On or before May 21, 2012* the New England Compounding Center (NECC) released 3 vials of Methylprednisolone Acetate (80 mg/ml) that were contaminated with a fungus. It appears these vials were distributed to 16 different states including Florida, with some vials ending up in Pensacola.
NECC is a compounding company. They take a raw drug and place it in vials or solutions that are readily used by healthcare providers. The process, if done properly, is performed under sterile conditions so that pathologic organisms (bacteria, fungi, etc.) are not introduced into the final product. The exact mechanism of failure of this process that caused the introduction of a fungus has not been released, although the investigation is ongoing.
One of the most common pain management treatments is the injection of steroids into the epidural space, which is the space that is outside the covering of the spinal cord, the dura. The steroid used is a depo type steroid that will exert the majority of its anti-inflammatory action at or near the injection site, which is of course where the bulging or ruptured disc is located. The same steroid is often injected into the knee, hip or elbow joints to treat inflammation and arthritis.
When conducted properly, epidural steroid and intra-articular injections are safe and helpful in the treatment of pain. The incidence of a fungal infection from such injections is extremely rare.
As of October 29th, the Centers for Disease Control and Prevention (CDC) has documented 344 cases of fungal meningitis, stroke due to presumed fungal meningitis or other central nervous system-related infections. There have been 25 deaths in the 17 states with reported cases. The majority of the cases have been in Tennessee, Michigan, and Indiana. Florida is 4th in case number, reporting 22 cases with 3 deaths.
If you believe you were given a steroid injection (epidural or joint) prior to May 21, 2012* and you have not already done so, you should contact the physician who administered the injection. At this point, doctors who use methylprednisolone for epidural or intra-articular injections will know if they were using contaminated lots from the NECC. They will check your medical record and determine what lot was administered to you.
If you were administered steroids from a contaminated lot then, under the direction of the physician, you should be evaluated for any signs or symptoms of fungal infection. Your doctor may make the decision to place you on preventative antifungal medication even if you do not have any signs or symptoms, such as:
- New or worsening headache
- Sensitivity to light (photophobia)
- Stiff neck (meningismus)
- New weakness or numbness in any part of your body
- Slurred speech
- Increased pain, redness, or swelling at the injection site
Because of the slow growth of fungal organisms, the patient may not have immediate clinical signs and symptoms of fungal infection. This may take weeks or longer to manifest.
Your physician may take blood or spinal fluid from you to check for infection. Culture of fungi may take a week or more to show signs of infection. Specialized testing that measures minute amounts of fungi DNA may be analyzed by PCR (Polymerase Chair Reaction) at specialized labs.
Your doctor may elect for you to monitor for these symptoms and contact him/her as soon as possible if any of these symptoms develop. According to the Center for Disease Control, these 3 lots may have caused potential exposure to 14,000 patients. As of today, contact has been made with 97% of these patients.
For more information please view the following web sites:
If you or a family member has been infected with a fungus from an epidural or intra-articular injection you should consult an attorney to know your rights. The attorneys at Michles & Booth are prepared to help you. Please call (800) 848-6168.
Timothy D. Brooks, MD
Michles & Booth
* Data provided by CDC