Safety Alerts & Recalls

What does this mean?

The FDA is advising healthcare professionals to follow-up with patients who were administered any injectable medication from or produced by NECC after May 21, 2012, including injectable drugs used along with eye surgery and solutions used during heart surgery.

At this time, the FDA is not advising healthcare professionals to contact patients who have been administered lower risk NECC products such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories.

Patients who believe they received an injection or other product compounded by NECC after May 21, 2012 should watch for the signs and symptoms of infection, including meningitis. The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at 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.

Please contact your doctor if you have any concerns about your medicines or the information contained in this alert.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Advises Doctors to Contact Patients Who Were Given Any Injectable Medicine Made by NECC after May 21, 2012

The Food and Drug Administration (FDA) continues its investigation of the meningitis outbreak linked to the methylprednisolone steroid injections made by New England Compounding Center (NECC). Most recently, the FDA has received a report of a patient with possible meningitis potentially associated with epidural injection (injection into the spine) of an additional NECC product, triamcinolone acetonide. Triamcinolone acetonide is a type of steroid injectable product made by NECC.

To view a full list of products that are being recalled from NECC, please visit: more information here

For the latest FDA update about the meningitis outbreak, please visit: more information here

A list of common questions and answers about this update, can be viewed here: more information here

Source: FDA
Publication Date: 2012-10-17
Last Updated: 2012-10-22

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