Information for Patients: Multistate Outbreak of Fungal Meningitis and Other Infections

Background

The Centers for Disease Control and Prevention (CDC), in collaboration with state and local health departments and the Food and Drug Administration (FDA), is investigating a multistate outbreak of fungal infections among patients who received contaminated steroid injections.

The infections identified as part of this investigation include fungal meningitis, a form of meningitis that is not contagious, localized spinal or paraspinal infections, and infections associated with injections in a peripheral joint space, such as a knee, shoulder, or ankle.

Is there new information I should be aware of?

In the early stages of the outbreak, the majority of patients were diagnosed with meningitis. Now, more than 4 months after the steroid medication was recalled, the majority of infections being reported to CDC are in patients with localized spinal or paraspinal infections (e.g., epidural abscess). These types of infection are typically diagnosed through Magnetic Resonance Imaging (MRI) of the spine.  CDC has issued guidance for clinicians about this development.

Patients who have received a spinal or paraspinal injection with the contaminated product and have continued, worsening, or new symptoms at or near the site of their injection, should see their doctor for the possibility of a localized infection. This includes patients who initially received steroid injections for pain and continue to have persistent baseline pain.

More information about the Current Situation is available here.

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Localized spinal or paraspinal infection

During this outbreak, some patients have developed spinal or paraspinal infections at the injection site, such as epidural abscess or arachnoiditis. These conditions can occur on their own or in addition to meningitis.

• A spinal epidural abscess is characterized by inflammation and a collection of pus around the spine. Spinal epidural abscesses sometimes result in swelling in the affected area (e.g., near the site where contaminated steroid mediation was injected).
• Common symptoms can include fever, headache, back pain, and neurological problems (e.g., weakness, unusual changes in sensation)
• Arachnoiditis is a disorder caused by the inflammation of the arachnoid, one of the membranes that surrounds and protects the nerves of the spinal cord. The condition can be caused by irritation from chemicals, infection, or direct injury to the spine.
• Symptoms can include numbness, tingling, and a characteristic stinging and burning pain in the lower back or legs. Some people with arachnoiditis may have debilitating muscle cramps, twitches, or spasms. The condition may also affect the bladder, bowel, and sexual function. In severe cases, arachnoiditis may cause paralysis of the lower limbs.

If you got a spinal or paraspinal injection from one of the three recalled lots of preservative-free methylprednisolone acetate (MPA) and have continued, worsening, or new symptoms at or near the site of your injection, you should see your doctor for the possibility of a localized infection such as an epidural abscess. This includes patients who initially received steroid injections for pain and continue to have persistent baseline pain.

Fungal Meningitis

What is meningitis?

Meningitis is swelling of the protective membranes, or meninges, covering the brain and spinal cord. The swelling is usually caused by an infection with a bacteria or virus, but meningitis can also be caused by a fungus. Meningitis caused by a fungus is called fungal meningitis. The severity of illness and the treatment for meningitis differ depending on the cause, so knowing the specific cause of meningitis is important.

What is fungal meningitis?

Fungal meningitis occurs when the protective membranes covering the brain and spinal cord are infected with a fungus. Fungal meningitis is rare and usually caused by the spread of a fungus through blood to the spinal cord.

Symptoms of fungal meningitis

During this outbreak, many patients with fungal meningitis had only a few mild symptoms. Most had headache, and some have had fever, nausea, and light sensitivity. Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop.

If you had a steroid injection since May 21, 2012, and have any of the following symptoms, talk to your doctor as soon as possible.

• New or worsening headache
• Fever
• Sensitivity to light
• Stiff neck
• New weakness or numbness in any part of your body
• Slurred speech
• Increased pain, redness or swelling at your injection site

Is fungal meningitis contagious?

No, fungal meningitis is not transmitted from person to person. The current outbreak is associated with contaminated medication that is injected into the body.

Is fungal meningitis common after spinal injections?

Spinal injections are generally very safe procedures, and complications are rare. Fungal meningitis is an extremely rare cause of meningitis overall, including after spinal injections. The type of epidural medication given to patients affected by this outbreak is not the same type of medication as that given to women during childbirth.

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Fungal Joint Infection

Symptoms of Joint Infections

If you were injected with preservative-free methylprednisolone acetate recalled on September 26, remain vigilant for onset of symptoms because fungal infections can be slow to develop. See a doctor if you have any of the following symptoms:

• Fever
• Increased pain
• Redness, warmth, or swelling in the joint that received the injection or at the injection site

About the Outbreak Investigation

How many cases have been reported?

Updates about the investigation, including case counts, are available at http://www.cdc.gov/hai/outbreaks/meningitis.html.

Is the source of the outbreak known?

Three lots of preservative-free methylprednisolone acetate (MPA), an injectable steroid medication recalled on September 26, 2012, from the New England Compounding Center (NECC), have been linked to the outbreak. The type of spinal epidural medication given to patients affected by this outbreak is not the same type of medication as that given to women during childbirth.

Which states received the three lots of contaminated steroid medication associated with the outbreak?

Twenty-three states received the three lots of contaminated steroid medication from the New England Compounding Center (NECC). All clinics that received the contaminated recalled steroid medication are listed on the Current State Facility page.

Where can I find updates and additional information on this outbreak?

For complete information and updates on CDC's outbreak website, visit www.cdc.gov/hai/outbreaks/meningitis.html.

For complete information and updates on FDA's outbreak website, visit http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm

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What Should Patients Know?

