ATLANTA — The government has released a customer list for the specialty pharmacy at the center of a national fungal meningitis outbreak.
The Food and Drug Administration on Monday listed the medical practices in each state that got any products since May that were later recalled, and how much each received.
They were all customers of New England Compounding Center of Framingham, Mass. A deadly outbreak of a rare fungal form of meningitis has been tied to steroid shots made by the company since May.
Fourteen medical facilities in Maine were on the list: Blue Hill Memorial Hospital in Blue Hill, Coastal Health and Skin Center in Ellsworth, Cosmetic Enhancement Center of Maine in Portland, Eye Center of Central Maine in Waterville, Eye Medical Group in Portland, Lyndon W. Morgan M.D. in Belfast, Maine Coast Memorial Hospital in Ellsworth, Maine Eye Center in Portland, Maine General Medical Center in Waterville, Midcoast Hospital-Pharmacy in Brunswick, Miles Memorial Hospital in Damartiscotta, St. Joseph Hospital in Bangor and The Well Woman Clinic in Freeport.
Last month, the company recalled the steroid shots that went to clinics in 23 states. That recall was later expanded to all its products, and the lists show they went to a longer list of states.
thanks BDN for that List!
stay tuned! tomorrow they’re going to release the names of the exact medications infected.
Wondering if this is a form of bioterrorism.
I was thinking the same thing.. its HIGHLY unusual for this type of thing to happen with today’s standards and regulations on all medications that are produced. Possibly its a coverup for something the government is trying to not start a panic about?
Compounding pharmacies – like NECC – are not pharmaceutical companies. they are regulated (poorly) by the states, not the federal government.
I have reserved thoughts about a flu shot.
New England Compounding Center product recall list – http://www.fda.gov/Safety/Recalls/ucm322979.htm
I have had two steroid epidurals in the last 4 mths. I go to Dr Herland up on Stillwater ave. Very glad to see that his name is not on the list.
St. Joseph’s Hospital is on the list. Last I knew, this is where he practices and performs most injections.
This is scary. We can imagine it could happen at other facilities as well. What is going to be done to protect people who are prescribed medication? What is done to protect people taking medication made in India for example?
The FDA does its best with the resources it has to regulate drugs from out of the country. However, the FDA has not gotten a budget increase in almost 15 years while the number of things it is responsible for has grown dramatically.
FDA’s budget goes up every year. 2013 budget request is ~ $59million over 2012.
This chart is a little outdated, but shows some of the numbers:
http://www.fdaimports.com/blog/wp-content/uploads/2011/07/FDA-Spending-and-History-Chart-01.png
From Maine Medical Association Posted 10/22/12:
FDA Statement on Fungal Meningitis Outbreak: Additional
Patient Notification Advised
While none of the injectable steroid medication from NECC was
distributed in Maine, the FDA last week recommended that physicians who
administered ANY drug produced by the New England Compounding Center after May
21, 2012 contact the patients and has provided a sample letter to assist. The
FDA acknowledged that it was acting out of an abundance of caution, as there
have been no confirmed reports of infections linked to other products produced
by NECC. Many medical practices in Maine, mostly ophthalmology and cardiology
practices, received products from NECC after May 21.
CDC and FDA have confirmed the presence of a fungus known as Exserohilum
rostratum in unopened medication vials of preservative-free methylprednisolone
acetate (80mg/ml) from one of the three implicated lots from NECC (Lot
#08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid
injections from these lots from NECC to the multistate outbreak of fungal
meningitis and joint infections. Testing on the other two implicated lots of
methylprednisolone acetate and other NECC injectables continues.
CDC and state health departments estimate that approximately 14,000 patients
may have received injections with medication from three implicated lots of
methylprednisolone and nearly 97% of these patients have been contacted for
further follow-up.
There is now available a Patient
Notification Letter on the FDA “Update on Fungal Meningitis” webpage under
the “Related Information” section. This letter template is for healthcare
professionals notifying patients administered a drug produced by the New England
Compounding Center (NECC) that has been recalled.
FDA advises healthcare professionals that if you administered an NECC
injectable product to a patient after May 21, 2012, including an ophthalmic drug
that is injectable or used in conjunction with eye surgery or a cardioplegic
solution, you follow-up with that patient. Healthcare professionals and medical
care organizations should inform patients who received the NECC products noted
above of the symptoms of possible infection and instruct patients to contact
their healthcare provider immediately if they experience any of these
symptoms.
FDA advises healthcare professionals and patients to report adverse events or
side effects related to the use of these products to the FDA’s MedWatch Safety
Information and Adverse Event Reporting Program.
Read the MedWatch Alert, including a link to the FDA Statement here