Contaminated epidural steroid injections, which are commonly used to treat back pain in outpatient clinics, have been linked to an outbreak of fungal meningitis. The source of the outbreak has been identified as compounding pharmacy, and all medications have been recalled. However, meningitis has an incubation period of several weeks or months. More illnesses could soon be reported. Complications may also include strokes and fungal joint infections.
UPDATE: Meningitis Lawsuits Against Clinics, Doctors Centralized
February 10, 2015 — Two years after a deadly outbreak of fungal meningitis, lawsuits against clinics and doctors who administered tainted steroid injections have been centralized in a federal Multi-District Litigation (MDL) in Massachusetts. Click here to read more.
December 17, 2014 — The co-founders and 12 employees of New England Compounding Pharmacy (NECC) were arrested early this morning in connection with an outbreak of fungal meningitis in 2012, which killed 64 people and injured 750 in 20 states. Click here to read more.
December 30, 2013 — The bankrupt owners of New England Compounding Center (NECC) have established a $100 million compensation fund to pay off creditors, including hundreds of people who filed fungal meningitis lawsuits. Click here to read more.
October 7, 2013 — A woman in Tennessee has relapsed after she was supposedly cured of her fungal meningitis infection. In June, the NEJM reported a fungal meningitis relapse in an 80 year-old man who was also infected last year. Click here to read more.
May 24, 2013 — An outbreak of fungal meningitis has been linked to contaminated injections manufactured by Main Street Family Pharmacy in Tennessee. At least seven (7) people have been sickened in Illinois and North Carolina. Click here to read more.
January 3, 2013 — At least 30 individuals and families have filed lawsuits against Insight Imaging, a Virginia clinic that administered tainted medicines from NECC. The lawsuits allege that Insight Imaging misrepresented the safety of the medicine by reporting it as Depo-Medrol on bills instead of the generic medicine from NECC. Click here to read more.
January 2, 2013 — At least 620 people have fallen ill and 39 have died. NECC has filed for bankruptcy and will seek to establish a compensation fund for the victims. Click here to read more.
December 6, 2012 — Massachusetts Department of Health sends “cease and desist” orders to 3 more compounding pharmacies in the state after finding safety violations during surprise inspections. Click here to read more.
November 29, 2012 — Consumer advocacy group Public Citizen calls on FDA to re-inspect 16 compounding pharmacies that received warning letters after 2003. Click here to read more.
November 28, 2012 — More than 70 civil lawsuits against New England Compounding Center will be allowed to proceed. Click here to read more.
November 26, 2012 — The current case count from the CDC involves 490 cases of fungal meningitis, 12 peripheral joint infections, and 34 deaths in 19 states. The CDC has also found that more than 70% of new cases since November 4 have been non-meningitis fungal infections. Click here to read more.
November 13, 2012 — FDA expected to request greater authority to regulate compounding pharmacies. Click here to read more.
November 12, 2012 — NECC has expressed support for centralization of nationwide fungal meningitis lawsuits into one court. The CDC reports 438 people have fallen ill and 32 have died in 19 states. Click here to read more.
November 5, 2012 — The nationwide total is 419 illnesses (including 10 joint infections) and 30 deaths in 19 states. As the incubation period ends, it is likely that the number of new cases will taper off. However, people with the disease may continue to require treatment for several months or more.
New England Compounding Center Recalls Medications
Fungal meningitis outbreaks are very rare and very serious. The fungus that has caused this outbreak contaminated epidural steroid injections, which are injected directly into a patient’s spine to treat back pain. If the needle is contaminated with a fungus, the fungus can easily travel to the brain and cause meningitis — an inflammation of the lining of the brain and spinal cord.
The meningitis outbreak was first identified by a physician at Vanderbilt University, Dr. April Pettit. In September 2012, she treated an ill patient who had an unusual fungal infection in her spine. The patient recently had an epidural steroid injection, which could have introduced the fungus into her spine.
Further investigation traced the outbreak to the New England Compounding Center. The company mixes custom medications when they are not commercially available. They have recalled three lots of the steroid injections (methylprednosolone acetate), which were distributed to 75 facilities in 23 states. They have ceased distribution pending further investigation.
As of November 26, 2012, illnesses have been reported in the following states:
- Tennessee (82 illnesses, 13 deaths)
- Maryland (23 illnesses, 1 death)
- Florida (24 illnesses, 3 deaths)
- Virginia (50 illnesses, 2 deaths)
- Michigan (164 illnesses, 8 joint infections, 9 deaths)
- Indiana (55 illnesses, 5 deaths)
- Minnesota (13 illnesses)
- Texas (2 illnesses)
- New Hampshire (32 illnesses, 4 joint infections)
- New Jersey (33 illnesses)
- Ohio (18 illnesses)
- North Carolina (3 illnesses, 1 death)
- South Carolina (1 illness)
- Idaho (1 illness)
- Illinois (2 illnesses)
- Pennsylvania (1 illness)
- New York (1 illness)
- Georgia (1 illness)
- Rhode Island (3 illnesses)
More Medications Linked to Infections
Most of the people who were sickened in the outbreak of fungal meningitis were treated with an epidural steroid injection called methylprednisolone acetate. The U.S. Food and Drug Administration (FDA) has reported that several people have suffered infections after being treated with other medications from New England Compounding Center. So far, the medications of greatest concern include the following:
- Cardioplegic solution (used in open heart surgery)
- Opthalmic drugs (used in eye surgery)
- Triamcinolone acetonide (epidural steroid injection)
Symptoms of Fungal Meningitis
Symptoms of fungal meningitis are often mild at first, and grow gradually worse. Some patients may have only minor symptoms (such as a headache and no fever). If meningitis is suspected, seek emergency medical attention.
The recall of contaminated epidural steroid injections occurred at the end of September 2012. Experts recommend that anyone who had this procedure since May 21, 2012 should watch out for symptoms of fungal meningitis. If symptoms occur, seek medical help immediately.
The CDC reports that several people have suffered strokes when the fungus infects blood vessels. People at risk for fungal meningitis should also watch for symptoms of stroke.
The early symptoms of fungal meningitis may include:
- Worsening headache
- Pain or redness at the injection site
- Neck stiffness
- Muscle weakness or numbness
- Difficulty balancing
- Slurred speech
- Sensitivity to light
- Personality changes
- Confusion, hallucinations
What is Fungal Meningitis?
Fungal meningitis is a rare disease that occurs when fungal spores infect cerebrospinal fluid, and cause inflammation of the meninges, which is the membrane around the spinal cord and brain. Severe cases can cause swelling and fluid in the brain, which can cause brain damage, nerve damage, or death. Several people have had abscesses and strokes due to meningitis. The disease often require intensive medical care and may cause permanent neurological impairment.
This outbreak of fungal meningitis is thought to be caused by the Aspergillus and Exserohilum fungal spores. These are commonly found in leaf mold.
Meningitis requires treatment in a hospital or intensive care unit. Doctors typically administer intravenous anti-fungal medications. Severe cases may be treated with direct administration of anti-fungal medications into the brain. Patients may require treatment for up to six months, and the drugs can have serious complications.