NASHVILLE, Tennessee. Sun Oct 7, 2012 - U.S. health officials on Sunday reported an additional 27 cases in a fungal meningitis outbreak linked to steroid injections that has killed seven people and now infected 91 in nine states.The U.S. Centers for Disease Control and Prevention reported the new total of 91 cases in an update on its website, up from 64 on Saturday. Most of the new cases were reported in Michigan, where the total increased to 20 from eight. Virginia's total increased to 18 from 11.
The widening outbreak has alarmed U.S. health officials and focused attention on regulations of pharmaceutical compounding companies like the one that produced the drugs, the New England Compounding Center Inc in Framingham, Massachusetts.
The company shipped 17,676 vials of the steroid methylprednisolone acetate to 76 facilities in 23 states from July through September, the Massachusetts Health Department said.
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 the brain and spinal cord, and affected patients started showing a variety of symptoms from one to four weeks after their injections.
The company, which was previously the subject of complaints, has suspended its operations while an investigation proceeds and earlier recalled the three lots of the drug. It expanded its recall on Saturday to all products compounded and distributed at its Framingham facility.
According to an announcement on its website, the company issued the broader recall out of "an abundance of caution" because of the "potential risk of contamination."
A compounding pharmacy takes medications from pharmaceuticals manufacturers and makes them into specific dosages and strengths for use by doctors.
Complaints against the company in 2002 and 2003 about the processing of medication resulted in an agreement with government agencies in 2006 to correct deficiencies, the Massachusetts Health Department said.
LIMITED FDA AUTHORITY
In 2011, there was another inspection of the facility and no deficiencies were found. In March 2012, another complaint was made about the potency of a product used in eye surgery procedures. That investigation is continuing, the state health department said.
The U.S. Food and Drug administration has limited authority over the day-to-day operations of compounding pharmacies, which are regulated primarily by state boards that oversee the practices, licensing and certification of pharmacies and pharmacists.
Compounded products do not have to win FDA approval before they are sold, and the agency has no jurisdiction over how the products are manufactured or labeled for use. Instead, the FDA investigates cases of adulterated drugs in cooperation with state regulators.
The FDA has tried to exert greater authority over compounded drug products under a section of the Food, Drug and Cosmetic Act that covers new drugs. But those efforts led to federal court challenges that resulted in two separate and conflicting rulings at the appellate level.
The nine states where fungal meningitis cases have been reported are Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia.
Tennessee, where the outbreak was first detected, accounted for most of the cases, with 32, including three deaths. Many patients there remain hospitalized, some in critical condition.
Michigan had 20 cases and two deaths. One person died in Maryland and another in Virginia, the CDC said.
Reuters had reported 65 cases on Saturday, including one additional case after the CDC published its total.
Fungal meningitis is not contagious, the CDC said. Symptoms include fever, headache, nausea and neurological problems 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, Texas, Virginia and West Virginia, the CDC said.
A list of facilities that received vials from the infected lots can be found via the website cdc.gov.