UPDATE 2-Medication tied to rare meningitis outbreak may have reached 23 states
* Tennessee is hardest-hit state
* Steroid used mainly to control back pain
(Updates with comments from expert)
By Tim Ghianni
NASHVILLE, Tenn., Oct 4 (Reuters) - A steroid medicationlinked to the death of at least five people from rare fungalmeningitis may have been administered to patients in 23 states,the U.S. Centers for Disease Control said on Thursday, raisingfears the rare outbreak could spread.
In a briefing for reporters, the CDC said five people haddied so far and 35 had fallen sick from fungal meningitis in sixstates. The outbreak was first reported in Tennessee, wherethree people have died and 25 of the cases have been reported.
The other confirmed deaths were in Virginia and Maryland.
"We do know there were over 700 patients in Tennessee whowere exposed," said Dr. William Schaffner, an infectious diseaseexpert at Vanderbilt University School of Medicine in Nashville,who said the number was provided to him by Tennessee statehealth officials.
The CDC said it had not yet determined the rate of infectionamong those patients who received the potentially taintedsteroid. The rate of infection is an important barometer of thepotential for the outbreak to spread.
"At the moment, fortunately, the attack rate looks prettylow - less than 1 percent -- but we are still in the early daysof defining this thing," Schaffner said.
The steroid is administered to patients, usually byinjection, primarily to control back pain.
All the cases have so far been traced to three lots ofMethylprednisolene Acetate from a pharmaceutical compoundingplant in Massachusetts, according to the briefing.
The company, New England Compounding Center Inc, or NECC, inFramingham, Massachusetts, prepared the medication, which hasbeen voluntarily recalled. The company has also voluntarilysurrendered its license.
Attempts to view the NECC website prompted a "temporarilyunavailable" message, and company officials could not be reachedby phone for comment.
"We are encouraging all health facilities to immediatelycease use of any product produced by NECC," Dr. MadeleineBiondolillo, Massachusetts public health director of safety,told reporters in a conference call from Boston.
A fungus linked to the steroid medication has beenidentified in specimens from five patients, according to theCDC's Dr. Benjamin Park.
'FAIRLY LONG INCUBATION PERIOD'
The Massachusetts Health Department said there were 17,676vials of medication in each of the three lots underinvestigation. They were sent out July through September andhave a shelf life of 180 days.
The CDC said the fungal contamination was detected in theexamination of one of the sealed vials taken at that company.
Patients who received the injections were at risk ofdeveloping fungal meningitis for at least a month after theirlast exposure, Schaffner said.
"There is a fairly long incubation period. ... That hasn'trun out yet for many patients," Schaffner said.
"Over the next few weeks, we are going to see a progressiveaccumulation of cases," he said.
Fungal meningitis is rare and life-threatening, but is notcontagious from person to person. Meningitis can be passed tohumans from steroid medications that weaken the immune system.Symptoms include a sudden onset of fever, headache, stiff neck,nausea, and vomiting, according to the CDC web site.
In addition to the 25 cases so far in Tennessee, one hasbeen reported in North Carolina, two in Florida, four inVirginia, two in Maryland and one in Indiana, according to CDC'sPark.
About 75 facilities could have received the steroid in the23 states. They are California, Connecticut, Florida, Georgia,Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, NorthCarolina, New Hampshire, New Jersey, Nevada, New York, Ohio,Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia,Texas and West Virginia, according to Park.
One facility in Indiana, St. Mary's Health, said on Thursdaythat 560 patients had received the recalled medication. Theyreceived the steroid at the Surgicare Cross Pointe clinic inEvansville, said St. Mary's spokeswoman Laura Forbes.
She said one of the 560 patients had been diagnosed withmeningitis and was in the hospital and 10 to 15 others had beenadvised to seek further medical care.
In Tennessee, the worst-hit state, some patients are "reallycritically ill" and in intensive care units, said Dr. MarionKainer of the state health department. She declined to say howmany were critical.
A compounding pharmacy takes medications frompharmaceuticals manufacturers and makes them into specificdosages and strengths for use by doctors.
The drug ingredients are regulated by the FDA, butcompounders are regulated by state agencies, the industry'strade association said.
The Massachusetts Health Department said there had beenseveral complaints against NECC. Complaints in 2002 and 2003about the processing of medication resulted in an agreement withgovernment agencies in 2006 to correct deficiencies
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.
(Additional reporting by Deena Beasley, Mary Wisniewski andSusan Guyett; Writing by Greg McCune; Editing by CynthiaJohnston and Peter Cooney)
((Greg.mccune@thomsonreuters.com))
Keywords: HEALTH MENINGITIS/