FDA Patient Safety News: Show #48, February 2006

First Donor Screening Test for West Nile Virus

FDA recently approved the first test to screen blood donors for the West Nile virus. The test, called the Procleix WNV Assay, can also be used to screen donors of organs, cells and tissues. The test was developed by Gen-Probe Inc., and will be marketed by Chiron. It tests blood samples from donors of blood, tissue and organs for the presence of the virus.

Although West Nile infection is primarily a mosquito-borne disease, there have been about 30 documented cases where people most likely acquired the infection from a blood transfusion, and nine of them died. Most people infected with the virus don't have symptoms and aren't aware of their infection, so they might unknowingly try to donate blood. This test can help to protect patients who receive blood and other products against West Nile infection.

Additional Information:

FDA Press Release - FDA Approves First Test to Screen for West Nile Virus in Donors of Blood, Organs, Cells and Tissues.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108523.htm


First Donor Screening Test for West Nile Virus

FDA recently approved the first test to screen blood donors for the West Nile virus. The test, called the Procleix WNV Assay, can also be used to screen donors of organs, cells and tissues. The test was developed by Gen-Probe Inc., and will be marketed by Chiron. It tests blood samples from donors of blood, tissue and organs for the presence of the virus.

Although West Nile infection is primarily a mosquito-borne disease, there have been about 30 documented cases where people most likely acquired the infection from a blood transfusion, and nine of them died. Most people infected with the virus don't have symptoms and aren't aware of their infection, so they might unknowingly try to donate blood. This test can help to protect patients who receive blood and other products against West Nile infection.

Additional Information:

FDA West Nile Virus Information.
http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118577.htm


First Donor Screening Test for West Nile Virus

FDA recently approved the first test to screen blood donors for the West Nile virus. The test, called the Procleix WNV Assay, can also be used to screen donors of organs, cells and tissues. The test was developed by Gen-Probe Inc., and will be marketed by Chiron. It tests blood samples from donors of blood, tissue and organs for the presence of the virus.

Although West Nile infection is primarily a mosquito-borne disease, there have been about 30 documented cases where people most likely acquired the infection from a blood transfusion, and nine of them died. Most people infected with the virus don't have symptoms and aren't aware of their infection, so they might unknowingly try to donate blood. This test can help to protect patients who receive blood and other products against West Nile infection.

Additional Information:

Product Approval Information - Licensing Action.
http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm090365.pdf


Preventing Hemolysis with Meridian Hemodialysis Blood Tubing

Baxter Healthcare has alerted dialysis clinics about cases of hemolysis occurring in patients being treated with the company's Meridian Hemodialysis Instrument. The hemolysis was caused by kinking in the blood tubing sets used with the Meridian units. One patient died and at least one other patient sustained serious injury.

The front of the Meridian instrument has a clip that has two channels. The original device labeling instructed users to route the blood tubing through both of these channels. But doing that increases the risk that the tube will kink.

The company advised users to route the tubing through only one of these channels and also to continuously inspect the tubing to be sure that it isn't kinked. In addition, the notification includes diagrams and labels that display the right way to use the clips. You should attach these labels to the front of the instrument.

The affected devices are all Meridian Instruments with model numbers 5M5576 and 5M5576R. Baxter will be providing users with modified tubing clips to correct the problem. For additional information, you can contact Baxter at 1-800-4BAXTER.

Additional Information:

FDA MedWatch Safety Alert 2005 - Baxter Meridian Hemodialyis (HD) Instrument.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152887.htm


Bacterial Contamination of Vapotherm Devices

FDA issued updated information about an association between the Vapotherm 2000i device and the occurrence of positive Ralstonia cultures. Ralstonia are gram-negative bacteria that were formerly included in the genus Pseudomonas or Burkholderia. The Vapotherm device is used to add moisture and warm breathing gases through a nasal cannula in patients receiving supplemental oxygen.

Reports to FDA and CDC from hospitals in 16 states indicate that some Vapotherm devices are colonized by Ralstonia, and the bacteria have also been isolated from patients exposed to these devices. FDA is continuing to work with CDC to determine the source and scope of the Ralstonia contamination, find out whether other organisms may be involved, and evaluate disinfection protocols.

