* Most news cases in Michigan
* Thousands of patients may have received injections
(Adds details, background) By Tim Ghianni
NASHVILLE, Tenn., Oct 7 (Reuters) - U.S. health officials onSunday reported an additional 27 cases in a fungal meningitisoutbreak linked to steroid injections that has killed sevenpeople and now affected 91 in nine states.
The U.S. Centers for Disease Control and Prevention (CDC)reported a new total of 91 cases in an update on its website, upfrom 64 on Saturday. Most of the new cases were reported inMichigan, where the total increased to 20 from five. Virginia'stotal increased to 18 from 11.
The widening outbreak has alarmed U.S. health officials andfocused attention on regulations of pharmaceutical compoundingcompanies like the one that produced the drugs, the New EnglandCompounding Center Inc in Framingham, Massachusetts.
The company shipped 17,676 vials of the steroidmethylprednisolone acetate to 76 facilities in 23 states fromJuly through September, the Massachusetts Health Departmentsaid.
The steroid is used as a painkiller, usually for the back,and could have been injected in thousands of patients,authorities have said.
Meningitis is an infection of the membranes covering thebrain and spinal cord, and affected patients started showing avariety of symptoms from one to four weeks after theirinjections.
The company, which was previously the subject of complaints,said it suspended its operations while an investigation proceedsand has recalled the three lots of the drug.
A compounding pharmacy takes medications frompharmaceuticals manufacturers and makes them into specificdosages and strengths for use by doctors.
Complaints against New England Compounding Center (NECC) in2002 and 2003 about the processing of medication resulted in anagreement with government agencies in 2006 to correctdeficiencies, the Massachusetts 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 cases have been reported 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 32, including three deaths. Manypatients there remain hospitalized, some in critical condition.
Michigan had 20 cases and two deaths. One person died inMaryland and another in Virginia, the CDC said.
Reuters had reported 65 cases on Saturday, including oneadditional case after the CDC published its total.
This form of meningitis is not contagious, the CDC said.Symptoms include fever, headache, nausea and neurologicalproblems that would 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, Virginia, Texas and West Virginia, the CDC said.
A list of facilities that received vials from the infectedlots can be found online via the website cdc.gov.
(Addional reporting by David Morgan; Editing by Daniel Trottaand Vicki Allen)
Keywords: HEALTH MENINGITIS/