New England Compounding Center (NECC), a compounding pharmacy located in Massachusetts, has been identified as the source of contaminated steroid injections that have caused an outbreak of non-contagious fungal meningitis. Hundreds of people have been sickened, at least two dozen have died, and the outbreak continues to grow.
January 2, 2012 — At least 620 people have fallen ill and 39 have died. NECC has filed for bankruptcy and will seek to establish a compensation fund for the victims. Click here to read more.
November 26, 2012 — The CDC is reporting that 490 people have been diagnosed with meningitis, 12 people have been diagnosed with peripheral joint infections, and 34 people have died in 19 states. Most new cases since November 4 have involved non-meningitis fungal infections. Click here to read more.
November 12, 2012 — NECC has expressed support for centralization of nationwide fungal meningitis lawsuits into one court. The CDC reports 438 people have fallen ill and 32 have died in 19 states. Click here to read more.
November 5, 2012 — The nationwide total is 419 illnesses (including 10 joint infections) and 30 deaths in 19 states. As the incubation period ends, it is likely that the number of new cases will taper off. However, people with the disease may continue to require treatment for several months or more.
October 26, 2012 — The outbreak of fungal meningitis continues to spread, with more cases of joint infections. The CDC reports a total of 338 infections, including 7 peripheral joint infections and 331 cases of meningitis, stroke, or central nervous system infection. Of these, at least 25 people have died in 18 states.
October 25, 2012 — The CDC is reporting 328 infections linked to contaminated medicines (including 5 peripheral joint infections and 323 cases of fungal meningitis, stroke, or infection) including 24 deaths in 18 states.
October 24, 2012 — The CDC reports that, nationwide, 317 people have been infected (312 cases of fungal meningitis, stroke, or central nervous system infection, and 5 cases of peripheral joint infections), 24 people have died in 17 states.
October 23, 2012 — Nationwide, the CDC is reporting 308 cases (including 304 cases of fungal meningitis, stroke, or other central nervous system infection, and 4 cases of peripheral joint infections). Of these, 23 people have died in 17 states.
October 22, 2012 — The CDC is reporting that the number of illnesses has grown to 297 (including 294 cases of fungal meningitis and 3 peripheral joint infections) and 23 deaths. The number of states involved remains at 16.
October 19, 2012 — The CDC is reporting that, nationwide, 271 people have fallen ill (including 268 cases of fungal meningitis or stroke, and 3 joint infections). Of these, at least 21 have died. 16 states are involved in the outbreak.
October 17, 2012 — Nationwide, 247 people have fallen ill (including 245 cases of fungal meningitis, stroke, or other central-nervous system fungal infection; and 2 joint infections). Of these, 19 people have died in 15 states.
October 15, 2012 — The FDA has identified 3 possible cases of fungal infections caused by other medicines from New England Compounding Center (NECC), in addition to methylprednisolone acetate that has been linked to hundreds of illnesses. The other medicines are triamcinolone acetonide (a type of epidural steroid shot) and cardioplegic solution (commonly used during heart surgery). Click here for more information.
New England Compounding Center Recall
A preliminary investigation from the Centers for Disease Control (CDC), the Food and Drug Administration (FDA), and several state health departments has traced an outbreak of fungal meningitis to epidural steroid injections from New England Compounding Center.
On September 26, 2012, New England Compounding Center issued a voluntary recall of three lots of methylprednisolone acetate, an epidural steroid injection commonly used to treat back pain in outpatient clinics. On October 5, 2012, the company expanded the recall to include all lots of all medications sold by the company — approximately 1,200 drugs and medical products. The company has rescinded their pharmacy license and shut down the facility.
The epidural steroid injections in question were sold to at least 75 clinics in 23 states. An estimated 13,000 people may have received injections with the recalled products. More than one hundred people have been sickened and at least a dozen have died.
What is a compounding pharmacy?
Compounding pharmacies create custom medications that are not available commercially — modern-day apothecaries, essentially. For example, a compounding pharmacy might take a solid medication and turn it into a liquid for a patient who cannot swallow. Or, they might mix a medication for a patient who is allergic to a certain ingredient. They also provide medications during drug shortages.
