NCL Health Issues
A multistate fungal meningitis outbreak has occurred among patients who received an injectable steroid. The New England Compounding Center (NECC) based in Farmingham, MA, distributed contaminated steroid medication, used in spinal epidural injections and to treat joint pain, to outpatient facilities across the country. Upwards of 14,000 patients have been exposed to these contaminated injections, resulting in 328 cases and causing 24 deaths across 23 states.
NCL has issued a statement calling for increased oversight on compounding pharmacies, in order to prevent similar tragedies in the future. Read it here>>>
Traditionally, drug compounding involved pharmacies preparing specific doses of approved medications based on guidance from a health care professional to meet an individual patient’s needs. However, in recent years compounding pharmacy companies are engaging in large scale manufacturing of prescription drugs. The compounding pharmacies are not regulated by the FDA, but at the state level.
In 2007 Senator Edward Kennedy introduced legislation – the Safe Compounding Drug Act - with two Republican senators – Burr (NC) and Roberts (KS) to establish protections for the public to ensure the safety of compounded drugs, but it faced opposition from the compounding pharmacy industry and was not passed.
What’s being done?
The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) have taken steps to notify the public about this outbreak and potential exposures.
CDC Information: http://www.cdc.gov/hai/outbreaks/meningitis.html
FDA Information: http://www.fda.gov/Drugs/DrugSafety/FungalMeningitis/ucm322734.htm
About the investigation
- On September 26, 2012, three lots of steroid compound (methylprednisone acetate) were recalled by NECC due to contamination with a fungus.
- Fungal meningitis is not contagious. This form of meningitis can not be passed from one person to another through contact; only individuals who received the contaminated injection are at risk for developing fungal meningitis.
- The CDC continues to investigate the exact cause of the contamination, how many people have been exposed and how to best inform patients at risk.
- For more information: http://www.cdc.gov/HAI/outbreaks/currentsituation/
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. The severity of meningitis and treatment varies depending on the cause of meningitis; it is important to know the source!
Monitoring for symptoms
- Fungal infections take time to develop. Symptoms can be seen anywhere from 1 to 6 weeks after exposure. However, shorter and longer periods of time between receiving the injection and the onset of symptoms can occur. It is important to know the symptoms and monitor yourself and others, if you think you might be at risk. As always, contact your health care professional right away if you have any concerns or symptoms.
Symptoms of Fungal Meningitis [Adapted from the CDC].
If you had an epidural steroid injection since May 21, 2012, and have any of the following symptoms, see your health care professional as soon as possible (www.cdc.gov):
- New or worsening headache
- 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
Symptoms of Joint Infection
Individuals who received injections for joint pain should monitor symptoms as the CDC is investigating possible contamination with these injections as well. If you have any of the following symptoms, see your health care provider as soon as possible:
- Increased pain
- Redness, warmth, or swelling in the joint that received the injection or at the injection site.
Where is the Outbreak?
- Outpatient facilities in 23 states have received the contaminated steroid injections.
- CDC list of affected facilities that have received the tainted steroid lots. FDA list of all NECC customers who received products from NECC since May 21, 2012.
- Current Case Count Map
Other Information Related to the Outbreak
- Patient Guidance. The CDC has compiled up-to-date information regarding the outbreak and provides further information on specifics for concerned patients. English Version Spanish Version
- Food and Drug Administration Activities. FDA keeps consumers up to date on the situation with the NECC and meningitis outbreak. http://www.fda.gov/Drugs/DrugSafety/FungalMeningitis/ucm322734.htm.
- Joint Press Briefing on Outbreak with CDC, FDA and Massachusetts Department of Health. Read the transcript of the briefing where government officials answered questions regarding this outbreak.