* Drug used as painkiller in back injections
* Compounding pharmacies primarily regulated by states
* Company has suspended operations
(Updates with quote from Congressman, doctor, description offirm's office)
By Tim Ghianni
NASHVILLE, Tenn., Oct 8 (Reuters) - About 13,000 people in23 U.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.
It was the first time the CDC has given an estimate of thenumber of patients potentially affected, having previously saidonly that it could be in the thousands.
So far, 105 cases of the rare form of meningitis have beenconfirmed in nine states. In worst-hit Tennessee another personhas died, bringing the national death toll to eight, the CDC andTennessee state authorities said on Monday.
The Saint Thomas Outpatient Neurosurgery Center in Nashvillereceived about 2,000 of the 17,676 vials of potentially taintedsteroid, more than any other facility in the country, saidTennessee Health Commissioner Dr John Dreyzehner.
Dealing with patients who received the injections has beenan "horrific experience" in many ways, said Dr Robert Latham,director of the Infectious Diseases Program at Saint Thomas.
"We've seen upwards of 40 to 50 patients a day since lastMonday through the emergency room that have had to beextensively evaluated," he said.
The widening outbreak has alarmed health officials andfocused attention on regulation of pharmaceutical compoundingcompanies such as the one that produced the drugs - the NewEngland 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 they were mobilizingcommunity resources, including sheriff's offices, to check onpatients 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 steroid is used as a painkiller, usually for the back.Meningitis is an infection of the membranes covering the brainand spinal cord. Patients can begin to show symptoms up to amonth after injection.
The potentially tainted drugs were produced as early as May2 1 and shipped to 76 facilities in 23 states through September,the CDC and Massachusetts Health Department said.
The company has suspended its operations while aninvestigation proceeds. It initially recalled the three lots ofthe drug, and expanded its recall on Saturday to all productscompounded and distributed at its Framingham facility.
The address listed in state records for the company is arundown two-storey complex in a scruffy area of Framingham,Massachusetts, Reuters journalists who visited the site said.The journalists who tried to visit the building were ordered offthe property by a security officer.
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 noproblems were found. In March 2012, a complaint was made aboutthe potency of a product used in eye surgery procedures. Thatinvestigation is continuing, state officials said.
The U.S. Food and Drug administration has limited authorityover the operations of compounding pharmacies, which areregulated primarily by state boards that oversee the practices,licensing and certification of pharmacies and pharmacists.
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. The FDA probescases of adulterated drugs in cooperation with state regulators.
The FDA has tried to exert greater authority over compoundeddrug products. But those efforts led to federal court challengesthat resulted in conflicting court rulings.
Massachusetts Democratic Congressman Edward Markey saidcompounders fall into a federal regulatory "black hole."
"If compounding is done on a large scale and is not doneproperly, compounders can expose large numbers of patients tohealth risks associated with unsafe or ineffective medications,"he said in a letter to the FDA on Monday.
The nine states where fungal meningitis cases have beenreported are Florida, Indiana, Maryland, Michigan, Minnesota,North Carolina, Ohio, Tennessee and Virginia.
Tennessee accounted for most of the cases, with 35 and fourdeaths. Virginia has 23 cases and one death, Michigan 21 casesand two deaths and one person has died in Maryland. (Link tographic )
Fungal meningitis symptoms include fever, headache, nauseaand neurological problems 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 .
(Additional reporting by Ros Krasny, Mary Wisniewski and GregMcCune; Editing by David Brunnstrom)
Keywords: USA HEALTH/MENINGITIS