Because of concern about possible contamination of additional
medications, the FDA is requesting that health providers contact
patients who meet all the following criteria:
-
The medication was
shipped by NECC on or after May 21.
-
The medication was
any injectable product purchased from or produced by NECC,
including an ophthalmic drug that is injectable or used in
conjunction with eye surgery, or a cardioplegic solution.
-
The medication was administered to
patients on or after May 21.
"The Illinois Department of Public Health wants to make sure
health providers in Illinois are aware of the new FDA directive
requesting them to contact patients who received specified
medications from the New England Compounding Center on or after May
21, 2012," said Dr. LaMar Hasbrouck, director of the Illinois
Department of Public Health Director. "Physicians should conduct a
thorough evaluation of patients who report symptoms of infection
following exposure to one of these NECC products."
For medications used in the eye, symptoms could include vision
change, increased redness or drainage. Symptoms of meningitis
include fever, headache, stiff neck, nausea and vomiting,
sensitivity to light, and altered mental status. Symptoms for other
possible infections may include fever; swelling, increasing pain,
redness and warmth at the injection site; chest pain; or drainage
from the surgical site.
IDPH and FDA do not urge patient follow-up at this time for NECC
products of lower risk such as topicals (lotions, creams, eyedrops
not used in conjunction with surgery) and suppositories, or for
patients who may have received an NECC product before May 21.
The FDA and the Centers for Disease Control and Prevention
continue to investigate the multistate outbreak of fungal infections
among patients who received a steroid injection with a potentially
contaminated product, methylprednisolone acetate, produced by NECC.
As of Monday, the CDC reported 297 cases in 16 states, including 23
deaths. Patients who received implicated lots of methylprednisolone
acetate have already been notified.
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IDPH is continuing to report one probable case -- a Chicago
resident who received an epidural steroid injection from one of
three implicated lots of methylprednisolone acetate originally
recalled by NECC. The person received the injection at one of the
three APAC Centers for Pain Management that received the recalled
medication. The person received the injection during the exposure
period set by the Centers for Disease Control and Prevention -- May
21-Sept. 26 -- and continues to undergo further testing and
treatment.
The FDA has posted facility and product information provided by
NECC on its website at
http://www.fda.gov/Drugs/DrugSafety/
ucm323431.htm. Facilities should determine what NECC drugs meet
the specified criteria and contact patients accordingly.
To date, there have been no confirmed reports of infections
definitively linked to other products produced by NECC. However, out
of an abundance of caution, the FDA and IDPH are recommending the
additional notifications.
The Illinois Department of Financial and Professional Regulation
has suspended NECC's pharmacy license. This action follows the
voluntary surrender of NECC's license in several states, including
Massachusetts. The license suspension is effective immediately and
will stay in place indefinitely. If NECC seeks to restore its
license in Illinois, it will have to meet stringent requirements
outlined in a consent agreement.
For more information on the meningitis outbreak, see
http://www.cdc.gov/hai/outbreaks/meningitis.html.
[Text from
Illinois
Department of Public Health file received from
the
Illinois Office of
Communication and Information] |
