* Drug used as painkiller in back injections
* Compounding pharmacies primarily regulated by states
* Company has suspended operations
(Updates with more details from Tennessee, explanation of13,000 figure)
By Tim Ghianni
NASHVILLE, Tenn., Oct 8 (Reuters) - Some 13,000 people in 23U.S. states may have received steroid injections linked to arare fungal meningitis outbreak that has killed eight people,but far fewer are likely to contract the disease, the Centersfor Disease Control said on Monday.
The CDC for the first time estimated the number of patientspotentially affected, after previously saying only that it couldbe in the thousands.
So far, 105 cases of the rare form of meningitis have beenconfirmed in nine states. In hardest hit Tennessee anotherperson has died, bringing the national death toll to eight, theCDC and Tennessee state authorities said on Monday.
Nearly 1,000 people in Tennessee may have receivedinjections from the three recalled lots containing 17,676 vialsof potentially tainted steroid, Tennessee Health CommissionerDr. John Dreyzehner said on Monday. Saint Thomas OutpatientNeurosurgery Center in Nashville received some 2,000 vials, morethan any other facility in the country, he said.
The widening outbreak has alarmed federal and state healthofficials and focused attention on regulation of pharmaceuticalcompounding companies such as the one that produced the drugs -the New England Compounding Center Inc in Framingham,Massachusetts.
"We anticipate finding some additional infections," said CDCspokesman Curtis Allen. He could not say if all 13,000 peoplehad been contacted, but said efforts had been made to find themin the last few days and the recall should limit the outbreak.
In Ohio, health officials said on Monday they weremobilizing community resources, including sheriff's offices, tocheck on patients who have received the injections.
"If that means knocking on doors, then that's what they willdo," Beth Bickford, executive director at the Association ofOhio Health Commissioners, said in a statement. The state has sofar reported one case of fungal meningitis likely caused by atainted epidural steroid injection.
The steroid is used as a painkiller, usually for the back.Meningitis is an infection of the membranes covering the brainand spinal cord, and patients started showing a variety ofsymptoms from one to four weeks after their injections.
The potentially tainted drugs were produced as early as Mayand shipped to 76 facilities in 23 states through September, theCDC and Massachusetts Health Department said.
The company, which was previously the subject of complaints,has suspended its operations while an investigation proceeds. Itinitially recalled the three lots of the drug, and expanded itsrecall on Saturday to all products compounded and distributed atits Framingham facility.
A compounding pharmacy takes medications from pharmaceuticalmanufacturers and makes them into specific dosages and strengthsfor use by doctors.
Complaints against the company in 2002 and 2003 about theprocessing of medication resulted in an agreement withgovernment agencies in 2006 to correct deficiencies, theMassachusetts Health Department said.
LIMITED FDA AUTHORITY
In 2011, there was another inspection of the facility and nodeficiencies were found. In March 2012, another complaint wasmade about the potency of a product used in eye surgeryprocedures. That investigation is continuing, the state healthdepartment said.
The U.S. Food and Drug administration has limited authorityover the day-to-day operations of compounding pharmacies, whichare regulated primarily by state boards that oversee thepractices, licensing and certification of pharmacies andpharmacists.
Compounded products do not have to win FDA approval beforethey are sold, and the agency has no jurisdiction over how theproducts are manufactured or labeled for use. Instead, the FDAinvestigates cases of adulterated drugs in cooperation withstate regulators.
The FDA has tried to exert greater authority over compoundeddrug products under a section of the Food, Drug and Cosmetic Actthat covers new drugs. But those efforts led to federal courtchallenges that resulted in two separate and conflicting rulingsat the appellate level.
The nine states where fungal meningitis cases have beenreported are Florida, Indiana, Maryland, Michigan, Minnesota,North Carolina, Ohio, Tennessee and Virginia.
Tennessee, where the outbreak was first detected, accountedfor most of the cases, with 35, including four deaths. Manypatients there remain hospitalized, some in critical condition.
Virginia has 23 cases and one death, Michigan 21 cases andtwo deaths and one person has died in Maryland.
Fungal meningitis is not contagious, the CDC said. Symptomsinclude fever, headache, nausea and neurological problems thatwould be consistent with deep brain stroke.
The steroid was sent to California, Connecticut, Florida,Georgia, Idaho, Illinois, Indiana, Maryland, Michigan,Minnesota, North Carolina, New Hampshire, New Jersey, Nevada,New York, Ohio, Pennsylvania, Rhode Island, South Carolina,Tennessee, Texas, Virginia and West Virginia, the CDC said.
A list of facilities that received vials from the infectedlots can be found via the website .
(Writing by Mary Wisniewski; editing by Greg McCune andMohammad Zargham)
Keywords: USA HEALTH/MENINGITIS