* U.S. authorities widen tainted drug investigation
* Cases reported in 15 states
NEW YORK Oct 16 The U.S. meningitis outbreak
that has so far killed 15 people and sickened more than 200
others is "nowhere near the end," a top medical expert said
Tuesday, a day after federal authorities warned more tainted
drugs may be linked to the health crisis.
Dr. William Schaffner, an infectious diseases expert at the
Vanderbilt University Medical Center in Nashville, said on "CBS
This Morning" that he expects a "steady increase" in the number
of fungal meningitis infections over the coming weeks.
The move on Monday by the Food and Drug Administration to
widen its investigation into the cause of the fungal meningitis
outbreak to other drugs made by a Massachusetts pharmacy, the
New England Compounding Center (NECC), is "ominous," Schaffner
"We were concerned that there might be other medications
that might be contaminated coming from that pharmacy," said
Schaffner, who is past-president of National Foundation for
Infectious Disease. "The FDA has given us a heads up that that
looks to be the case. We'll have to notify many more patients
across the country that they may have been exposed to a fungal
"I think we're still in the middle," Schaffner said, when
asked about the outbreak's scope. "We're nowhere near the end of
this problem. And we will see more patients reporting in ill and
we'll have to treat many more going forward."
The FDA said Monday it was looking into two other drugs made
by NECC, based outside of Boston in Framingham, Massachusetts.
The agency said it had received 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 NECC.
Also on Monday, the Centers for Disease Control and
Prevention said nine more people were diagnosed with fungal
meningitis linked to possibly tainted vials of the injected
steroid methylprednisolone, bringing the number of cases to 212.
The patient identified by the FDA as potentially having
meningitis received an injection 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 in a statement said it was
reviewing the new information from the FDA.
On Monday a Tennessee woman filed a lawsuit against NECC
seeking $15 million in damages.
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.
A list of recalled NECC products on the FDA website ran 70
pages long. here
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.
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.
(Writing by Dan Burns; Reporting by Susan Heavey; Editing by