Tighter US drug rules urged as fungal meningitis deaths rise



BY TIM GHIANNI, REUTERS 
The United States is home to some 3,166,529 Filipinos, based on the 2010 Stock Estimate of the Commission on Filipinos Overseas. 

NASHVILLE, Tenn. - A rare U.S. outbreak of fungal meningitis linked to steroid injections has claimed three more lives and New Jersey became the tenth state to report at least one case of the illness in a widening health scare, authorities said on Tuesday.
 
The Centers for Disease Control and Prevention confirmed that two more people had died from meningitis in Tennessee, and one more in Michigan after receiving steroid injections, bringing the number of deaths nationwide to 11.
 
The widening outbreak has alarmed U.S. health officials and focused attention on regulation of pharmaceutical compounding companies such as the one that produced the drugs, the New England Compounding Center Inc in Framingham, Massachusetts.
 
Some leading Democratic members of Congress on Tuesday proposed tighter regulation on compounding companies.
 
In Michigan and Tennessee, the two states hit hardest by the outbreak, family and friends mourned the loss of victims.
 
George Cary attended a memorial on Tuesday for his British-born wife of 35 years, Lilian, who died of meningitis on Sept. 30 several weeks after receiving an injection for back pain. Standing with his two daughters at their house in Howell, Michigan, Cary said that he now would await the results of a test for meningitis after he also received an injection.
 
"I'm fine right now. I'm waiting to see if anything develops," Cary said.
 
Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea. Fungal meningitis, unlike viral and bacterial meningitis, is not contagious.
 
One of the dead in Tennessee, 80-year-old Reba Temple, was a former health director for rural Hickman County.
 
"She was a wonderful, wonderful lady," said County Trustee Cheryl Chessor, who attended the same church as Temple, Centerville Church of Christ.
 
Incubation period
 
The number of people sickened nationwide reached 119 on Tuesday, an increase of 14 cases from Monday.
 
The potentially tainted steroid vials, which have been recalled, were shipped to 76 facilities in 23 states and some 13,000 people may have received injections from the medications, the CDC has said.
 
Tennessee Health Commissioner Dr. John Dreyzehner said it could be early November before all the patients stricken with meningitis are identified.
 
This is because the incubation period may be longer than the one month health experts first thought. Of the patients who contracted meningitis in Tennessee, the latest case was reported 42 days after the injection, he said on Tuesday.
 
In Tennessee, Saint Thomas Outpatient Neurosurgery Center in Nashville received 2,000 vials of recalled steroid, the most of any facility in the nation.
 
The New Jersey Department of Health said a 70-year-old Cumberland County man was hospitalized with apparent fungal meningitis, the first case in that state.
 
"He developed headaches and went to the emergency room with fever and continued headaches," the New Jersey agency said, adding that he was receiving anti-fungal medication at South Jersey Healthcare Regional Medical Center in Vineland.
 
Stricter regulation
 
The federal Food and Drug Administration regulates only the ingredients and not the compounders, which are subject to a patchwork of state oversight.
 
Three Democratic members of the U.S. House of Representatives called on Tuesday for a congressional probe of the meningitis outbreak.
 
A fourth Democrat, Representative Edward Markey, whose Massachusetts district includes Framingham, said separately that he would introduce legislation to strengthen FDA's regulatory authority.
 
But the office of the Republican chairman of the committee that would consider Markey's proposal, Fred Upton, did not respond to requests seeking comment.
 
"This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws," the Democrats Henry Waxman, Frank Pallone and Diana DeGette said in a letter.
 
Tennessee has reported six deaths and 39 cases of meningitis, followed by Michigan with three deaths and 25 cases, Virginia with one death and 24 cases and Maryland with one death and eight cases.
 
The other states with cases are Indiana (12), Florida (4), Minnesota (3), North Carolina (2), Ohio (1) and New Jersey (1). - Reuters

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