The potential scope of the meningitis outbreak that has killed at least five people widened dramatically Thursday as health officials warned that hundreds, perhaps thousands, of patients who got steroid back injections in 23 states could be at risk.
Clinics and medical centers rushed to contact patients who may have received the apparently fungus-contaminated shots. And the Food and Drug Administration urged doctors not to use any products at all from the Massachusetts pharmacy that supplied the suspect steroid solution.
It is not clear how many patients received tainted injections, or even whether everyone who got one will get sick.
So far, 35 people in six states — Tennessee, Virginia, Maryland, Florida, North Carolina and Indiana — have contracted fungal meningitis, and five of them have died, according to the Centers for Disease Control and Prevention. All had received steroid shots for back pain, a highly common treatment.
In an alarming indication the outbreak could get a lot bigger, Massachusetts health officials said the pharmacy involved, the New England Compounding Center of Framingham, Mass., has recalled three lots consisting of a total of 17,676 single-dose vials of the steroid, preservative-free methylprednisolone acetate.
Outbreak points to pharmacy problem
An unknown number of those vials reached 75 clinics and other facilities in 23 states between July and September, federal health officials said. Several hundred of the vials, maybe more, have been returned unused, one Massachusetts official said.
But many other vials were used. At one clinic in Evansville, Ind., more than 500 patients got shots from the suspect lots, officials said. At two clinics in Tennessee, more than 900 patients — perhaps many more — did.
The investigation began about two weeks ago after a case was diagnosed in Tennessee. The time from infection to onset of symptoms is anywhere from a few days to a month, so the number of people stricken could rise.
Investigators this week found contamination in a sealed vial of the steroid at the New England company, according to FDA officials. Tests are under way to determine if it is the same fungus blamed in the outbreak.
The company has shut down operations and said it is working with regulators to identify the source of the infection.
"Out of an abundance of caution, we advise all health care practitioners not to use any product" from the company, said Ilisa Bernstein, director of compliance for the FDA's Center for Drug Evaluation and Research.
Tennessee has by far the most cases with 25, including three deaths. Deaths have also been reported in Virginia and Maryland.
Meningitis is an inflammation of the lining of the brain and spinal cord. Symptoms include severe headache, nausea, dizziness and fever.
The type of fungal meningitis involved is not contagious like the more common forms. It is caused by a fungus often found in leaf mold and is treated with high-dose antifungal medications, usually given intravenously in a hospital. The common mold aspergillus was cultured from 5 patients, the CDC said Thursday.
Robert Cherry, 71, a patient who received a steroid shot at a clinic in Berlin, Md., about a month ago, went back Thursday morning after hearing it had received some of the tainted medicine.
"So far, I haven't had any symptoms ... but I just wanted to double check with them," Cherry said. "They told me to check my temperature and if I have any symptoms, I should report straight to the emergency room, and that's what I'll do."
The New England company is what is known as a compounding pharmacy. These pharmacies custom-mix solutions, creams and other medications in doses or in forms that generally aren't commercially available.
Other compounding pharmacies have been blamed in recent years for serious and sometimes deadly outbreaks caused by contaminated medicines.
Two people were blinded in Washington, D.C., in 2005. Three died in Virginia in 2006 and three more in Oregon the following year. Twenty-one polo horses died in Florida in 2009. Earlier this year, 33 people in seven states developed fungal eye infections.
Compounding pharmacies are not regulated as closely as drug manufacturers, and their products are not subject to FDA approval.
A national shortage of many drugs has forced doctors to seek custom-made alternatives from compounding pharmacies.
The New England company at the center of the outbreak makes dozens of other medical products, state officials said. But neither the company nor health officials would identify them.
The company said in a statement Thursday that despite the FDA warning, "there is no indication of any potential issues with other products." It called the deaths and illnesses tragic and added: "The thoughts and prayers of everyone employed by NECC are with those who have been affected."
A 2011 state inspection of the Framingham facility gave the business a clean bill of health.
