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U.S. Department of Health and Human Services

Show #93, December 2009

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Show #93, December 2009

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 Recalls and Safety Alerts

December2009FDA Patient Safety News Homepage
Boxed Warning about Tissue Injury with IV Promethazine (Video, print, and e-mail functions)
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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.

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December2009FDA Patient Safety News Homepage
Philips HeartStart AEDs Recalled (Video, print, and e-mail functions)
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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.

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December2009FDA Patient Safety News Homepage
Certain Unomedical Pulmonary Resuscitators Recalled (Video, print, and e-mail functions)
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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.

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December2009FDA Patient Safety News Homepage
Important Changes for Heparin (Video, print, and e-mail functions)
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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.

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December2009FDA Patient Safety News Homepage
Medtronic Sutureless Connector Catheters Incompatible with IsoMed Pumps (Video, print, and e-mail functions)
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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.

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December2009FDA Patient Safety News Homepage
Radiation Overdoses from CT Scans (Video, print, and e-mail functions)
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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.

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December2009FDA Patient Safety News Homepage
Reporting Adverse Events to FDA’s MedWatch (Video, print, and e-mail functions)
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An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.

Take the case where over 100,000 vials of the long-acting insulin Levemir were stolen and may not have been stored or handled properly. That could have made it dangerous for patients to use. After learning about a diabetic patient who suffered a serious side effect from poor blood glucose control, FDA and the drug's manufacturer were able to determine that the stolen Levemir was being sold, and to warn the public not to use it.

Even one report can make a difference. For example, a family member of an MS patient sent FDA a report about the patient suffering heart failure after being treated with a relatively low dose of Novantrone. This led FDA to further investigate the potential for cardiotoxicity from lower doses of Novantrone, and that resulted in updated recommendations for closer monitoring of cardiac function in patients being treated with the drug.

Reporting can also help detect problems with medical products other than drugs. For example, FDA received several reports stating that a company's drug-eluting coronary stents had been implanted in patients who were supposed to receive that company's bare metal stents, and vice-versa. The two stents shared part of a trade name - Liberte - and that contributed to the potential for confusion.
FDA then worked with the company, which changed the name of the bare metal stent from Liberte to VeriFLEX in order to better distinguish the two products.

Of course, MedWatch reports alone rarely confirm a causal relationship between an adverse event and a medical product. It may take a formal epidemiologic study or a controlled clinical trial to do that. Still, MedWatch reports are vital in helping to make sure that medical products are safe, because they provide a rapid signal to FDA that problems may be occurring.

It is important to keep the MedWatch system working, and FDA cannot do that without your help. Here are the kinds of reports we need from you:

• Serious adverse event that might be associated with a drug, biologic, medical device, dietary supplement or cosmetic product. We're particularly interested in serious adverse events that are not listed in the product labeling. "Serious" means fatalities, hospitalizations, and medically significant events.

• Therapeutic failures --- cases where the drug or device failed to work as it should (e.g., if a patient has to switch from one brand of a drug to another because the original one was ineffective).

• Use errors with medications or devices. That includes situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.

• Product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.

Report these problems to MedWatch even if you are not sure that the product was the cause. You can find information about how to report at the "Additional Information" link below.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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