In the past, compounding pharmacies were small-scale operations, often located in hospitals. However, there is an increasing number of compounding pharmacies that wholesale bulk medications, like small-scale pharmaceutical companies, because they can often provide the drugs much more cheaply than large pharmaceutical companies. A growing number of compounding pharmacies operate factories that mass-produce drugs and sell them across state lines, even when there are no drug shortages.
Are compounding pharmacies regulated by the FDA?
Compounding pharmacies are in a regulatory limbo between 50 different state pharmacy boards and the federal U.S. Food and Drug Administration (FDA). Although the FDA can step in and provide oversight in specific cases (such as during an outbreak), most oversight powers are in the hands of pharmacy boards. Unfortunately, experts say pharmacy boards lack the resources and expertise to inspect compounding pharmacies effectively. Furthermore, medicines produced by compounding pharmacies do not need to be evaluated for safety and effectiveness by the FDA.
New England Compounding Center Recalled Products
The following facilities have recalled epidural steroid injections from New England Compounding Center:
|CYPRESS SURGERY CENTER DBA||559 740 4094||VISALIA||CA|
|ENCINO OUTPATIENT SURGICENTER||818-986-1037||ENCINO||CA|
|UKIAH VALLEY MEDICAL CENTER||707 463 7345||UKIAH||CA|
|UNIVERSAL PAIN MANAGEMENAT||661-267-6876 x166||PALMDALE||CA|
|INTERVENTIONAL SPINE AND SPORTS MED||203 598 7246||MIDDLEBURY||CT|
|FLORIDA PAIN CLINIC||352-237-5906||OCALA||FL|
|INTERVENTIONAL REHAB CENTER||850 484 8800||PENSACOLA||FL|
|MARION PAIN MANAGEMENT CENTER||352 622 1845||OCALA||FL|
|NORTH COUNTY SURGICENTER||561 626 6446||PALM BEACH GARDENS||FL|
|ORLANDO CENTER FOR OUTPATIENT SURGERY||407-426-8331||ORLANDO||FL|
|PAIN CONSULTANTS OF WEST FLORIDA||850 494 0000||PENSACOLA||FL|
|SURGERY CENTER OF OCALA||352-237-5906||OCALA||FL|
|SURGICAL PARK CENTER||305-271-9100 x226||MIAMI||FL|
|FORSYTH STREET AMBULATORY SURG. CTR.||478-749-1610||MACON||GA|
|PAIN SPECIALISTS OF IDAHO||208 522 7246||IDAHO FALLS||ID|
|WALTER KNOX MEMORIAL HOSPITAL||208-365-3561 x3342||EMMETT||ID|
|APAC CENTERS FOR PAIN MANAGEMENT||708-483-7007||WESTCHESTER||IL|
|APAC CENTERS FOR PAIN MANAGEMENT-||773-935-2760||CHICAGO||IL|
|THOREK MEMORIAL HOSPITAL||773 975-6734||CHICAGO||IL|
|AMBULATORY CARE CENTER LLC||812 475 1800||EVANSVILLE||IN|
|FORT WAYNE PHYSICAL MEDICINE||260-436-9337||FORT WAYNE||IN|
|OSMC OUTPATIENT SURGERY CENTER||574-266-4173||ELKHART||IN|
|SOUTH BEND CLINIC||574-237-9372||SOUTH BEND||IN|
|UNION HOSPITAL–||812 238 4964||TERRE HAUTE||IN|
|BALTIMORE PAIN MANAGEMENT||410 682-5040||BALTIMORE||MD|
|BERLIN INTERVENTIONAL PAIN MANAGEMENT||410 641 3759||BERLIN||MD|
|BOX HILL SURGERY CENTER||410 877 8141||ABINGDON||MD|