How do I know if the clinic I got my injection from used contaminated steroid medicine?

All clinics that received the three lots of contaminated steroid medication are listed on the Current State Facility page.

To find out if your facility was one of the ones that received the medication,

• Go to the Current State Facility page.
• Find your state.
• See if the name of the clinic where you got your injection is listed.

Are medications other than the three recalled lots of steroid medications from the New England Compounding Center (NECC) associated with infections?

CDC and FDA have identified bacteria and/or fungi in additional products from NECC. To date, although CDC has received reports of illness in patients who received these medications, including some patients who had evidence of meningeal inflammation, CDC and public health officials have no reports of laboratory-confirmed bacterial or fungal meningitis, spinal, or paraspinal infections caused by these products. The available epidemiologic and laboratory data do not, at this time, support evidence of an outbreak of infections linked to usage of NECC products other than the contaminated steroid medications (methylprednisolone).

If you have taken or used any medication from NECC and feel sick, you should seek medical attention. Any infections potentially related to NECC products should be reported to FDA Medwatch and to your state health department.

Information on this site is focused on the three lots of preservative-free methylprednisolone acetate (MPA) from NECC associated with the outbreak of fungal meningitis and other infections. For information on other recalled medication from NECC, see Information about Additional Medical Products (non-MPA) From New England Compounding Center FAQs.

Why did some people who received an injection with one of the three lots of the contaminated steroid get sick and not others?

CDC's investigation is ongoing, but the information available suggests that it is likely that not everyone who got an injection will get sick. Why one person may get sick and another person may not is unknown. However, underlying health conditions, circumstances surrounding the patient's injection, and level of contamination of the particular vial of medication used in the injection may influence if a person gets sick.

Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop. More than 4 months after the three lots of contaminated steroid were recalled, CDC continues to receive reports of infection. The majority of infections currently being reported to CDC are patients with localized spinal and paraspinal infections (e.g., epidural abscess). Patients and physicians need to continue to closely watch for symptoms for several months following the injection. Signs and symptoms of a localized infection may be difficult to distinguish from a patient's baseline pain.

Contact your physician if you have received a spinal or paraspinal injection with the implicated medicine and have continued, worsening, or new symptoms at or near the site of your injection. This includes patients who initially received steroid injections for pain and continue to have persistent baseline pain.

Are other injectable medications, like vaccines, safe?

The fungal meningitis outbreak from contaminated steroid medication is completely unrelated to vaccines. Vaccines available in the United States are held to the highest quality standards by the Food and Drug Administration (FDA), and each batch (called "lot") of vaccine must be approved by FDA before it is available for the public. FDA also inspects U.S. vaccine manufacturing facilities to ensure that the highest standards are being met and that no contamination of vaccines occurs. Vaccines have had an excellent safety record with hundreds of millions of people in the United States getting them safely for many years.

CDC and FDA work closely to monitor the safety of vaccines. See CDC's Vaccine Safety site for more information. Vaccine schedules can be found on CDC's Immunization Schedules site.

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What If I Have Been Given a Steroid Injection?

I was contacted because I received a spinal injection with preservative-free methylprednisolone acetate recalled on September 26, but I feel fine. Do I still need to be concerned?

Yes. You should watch for onset of symptoms because fungal infections can be slow to develop. More than three months after the three lots of contaminated steroid were recalled, CDC continues to receive reports of infection. The majority of infections currently being reported to CDC are patients with localized spinal and paraspinal infections (e.g., epidural abscess). Patients and physicians need to continue to closely watch for symptoms for several months following the injection. Signs and symptoms of a localized infection may be difficult to distinguish from a patient’s baseline pain.

Contact your physician if you have received a spinal or paraspinal injection with the implicated product and have continued, worsening, or new symptoms at or near the site of your injection. This includes patients who initially received steroid injections for pain and continue to have persistent baseline pain

If I received a spinal injection with a contaminated steroid but I feel fine, do I need to begin antifungal treatment?

CDC does not recommend antifungal treatment for people who received a contaminated steroid injection, but who do not have any symptoms and do not have laboratory evidence of infection. You should talk to your doctor if you have concerns or are experience pain.

I was contacted because I received a joint injection with preservative-free methylprednisolone acetate recalled on September 26, but I feel fine. Do I still need to be concerned?

This investigation is ongoing and joint infections from fungus may take longer to develop than fungal meningitis. Patients who have had steroid medications injected in joints only are not at risk for fungal meningitis but could be at risk for joint infection. If you were injected with preservative-free methylprednisolone acetate recalled on September 26, remain vigilant for onset of symptoms and remember that fungal infections can be slow to develop. See a doctor if you have symptoms.

I have not been contacted by my doctor and my facility is not on the list, but I have symptoms. What do I do?

If you feel ill, you should contact your doctor.

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Resources and Links

• Multistate Fungal Meningitis Outbreak Investigation
• CDC Fungal Diseases
• CDC Fungal Meningitis
• Aspergillosis
• Exserohilum

U.S. Food and Drug Administration (FDA)

• FDA Statement on Fungal Meningitis Outbreak
• Questions and Answers on Fungal Meningitis Outbreak
• List of Recalled Products Related to Fungal Meningitis Outbreak⁶
• Alert – New England Compounding Center Product Recall Information (Commonwealth of Massachusetts) [PDF - 4 pages]
• FDA: The Special Risks of Pharmacy Compounding

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