* Most news cases in Michigan
* Thousands of patients may have received injections
* Pharmaceutical company broadens recall of products
NASHVILLE, Tenn., Oct 7 (Reuters) - 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.
