FDA alerts health providers about other drugs from meningitis-linked pharmacy | News
(KFVS)- The FDA is alerting health providers across the U.S. who received products from the New England Compounding Center (NECC) about new recommendations from the U.S. Food and Drug Administration (FDA) concerning the multistate outbreak of fungal meningitis.
"2 years ago no one had heard of this company," John Chaney, a pharmacist, said. "It's an outspring of the drug shortages we have been talking about."
This second recall from the NECC includes all products produced at the facility.
"In a case like this, it becomes less about the detective work to find out what happened," Dr. Erica Kaufman, an infectious disease specialist, said. "It's more about the very tedious work of tracking patients, tracking lot numbers, and going through medications."
The FDA released a list of facilities that receive products from NECC.
Local facilities include:
- Center for Medical Arts, 2370 N McCoy Drive, Carbondale, IL 62901
- Crossroads Community Hospital, 8 Doctors Park, Mt. Vernon, IL 62864
- Hamilton Memorial Hospital, 611 South Marshall Ave. Mcleansboro, IL 62859
- Heartland Regional Medical Center, 3333 W. Deyoung, Marion, IL 62959
- Herrin Hospital, 201 South 14th Street, Herrin, IL 62948
- Marion Eye Centers & Optical, 1304 Scottsboro Road, Marion, IL 62959
- Marion Eye Surgery Center, 2900 Broadway, Suite B, Mt. Vernon, IL 62864
- Memorial Hospital of Carbondale, 405 W. Jackson, Carbondale, IL 62902
- Memorial Hospital of Carbondale]Cardio, 405 West Jackson Street, Carbondale, IL 62902
- Physicians' Surgery Center LLC, 2601 West Main Street Carbondale, IL 62901
- Pain Management Center of Paducah, 2831 Lone Oak Road, Paducah, KY 42003
- Western Baptist Hospital, 2501 Kentucky Ave. Paducah, KY 42003
- Western Baptist Hospital]Cardio, 2501 Kentucky Avenue, Paducah, KY 42003
Because of concern about possible contamination of additional medications, the FDA is requesting health providers contact patients who meet all the following criteria:
- The medication was shipped by NECC on or after May 21, 2012, and
- The medication was any injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution, and
- The medication was administered to patients on or after May 21, 2012.
The FDA provides the following advice for customers, patients, and healthcare professionals.
Advice to NECC Customers
Customers identified on these lists should check their stocks to identify whether they have any products from the New England Compounding Center (NECC), and they should immediately isolate any identified product from their drug supplies. All NECC products are subject to voluntary recall. Customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.
Advice to Patients
Patients who believe they received an injection or other product that was shipped by NECC on or after May 21, 2012 should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned. The meningitis outbreak has occurred in patients who received injections near the spine (back or neck). The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for infections following other types of injections at other body sites may vary, and are not limited to meningitis. Other possible infections at other parts of the body (e.g., peripheral joints) may include fever; swelling, increasing pain, redness, warmth at an injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest). Patients should contact their healthcare provider if they have any of these signs or symptoms.
Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date. FDA is not recommending these patients follow-up with their healthcare providers unless they are experiencing symptoms of infection.
Advice to Healthcare Professionals
FDA advises healthcare professionals to follow-up with patients who have been administered an injectable product shipped by NECC on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution. FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories, or for patients who may have received an NECC product in these categories before May 21, 2012. Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date. FDA is not recommending that healthcare providers follow-up with these patients unless they have reported symptoms of infection.
Health care professionals should retain and secure all remaining products purchased from NECC. All NECC products are subject to voluntary recall. Clinics or customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.
Clinicians and patients are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.
Healthcare professionals and patients may dial FDA's Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.
If you have identified NECC customers who received product that do not appear on these lists, please contact FDA's Drug Information Line to report this problem.
FDA continues its investigation and may issue additional public communications as appropriate.
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