* FDA eye different steroid, heart drug for meningitis link
* CDC says more than 200 people infected so far
* Company faces multiple investigations
* Couple files first Tennessee lawsuit against NECC
(Adds NECC statement, victim lawsuit, Sen. Blumenthal comment)
CHICAGO/NEW YORK, Oct 15 (Reuters) - Two other drugs made by
the Massachusetts pharmacy at the center of a deadly meningitis
outbreak may be linked to the disease, U.S. health regulators
said on Monday, potentially widening the scope of the health
crisis.
The Food and Drug Administration said it was looking into
reports of a patient with possible meningitis who received an
injection of a different steroid than the one found to have
caused 15 deaths. It also said two transplant patients were
infected with the rare fungus linked to the meningitis outbreak
after receiving a heart drug also made by the New England
Compounding Center (NECC) of Framingham, Massachusetts.
Nine more people have been diagnosed with fungal meningitis
linked to possibly tainted vials of the injected steroid
methylprednisolone, bringing the number of cases to 212,
according to the U.S. Centers for Disease Control and Prevention
(CDC). A Tennessee woman among these cases filed a lawsuit on
Monday against NECC seeking $15 million in damages.
The patient identified by the FDA as potentially having
meningitis received an injection for pain of the steroid
triamcinolone, also supplied by NECC.
The FDA said its investigation of that patient and the two
who received the heart drug during surgery was ongoing, and it
cautioned that any injectable drugs made by NECC, including
those intended for use in eyes, are of "significant concern."
The FDA has not confirmed that these three infections were
caused by NECC products.
NECC said in a statement that it was reviewing the new
information from the FDA. "We continue to cooperate with the
FDA, as we are with the CDC and the Board of Registration in
Pharmacy of the Massachusetts Department of Public Health," it
said.
The meningitis outbreak expanded to 15 states on Monday as
Pennsylvania reported its first case.
The Pennsylvania patient, who received the epidural steroid
injection in July, was being treated in a hospital, the
Pennsylvania Department of Health said.
The nine new cases include the one in Pennsylvania, five in
Michigan, two in Ohio, and one in Minnesota.
TENNESSEE SUSPENDS NECC LICENSE
All but eight of the 23 states that received suspect
medications from the Massachusetts specialist pharmacy have
reported at least one case of fungal meningitis, a rare and
deadly disease that has proven difficult to treat.
The suspect lots of steroid were shipped to 76 facilities in
23 states, including two locations in Pennsylvania.
"We have been working directly with the clinics to ensure
that patients who received these injections are monitored and
receive any necessary follow-up," said Acting Pennsylvania
Secretary of Health Michael Wolf.
Health authorities have said that nearly 14,000 people
nationwide have received injections from the potentially
contaminated medication originally linked to the outbreak.
Tennessee, the state worst affected with 53 cases and six
deaths, suspended NECC's license there on Monday. NECC had
already surrendered its license to operate in Massachusetts and
halted operations. It also recalled all of its products,
including three lots of steroid that tested positive for fungus
contamination.
A list of recalled NECC products on the FDA website ran 70
pages long. http://www.fda.gov/Safety/Recalls/ucm322979.htm
It contained drugs for dozens of therapeutic categories,
including pain medicines, antibiotics, eye drugs, hair restorers
and skin care products.
At St. Thomas hospital in Nashville, Tennessee, more than
275 people have undergone spinal tap tests, a painful procedure
to determine if they have meningitis. Thirty-three of them were
infected.
In Tennessee's first lawsuit against NECC, Janet Russell,
71, claimed she contracted fungal meningitis after receiving one
injection of methylprednisolone for back pain on Aug. 30 at St.
Thomas' Outpatient Neurosurgery Center.
The lawsuit claims that as a result, she suffers pain, the
effects of a stroke, permanent disability, and emotional
distress and will need ongoing medical treatment. Her husband of
53 years filed the lawsuit with her on Monday.
She is currently in the hospital's intensive care unit, her
attorney said.
NECC is being investigated by federal and state authorities.
Pharmacy company Ameridose, which shares common ownership with
NECC, has suspended operations.
Meningitis is an infection of the membranes covering the
brain and spinal cord. Symptoms include headache, fever and
nausea. Fungal meningitis is not contagious.
The outbreak has raised questions about how the
pharmaceuticals industry operates. NECC engaged in a practice
called drug compounding that is not regulated by the FDA, which
generally oversees drug makers.
In compounding, pharmacies prepare specific doses of
approved medications, based on guidance from a doctor, to meet
an individual patient's need.
A Reuters investigation found that NECC solicited bulk
orders from physicians and failed to require proof of individual
patient prescriptions as required under state regulations,
emails to a customer showed.
State pharmacy regulators have said that NECC violated its
license in Massachusetts by not requiring patient prescriptions
before shipping products.
U.S. Senator Richard Blumenthal of Connecticut called for an
immediate criminal investigation of NECC and its officers and
employees. "The scope of this disaster, which only increases by
the day, is a call to action for increased federal oversight of
these unauthorized drug manufacturers masquerading as
compounding pharmacies," he said in a statement.
Several states, including Michigan, Massachusetts, Indiana,
Minnesota and Ohio, are investigating the company.
The 15 states reporting cases of meningitis are Tennessee,
Michigan, Pennsylvania, New Hampshire, Illinois, Indiana,
Minnesota, New Jersey, Texas, Idaho, Maryland, North Carolina,
Virginia, Ohio and Florida.
(Additional reporting by Michele Gershberg in New York and
David Morgan in Washington; Editing by Vicki Allen)
