Meningitis Outbreak due to Contaminated Medications - Update 10/17/2012

As new meningitis cases caused by contaminated epidural steroid injections continued to be reported throughout the country, the Food and Drug Administration (FDA) announced on Monday, October 15, that it is asking physicians and facilities to notify any patient who has received injections of any products produced by the New England Compounding Center (NECC) after May 21, 2012.

Previously, the FDA and Centers for Disease Control (CDC) issued an alert regarding patients who received a specific steroid from the company that has now been linked to more than 200 cases of meningitis. None of the facilities where our physicians perform injections used this specific steroid.

However, the FDA now has concerns about the sterility of NECC’s processes, and the October 15 alert is directed toward a broader group of patients treated with several additional medications produced by the NECC. While most of the facilities where we work do not order material from NECC, patients who received injections of any NECC material at the Christ Hospital Spine Surgery Center will need to watch for any symptoms of possible infection.

The Christ Hospital Spine Surgery Center is sending a letter of notification this week to all identified patients who received injections of NECC material after May 21 and up to October 3 (the date that all NECC material was pulled from inventory). The letter will include important steps to follow should they experience symptoms similar to those of meningitis. It is important to note that The Surgery Center has not used the specific steroid linked to more than 200 cases of meningitis, but has used other medications provided by the NECC. The notification is a cautionary measure.

Patients who received epidural steroid injections from other facilities where Mayfield physicians perform epidural steroid injections do not need to be concerned. Those facilities, including Mayfield’s Northern Kentucky Pain Procedure Suite in Crestview Hills, TriHealth and Mercy facilities, and Christ Hospital facilities other than the Spine Surgery Center, do not use material developed or distributed by NECC.

Patient Recommendations:
The safety and welfare of our patients and the general public is always our first priority. We offer the following recommendations to anyone who is concerned about this:

1. Note that the symptoms of meningitis are similar to those of the flu for most adults and often develop over the course of a few hours or up to two days. If you experience any of the following symptoms, we recommend that contact your primary care physician or go to the emergency room for immediate evaluation:

• Fever
• Headache
• Stiff neck
• Vomiting or nausea
• Sensitivity to light
• Altered mental status

2. We recommend that you contact the facility where you received your injection if you would like more specific information about your injection material. They will have more specific information about the material used in your case.

As always, we will continue to monitor the situation. We will notify our patients should new information arise that could affect them.

Thank you.