Meningitis outbreak may affect more than 23 states

The Centers for Disease and Control and Prevention (CDC) and Food and Drug Administration (FDA) announced today they are advising medical professionals not to use any products manufactured by the New England Compounding Center in Framingham, Mass., due to an outbreak of fungal meningitis tied to some medications made by the company.

Three lots of the company's preservative-free methylprednisolone acetate that go back to July 2012 have been recalled and are believed to be the cause of the recent outbreak. Thirty-five cases of fungal meningtitis in six states have been identified, with five deaths. The majority of the cases, 25 in total, have been discovered in Tennessee.

"Given the severity of illness, we believe these precautionary measures are warranted to protect public health," Ilisa Bernstein, director of the FDA office of compliance, said to reporters during a conference call today.

• Meningitis outbreak sickens 35 in 6 states, kills 5
• Tenn. meningitis outbreak tied to steroid shots

Dr. Benjamin Park, medical epidemiologist with the Centers for Disease Control and Prevention, told reporters that 23 states may have received shipments of the tainted product. These states include: 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. A total of 75 facilities may have received product from one of these three recalled lots.

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Deadly meningitis outbreak in U.S.

However, because the New England Compounding Center is licensed in all 50 states, there is a possibility contaminated products may be in other areas, Bernstein said.

"We don't know the scope of this," she admitted.

The initial three-lot recall by the New England Compounding Center involved 17,676 vials, the CBS News Investigative Team reported. There were two complaints filed against the company -- one in 2002, one in 2003 -- that were investigated and as a result the company entered into an agreement in 2006 with the Massachusetts Department of Health to correct any deficiencies. That same year, the FDA warned the company against compounding topical anesthetic creams for general distribution.

In March 2012, a complaint unrelated to the meningitis case was filed against the company regarding the potency of its eye medication. That complaint is still open and pending, according to the investigative team.

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Meningitis outbreak linked to Mass. pharmacy

Fungal meningitis is a non-contagious form of the disease. It is often caused by fungus normally found in leaf mold. Authorities said some people were experiencing mild stroke-like symptoms, including slurred speech, and difficulty walking and urinating. Other fungal meningitis symptoms include worsening and severe headache, nausea, dizziness and fever.

It can be treated with high-dose antifungal medications, usually given intravenously in a hospital. The earlier the disease is diagnosed and treated, the better the chances of survival are.

"We think that early antifungal treatment can improve the outcome of these patients," Park said.

Park said that the CDC was notified of a patient with an onset of meningitis 19 days after receiving an epidural steroid injection on Sept. 21 in Tennessee. Although all initial cultures were negative, fungus was isolated from the patient's cerebral spinal fluid. On Sep. 28, the CDC was notified of cases outside of Tennessee.

In total, one case in North Carolina, two cases in Florida, four cases in Virginia, two cases in Maryland and one case in Indiana have been discovered in addition to the 25 cases in Tennessee. Three people have died in Tennessee, as well as one person from Virginia and one person from Maryland.

The victims tend to be elderly because of the nature of patients who receive spinal epidural injections because of lower back pain. Overall, many of the patients were somewhat healthy until infection.

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Woman may have been exposed to meningitis

On Oct. 1, the New England Compounding Center voluntarily shut down their manufacturing center. During a FDA investigation of the plant, the investigators discovered contaminants in an unopened vial.

"Materials from an unopened vials was looked at under the microscope at an FDA lab and what was looked at under the microscope looked like a fungal matter," an FDA spokesperson confirmed.

The FDA added that they are working with the firm to get more information about their products. The investigation is ongoing.

[jacqui54]

I went to Dr. in Aug,my Dr gave me 5 shots in my back,I have been feeling so sick,I feel like I laid on the floor and everyone kicked me,my neck hurts so bad and headaches,but no fever and just a little nausea on and off....my Dr. is in N,J....I just herd about this from my sister she thinks I should call Dr. right away,I did today but got only answering machine,now i`m worried I might of picked this up.....I feel like I have a flu without the fever,i`ve been feeling like this for about a week or two,I just don`t understand why every bone,joint in my body hurts so much even my elbows,fingers,arms and shoulders.maybe it`s just a coincident(that`s not spelled right)if I don`t hear from Dr. tomorrow will call back to see what`s going on.

[oldngrouchy]

Where can I find a list of states that have received the tainted vials?

[Gen38]

Why is this listed as an "out break"? It is from a pharmasutical product that was injected. It is made out to be something contagious when it isn't .

[chyenna1]

Are hospitals and clinics buying medications from smaller pharma's bc cost is cheaper??? And if that is the case, curious to know are these savings passed on to patients or just diseases. This makes me leary to have my medications filled at very small pharmacies. If small pharma's sell to pharmacies bc price is cheaper, what other dangers may lie and wait.

