile process at the pharmacy has problems. While these problems are rare with these pharmacies, the chances are certainly greater than with a manufacturer, where the processes are much more rigorous.
Brief use of an oral steroid is usually safe. The side effects of having it injected into your spine can include paraplegia. That may be a rare outcome, but still, this is not comparable to taking an aspirin. Since this procedure appears to have little or no real benefit for chronic back pain, the expected ratio of costs and risks to benefits is high enough that most back pain patients would probably refuse it if they received unbiased information. Steroid injections are made by regular manufacturers, but it seems that there is a shortage of this product, as there have been shortages of many pharma products in the past couple of years, that makes more business for compounding pharmacies.
IMO, epidurals for pain are a misguided procedure, now that I have found the exact reason why they do not work. Janet G. Travell, MD protocols for complex pain issues do NOT mention this procedure at all. I would even bar it from being done for chronic myofascial pain issues.
My guess is that it will spread. Meningitis is extremely contagious.
Edit:
Oh wait they said fungal. Never mind. Viral meningitis is super contagious but fungal is not. On the other side here we have another corporate originating disease being spread around. We need tighter FDA regulatios and apparently tighter regs for drug manufactures.
They probably outsourced the drug to China and then repackaged it to save money. Did they test for engine coolant?
Don't look to the FDA for help. They are too busy being puppets of the administration and drug companies.
They did not prove the culprit was the injections. Many people I know in the past few weeks have suffered from symptoms such as these. My family of 5, including myself, had what we thought to be the flu. Severe headache, fever, body aches, sore throat, bad cough, neck pain and severe back pain. Most meningitis cases aren't life threatening. Those who are immuno-compromised, the eldery, the young and the sick are most at risk for not being able to recover. What if there just happens to be a meningitis out break? Why is the medical/media community so narrow minded with illness and where it comes from. Reminds me of a few years ago when a bad "cough" was going around and then mysteriously weeks/months later it was in the news that immunity to whooping cough in certain age groups had expired and they had to be re-inocculated. It was never reported that that bad "cough" was actually whooping cough. If you think we as the public are accurately and truthfully informed about everything, then you, are sadly, the fool.
You are incorrect on several levels. First, they have pinpointed the cause and source of the infections and have stopped both production and administration. Secondly, A "meningitis" is an infection of the brain or the brain stem and is ALWAYS serious and life threatening. The bacteria responsible for causing most incidents of BACTERIAL meningitis are common and do not normally cause disease or complications in otherwise healthy individuals. A fungal Meningitis is very serious for several reasons. First, it is rare because seldom does a fungus invade the spinal cord, brain, or brain stem and treatments are not as numbered, common or successful.
My question to all of you is this. My wife recieved an injection of this type on Sep 25, and we are unsure of the origin of the compound. Yesterday, she began experiencing stiffness in her neck and shoulders, but no other apparent symtoms. What should we be doing?
You should be getting her to the hospital immediately. A different hospital that has nothing to try and protect except her life.