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I just had an injection last Friday and have been feeling sick to my stomach and have had jaw pain since then. I called my clinic here in MN to see if it was possible that I could have gotten an infected injection. They gave me a phone number that goes straight to a message that says "sorry we are having system problems at this time" and then hangs up - WTF?!?!?
Don't believe that nausea and jaw pain are symptoms of meningitis,by last Fri.-anyplace that had this med. shipped to it had been notified.
You could be worried for nothing-by all means-check with your Dr.,but from what you posted-you may bhe overreacting.
I get injections every 6 weeks and just called my orthopaedic physician and they assured me the injections I get are safe. Evidentally, it is only affecting pain clinics not private practices but this is certainly a scary thing.
17,000 + multiple dose Vials? THAT IS NOT A COMPOUNDING PHARMACY! That is a manufacturer!
We made this product in the late 80's and were subject to routine FDA CGMP inspections. We made about 60,000 units a year and sold them to distributors who in turn sold the product to Physicians and hospitals. Cost of manufacture was about $1.75 a unit and we sold it for $2.75. Wholesalers doubled up on that. My company NEVER had a problem complying with Federal and State Regs.
In fact I still have access to the Master Formula Cards and detailed compounding and manufacturing instructions.
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 vials 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.
Given the current regulatory structure,, more of this crap is going to happen since the FDA does not have the man power to police these shoddy operations. State pharmacy boards are inept since they have no idea of what a MANUFACTURING PHARMACEUTICAL CHEMIST does.
The press is even more inept in the coverage of this story!
It will be interesting to see how this all plays out
My private practice got some of the "bad lots", so I would say that as a general statement, no setting is out of the question initially, e.g., doctor's office, pain clinic or hospital. On the other hand, our local hospital does not purchase from New England Compounding, so they are OK. We have used New England Compounding, one of the biggest compounding pharmacies in the country for probably 20 years plus and this is the first problem I am aware of, not that that excuses them.
If you have had an injection with this drug at any body site, not just an epidural, and you start to feel bad, run a temp, etc., go immediately to the nearest ER and explain the situation to them. Don't wait until tomorrow. This is particularly true if you have health issues, e.g., diabetes, are immunocompromised for some reason, etc..
My wife has been having some of these types of injections. Yesterday her clinic called her to come in for an antifungal injection and last nite she had to go to the hospital pharmacy to pick up some antifungal meds. I knew immediately what was going on. Of course we had to pay for the meds.
This morning she got 4 calls from attorneys looking for clients. Don't know how they knew. The sharks are circling.
I have been getting cervical epidural injuections and trigger point injections from one of the clinics listed on the CDC's list. I have not heard anything from them and figure I have to wait til Mon or Tues (holiday). I suffer from many illnesses including diabetes, epilepsy, possible Fibromylagia, etc. I have been having headaches not typical for my migraines (they always respond to Ibuprofen and these do not), dizziness, and some nausea for a few weeks now. I have so many medical issues and medications it is hard to know where things are coming from. I don't want to be a hypochondriac and over-react. I have taken my temp and do not have one. I will keep checking it (it may not be accurate as I take Vicodin for pain and Tylenol is in it, which is an anit-pyrectic) and call Monday. I would assume that if I got an infected batch they would have called me.?!
Trigger point injections are worthless in 90% of cases,they only give any substantial pain relief for 12-24 hours.
I learned that from my Dr. actually,all it does is get the Dr. and/or the practice/clinic a way to bill insurance and make a nice profit.
Ask your Dr. to explain exactly how trigger point injections work,then ask how long whatever you are being injected with relieves pain- if you have an honest Dr. he or she will tell you that trigger point injections offer a very short time span of pain relief.
Your true body temp. is going to be hard to get,as the vicodin raises your body temp while the acetaminophen in it lowers body temp,plus any other meds you take could alter your body temp.-
Talk to your Dr. to find out what you should do to check for symptoms.