December 2009
Recalls and Safety Alerts
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| Boxed Warning about Tissue Injury with IV Promethazine |
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FDA is requiring that promethazine
hydrochloride injection products carry a boxed warning to communicate
more strongly about the danger of giving the drug intravenously. The
warning states that intra-arterial and subcutaneous administration of
promethazine are contraindicated.
Promethazine is used as an
antihistamine, a sedative and an antiemetic. Giving promethazine
intravenously can result in severe tissue injury, including gangrene,
which may require amputation. Because of this risk, the preferred route
of administration is deep intramuscular injection.
If IV
administration of promethazine is required, a maximum concentration of
25 mg/mL should be administered at a maximum rate of 25 mg/minute,
through the tubing of an infusion set known to be functioning properly.
The 50 mg/mL concentration should be used only for deep intramuscular
injection.
Healthcare professionals should be alert to signs and
symptoms of potential tissue injury, such as burning or pain at the
administration site, phlebitis, swelling, and blistering. They should
stop giving the drug immediately if a patient complains of pain. They
should also tell patients receiving IV promethazine that side effects
may occur immediately or develop hours to days after administration of
the drug.
Additional Information:
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| Philips HeartStart AEDs Recalled |
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Philips Healthcare is recalling certain
HeartStart FR2+ automated external defibrillators. These AEDs are used
by hospitals, fire departments and emergency medical services to treat
sudden cardiac arrest. The recalled devices may have a memory chip
failure that could make them inoperable and prevent therapy from being
delivered.
The recall covers two models distributed by
Philips, the M3860A and the M3861A, and two models distributed by
Laerdal Medical, the M3840A and the M3841A. All were manufactured
between May 2007 and January 2008. Philips is contacting customers to
arrange for the return and replacement of the recalled AEDs.
Additional Information:
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| Certain Unomedical Pulmonary Resuscitators Recalled |
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The device company Unomedical Inc. is
recalling some of its manual pulmonary resuscitators. A malfunction of
these devices may make it difficult to generate enough positive
pressure to resuscitate a patient properly, and that could lead to
serious adverse health consequences or death.
The recall
affects certain lots of resuscitators manufactured between July 2002
and March 2008. If a unit has already been removed from its packaging,
healthcare professionals can determine whether it is a recalled unit by
looking at the retention ring located immediately below the exhalation
port within the clear plastic housing. The recalled units have a clear
or transparent retention ring, or have no visible retention ring. Units
that are not being recalled have a clearly visible blue retention ring,
and don't need to be returned.
Unomedical is contacting its
distributors and customers to arrange for the return and credit of the
recalled resuscitators. For more information, contact Unomedical at
1-800-634-6003.
Additional Information:
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| Important Changes for Heparin |
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FDA is notifying healthcare
professionals and patients about a new USP monograph for heparin. Under
the new monograph, the reference standard used to determine the potency
of the drug will be changed in order to make it compatible with the WHO
International Standard. Despite these changes in the reference
standard, heparin dosages will continue to be expressed in USP units.
Partly in response to the recent heparin contamination problem, the new
monograph also includes additional test methods that can detect
potential impurities and contaminants.
As a result of the change
in the reference standard, the potency of heparin marketed in the U.S.
will now be reduced by about 10 percent, so, there could be up to a 10
percent decrease in heparin activity for each USP unit administered.
This means that some patients may require more heparin to achieve and
maintain the desired level of anticoagulation. Patients may also
require more frequent or intensive monitoring of aPTT or ACT.
This
could be especially significant in some situations - for example, when
heparin is administered as a bolus IV dose and it is important to
achieve an immediate anticoagulant effect. The changes in heparin
potency may not be clinically significant when it is given
subcutaneously, because the drug's bioavailability is lower and more
variable when it's administered this way.
Manufacturers began
shipping the new heparin product in early October. For a while, both
products will be available at the same time, to assure that there is an
adequate supply for all patients. FDA has asked the manufacturers to
label their heparin to differentiate between the old and new
formulations.
FDA is working with heparin manufacturers to
study the possible impact of reduced heparin potency on clinical care,
and will share the results of these studies when they are available.
Additional Information:
| Medtronic Sutureless Connector Catheters Incompatible with IsoMed Pumps |
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Medtronic Neuromodulation is alerting
healthcare professionals and patients that the company's Sutureless
Connector (SC) catheters and revision kits are not compatible with
IsoMed implantable infusion pumps.
The product labeling
incorrectly stated that SC catheters were compatible with IsoMed pumps.
This was corrected in an August 2009 letter to healthcare
professionals. The letter explained that SC catheters are not
compatible with IsoMed pumps because the catheter may not connect
completely to the pump, even if it appears to be securely connected. If
that happens, the catheter may become disconnected from the pump, or an
occlusion may occur at the connection site. This could result in tissue
damage if a drug or cerebrospinal fluid leaks into surrounding tissue.
Patients could also experience a loss of or change in therapy, a return
of underlying symptoms or a serious or even fatal drug underdose.
Medtronic's
letter cautions that the SC catheters are compatible with Medtronic
SynchroMed II and SynchroMed EL pumps, but once an SC catheter has been
connected to an IsoMed pump, the catheter connector may be permanently
damaged, which could then prevent the catheter from connecting properly
to a SynchroMed pump.
Here are the company's recommendations:
•
For future revisions and implants, do not use SC catheters with IsoMed
pumps. Also, do not connect a SC catheter that was previously connected
to an IsoMed pump to a SynchroMed pump because the catheter connector
may have been permanently damaged.
• If an SC catheter is, or
has been, connected to a patient's IsoMed pump, use clinical judgment
to decide if prophylactic revision is warranted.
• If a
disconnection or occlusion occurs, revision will be necessary. Note
that patients who have had their therapy interrupted for any reason may
be effectively drug naive at the time they undergo revision. And so
they may be at risk for drug overdose after their revision surgery. So
practitioners should follow the initial dosing and patient monitoring
recommendations in the drug labeling.
• Continue to educate
patients and caregivers to recognize the signs and symptoms of drug
underdose and withdrawal, and to seek medical help immediately if they
occur.
Additional Information:
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| Radiation Overdoses from CT Scans |
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FDA is investigating a situation in
which more than 200 patients undergoing CT brain perfusion scans at a
single hospital received overdoses of radiation. In some cases the
radiation doses were high enough to produce erythema and hair loss.
While
these events involved one type of procedure at one facility, FDA is
concerned that they could reflect more widespread problems with CT
quality assurance programs. If patient doses from CT procedures were
higher than the expected level but not high enough to produce obvious
signs of radiation injury, the problem could go undetected and
unreported. This could put patients at increased risk for long-term
radiation effects, including certain types of cancer.
To help
prevent overexposures, FDA is encouraging facilities that perform CT
procedures to be aware of the dose indices displayed on the control
panel. These indices include the volume CT dose index, expressed
"milligray" (mGy), and the dose-length product, expressed in
"milligray-centimeter" (mGy-cm). Before a patient is scanned, the
operator should make sure that the values displayed for these indices
correspond reasonably to those normally associated with the procedure
being performed. These indices should be checked again after the
patient is scanned.
FDA is working to obtain more information on
reports of CT overdoses and encourage healthcare professionals to
report these when they occur.