|GREENSPRING SURGERY CENTER||410 653 0077||BALTIMORE||MD|
|HARFORD COUNTY ASC, LLC||410 538 7000||EDGEWOOD||MD|
|PAIN MEDICINE SPECIALISTS||410 825 6945||TOWSON||MD|
|SURGCENTER OF BEL AIR||410 638 5523||BEL AIR||MD|
|MICHIGAN NEUROSURGICAL INST.||810 606 7112||GRAND BLANC||MI|
|MICHIGAN PAIN SPECIALISTS||734 995 7246||BRIGHTON||MI|
|NEUROMUSCULAR & REHABILITATION||231 935 0860||TRAVERSE CITY||MI|
|SOUTHEAST MICHIGAN SURGICAL HOSPITAL||586-427-1000||WARREN||MI|
|MAPS-EDINA MEDICAL PAIN CLINIC||763 537 6000||MINNEAPOLIS||MN|
|MAPS-MEDICAL ADVANCED PAIN||763 537 6000||FRIDLEY||MN|
|MEDICAL ADVANCED PAIN SPECIALISTS*||763-537-6000 x238||SHAKOPEE||MN|
|MEDICAL ADVANCED PAIN SPECIALISTS.||763 537 6000||MAPLE GROVE||MN|
|MINNESOTA SURGERY CENTER||763-767-7139||EDINA||MN|
|MINNESOTA SURGERY CENTER-||763 537 6000||MAPLE GROVE||MN|
|HIGH POINT SURGERY||336 878 6048||HIGH POINT||NC|
|NORTH CAROLINA ORTHOPAEDIC CLINIC||919 403 5148||DURHAM||NC|
|SURGERY CENTER OF WILSON||252-237-5649||WILSON||NC|
|DR. O’CONNELL’S PAIN CARE CTR||603-335-5070||MERRIMACK||NH|
|DR. O’CONNELL’S PAINCARE CENTERS, INC||603 692 3166||SOMERSWORTH||NH|
|CENTRAL JERSEY ORTHOPEDICS SPECIALISTS PC||908 561 2122||SOUTH PLAINFIELD||NJ|
|EDISON SURGICAL CENTER||732 452 0123||EDISON||NJ|
|IF PAIN ASSOCIATES / ISAIAH FLORENCE||201 287 1100||TEANECK||NJ|
|PREMIER ORTHOPEDICS SURG. ASSOC., LLC||856 690 1750||VINELAND||NJ|
|Comprehensive Pain Management||973 796 5216||SPARTA||NJ|
|SOUTH JERSEY HEALTH CARE||856 363 1558||ELMER||NJ|
|SOUTH JERSEY HEALTHCARE||856-641-7557||VINELAND||NJ|
|SAHARA SURGERY CENTER||702-362-7874||LAS VEGAS||NV|
|BUTANI, SUNIL H. PHYSICIAN PC||516 747 5042||MINEOLA||NY|
|OBOSA MEDICAL SERVICES||914-530-2323||MOUNT VERNON||NY|
|ROCHESTER BRAIN AND SPINE||585 334 5560||ROCHESTER||NY|
|BKC PAIN SPECIALISTS,LLC||740-387-7246||MARION||OH|
|CINCINNATI PAIN MANAGEMENT||513 891 0022||CINCINNATI||OH|
|MARION PAIN CLINIC||740-375-0200||MARION||OH|
|ORTHO-SPINE REHAB. CENTER, INC.||DUBLIN||OH|
|ALLEGHENY PAIN MANAGEMENT||814-940-2000 X 500||ALTOONA||PA|
|SOUTH HILLS PAIN & REHAB ASSOC.||412 469 7722||JEFFERSON HILLS||PA|
|NEW ENGLAND ANESTHESIOLOGY (NEA)||401-490-7530||WARWICK||RI|
|OCEAN STATE PAIN MANAGEMENT||401 766 7700||WOONSOCKET||RI|
|OCEAN STATE PAIN MANAGEMENT-||401 884 6070||EAST GREENWICH||RI|
|INTERVENE MD||843-216-4844||MOUNT PLEASANT||SC|
|PCA PAIN CARE CENTER-||865 835 5196||OAK RIDGE||TN|
|SPECIALTY SURGERY CENTER||931-484-2500 x125||CROSSVILLE||TN|
|ST. THOMAS OUTPATIENT NEUROSURGIACL||615 341 3433||NASHVILLE||TN|
|DALLAS BACK PAIN MANAGEMENT||214 445 5077||DALLAS||TX|
|HARRIS METHODIST SOUTHLAKE CENTER||817 748 8778||SOUTHLAKE||TX|
|INSIGHT IMAGING-ROANOKE||540 581 0882||ROANOKE||VA|
|NEW RIVER VALLEY SURGERY CENTER||540 639 5888||CHRISTIANSBURG||VA|
|PARS INTERVENTIONAL PAIN||304 865 7277||PARKERSBURG||WV|