[THALES457]

THIS IS ONLY A GUESS. NORMALLY VIAL FILLING IS DONE IN A CLASS 100/ISO 5 LAMINAR FLOW CLEANROOM. SUCH A ROOM IS VERY EXPENSIVE. SO, A LITTLE PHARMA MIGHT POSSIBLE FILL AND CAP THE VIALS INSIDE OF A BIOLOGICAL SAFETY CABINET (NEGATIVE FLOW) OR A LAMINAR FLOW WORKSTATION (POSITIVE FLOW). THE BIGGEST PROBLEM WITH THIS IS THAT THESE LITTLE HOODS WITH MOVABLE SASHES ARE VERY HARD TO DISINFECT. LOTS OF INSIDE CORNERS AND PERFORATED METAL. SUCH SURFACES AND THE OLD, DIRTY HEPA FILTER WOULD BE RIGHT UP AGAINST VIAL FILLING AND CAPPING OPERATIONS. I FURTHER GUESS THAT THE FDA GOOD MANUFACTURING PRACTICES (A PART OF THE CODE OF FEDERAL REGULATIONS) DOES NOT ALLOW SUCH LITTLE HOODS TO BE USED FOR FILLING UNLESS THEY CAN BE DISINFECTED WITH VAPORIZED HYDROGEN PEROXIDE. WHEN YOU GET TO THAT LEVEL, YOU ARE BEYOND BIOLOGICAL SAFETY CABINETS AND INTO SOMETHING CALLED EITHER AN ISOLATOR OR A GLOVE BOX. VERY EXPENSIVE EQUIPMENT. TONS MORE TO SAY. THIS WILL DEMONSTRATE THAT PARENTERAL OPERATIONS ARE NOT TO BE LEFT TO VERY SMALL PHARMAS. FUNGUS CONTAMINATION IN PARENTERALS IS UNCOMMON BUT IT HAS HAPPENED BEFORE.

[missssy]

Nobody's going to read your posts when you type in all caps, especially a long rant like this, too hard on the eyes.

[jessicajessicajessica]

i just read it, capslock included....thanks for the info!

[THALES457]

THIS IS ONLY A GUESS. NORMALLY VIAL FILLING IS DONE IN A CLASS 100/ISO 5 LAMINAR FLOW CLEANROOM. SUCH A ROOM IS VERY EXPENSIVE. SO, A LITTLE PHARMA MIGHT POSSIBLE FILL AND CAP THE VIALS INSIDE OF A BIOLOGICAL SAFETY CABINET (NEGATIVE FLOW) OR A LAMINAR FLOW WORKSTATION (POSITIVE FLOW). THE BIGGEST PROBLEM WITH THIS IS THAT THESE LITTLE HOODS WITH MOVABLE SASHES ARE VERY HARD TO DISINFECT. LOTS OF INSIDE CORNERS AND PERFORATED METAL. SUCH SURFACES AND THE OLD, DIRTY HEPA FILTER WOULD BE RIGHT UP AGAINST VIAL FILLING AND CAPPING OPERATIONS. I FURTHER GUESS THAT THE FDA GOOD MANUFACTURING PRACTICES (A PART OF THE CODE OF FEDERAL REGULATIONS) DOES NOT ALLOW SUCH LITTLE HOODS TO BE USED FOR FILLING UNLESS THEY CAN BE DISINFECTED WITH VAPORIZED HYDROGEN PEROXIDE. WHEN YOU GET TO THAT LEVEL, YOU ARE BEYOND BIOLOGICAL SAFETY CABINETS AND INTO SOMETHING CALLED EITHER AN ISOLATOR OR A GLOVE BOX. VERY EXPENSIVE EQUIPMENT. TONS MORE TO SAY. THIS WILL DEMONSTRATE THAT PARENTERAL OPERATIONS ARE NOT TO BE LEFT TO VERY SMALL PHARMAS. FUNGUS CONTAMINATION IN PARENTERALS IS UNCOMMON BUT IT HAS HAPPENED BEFORE.

[Matilda63]

It's also in Arizona, in a big way.

[flossy65]

I have been trying to find out if Arizona was on the list of states affected. I had an injection 2 weeks ago. Do you have any further info regarding Arizona? thanks

[rlhender]

How do you know that it's in Arizona?

[Matilda63]

It's also in Arizona, in a big way.

[ecurb99x]

I had 3 of these injections for my lower back pain. They were extremely painful. The first series helped somewhat. The next two did not. I discontinued further injections as they were so painful. The only thing I got from them was bills from my doctor and from the hospital. 3 months has passed since the last injections and I hope I am clear of getting Meningitis. I have enough problems.

[daphnejmd]

I recently received two of three injections. Because of the severe pain associated with the second injection, the third was decided against. In the past week, I have experienced severe nausea and vomiting and severe abdominal pain. This has subsided though I continue to have periods of nausea with no vomiting. I live in the state of South Carolina. How can I find out if the clinic I used was using the same bottles of the contaminate?

[TheCapeCodCookie]

Ask the clinic. They should be able to tell you the supplier in a heartbeat. This company is NOT "big pharma" and has no middle man. Ask them if they purchase from New England Compounding Center.