Important Notice to Patients: New England Compounding Center

October 16, 2012

Oct. 16, 2012

Dear Patients:

The following is an update to our notice below. The FDA has advised all institutions that received any injectable medication from the New England Compounding Center (NECC) to advise patients that the sterility of any injectable drug are of “significant concern.” They specifically state that “out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection.”

The Mass. Eye and Ear did use one medications from the NECC for the purposes of anesthesia for eye surgery. We have no evidence that this medication used for these eye surgeries (eye block syringes) had any infectious agent. To be cautious, we are asking any patient who may have concerns to contact their ophthalmologist.

The symptoms of concern for patients who had eye surgery for an infection include visual changes, pain, redness or discharge from the eye. If you have any of these symptoms, please contact your ophthalmologist immediately.

Update on Oct. 22: Letters have been sent by U.S. mail to those patients who had this eye block during their surgeries. If you have questions about what medication you received during your surgery, please contact your physician.

Oct. 9, 2012

Dear Patients:

You may have heard in the news that Framingham based New England Compounding Center (NECC), a compounding pharmacy, has voluntarily stopped operations due to a number of issues, but particularly one that involved contaminated methylprednisolone injection. A number of patients who received this injection for back pain have developed aspergillus meningitis.

The Mass. Eye and Ear has NOT purchased nor used any methylprednisolone from NECC, and this was the only drug identified with an infectious contaminant. Mass. Eye and Ear was NOT impacted by this recall.

We did utilize this pharmacy for our prefilled eye-block syringes. On recommendation from the FDA, we have removed all existing supply from our hospital as of October 5. This was the only drug supplied to us by this compounding pharmacy. We have no reason to believe that there was anything amiss with our supply of drug, but we have removed it to be extra cautious. We now make up our own eye-block syringes here on site.

Please be assured that the safety of our patients is of utmost importance at Mass. Eye and Ear. If you have any questions, please speak with your physician's office.