FDA is advising clinicians and institutions to use alternative devices until the source of contamination has been identified. FDA is also advising that patients who've been exposed to the Vapotherm system be monitored for signs and symptoms of infection. These can include changes in temperature, poor feeding, irritability, and blood count changes. Clinicians may want to consider Ralstonia infection in symptomatic patients who've been exposed to a Vapotherm device even if the organism has not been isolated.

UPDATE: On January 25, 2006, Vapotherm Inc. issued a press release stating that any health care facilities that have the Vapotherm 2000i device must return all devices to the company.

Additional Information:

FDA Preliminary Public Health Notification: Update of Information about Ralstonia spp. Associated with Vapotherm® Respiratory Gas Administration Device. (Includes finding alternative devices).
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm064407.htm


Bacterial Contamination of Vapotherm Devices

FDA issued updated information about an association between the Vapotherm 2000i device and the occurrence of positive Ralstonia cultures. Ralstonia are gram-negative bacteria that were formerly included in the genus Pseudomonas or Burkholderia. The Vapotherm device is used to add moisture and warm breathing gases through a nasal cannula in patients receiving supplemental oxygen.

Reports to FDA and CDC from hospitals in 16 states indicate that some Vapotherm devices are colonized by Ralstonia, and the bacteria have also been isolated from patients exposed to these devices. FDA is continuing to work with CDC to determine the source and scope of the Ralstonia contamination, find out whether other organisms may be involved, and evaluate disinfection protocols.

FDA is advising clinicians and institutions to use alternative devices until the source of contamination has been identified. FDA is also advising that patients who've been exposed to the Vapotherm system be monitored for signs and symptoms of infection. These can include changes in temperature, poor feeding, irritability, and blood count changes. Clinicians may want to consider Ralstonia infection in symptomatic patients who've been exposed to a Vapotherm device even if the organism has not been isolated.

UPDATE: On January 25, 2006, Vapotherm Inc. issued a press release stating that any health care facilities that have the Vapotherm 2000i device must return all devices to the company.

Additional Information:

Vapotherm ISSUES URGENT NATIONWIDE RECALL OF All Vapotherm® 2000i Respiratory Gas Humidification Devices – Company Press Release.
http://www.fda.gov/oc/po/firmrecalls/Vapotherm2000i_01_06.html


Avoiding Glucose Monitoring Errors in Patients Receiving Other Sugars

FDA issued a reminder about the potential for falsely elevated glucose readings in patients who are also receiving products that contain other sugars. These products include oral xylose, parenterals that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin.

A patient recently died because of this problem. His glucose readings were very high, so he was given aggressive insulin treatment. The glucose readings were falsely high, however, and too much insulin was administered. The patient suffered irreversible brain damage and died.

In this case the glucose meter was reading the patient’s actual blood glucose level, plus the maltose that was contained in the IV immune globulin he was receiving. The readings were falsely elevated because the glucose monitoring device couldn't distinguish between glucose and other sugars.

All glucose meters don't suffer from this problem. There are four kinds of enzymatic glucose monitoring methods that are used, and only one of those has this problem. This problem occurs only with the monitoring method that uses an enzyme called GDH-PQQ. This method is employed in some glucose monitoring devices used by diabetics at home and in point-of-care settings.

The other three test methods currently used in glucose monitoring systems are called GDH-NAD, glucose oxidase, and glucose hexokinase, and they are capable of distinguishing between glucose and other sugars.

The test method used in glucose meters is identified in the package insert that comes with the glucose test strips. The package insert is also available from the manufacturer. The most important thing to remember is not to use the GDH-PQQ method if the patient recently received other sugars. That includes oral xylose for a D-Xylose absorption test, or an IV solution containing maltose or galactose, or a peritoneal dialysis solution containing icodextrin.

Additional Information:

FDA MedWatch Safety Alert 2005 - Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150453.htm


Recall of Boston Scientific Vena Cava Filters

Boston Scientific is recalling certain vena cava filter systems. The recalled devices are small cone-shaped filters used to help prevent pulmonary embolism. The filters are implanted in the inferior vena cava to capture blood clots before they're carried to the lungs.

The devices are being recalled because in a small number of cases, a certain
part of the filter's delivery system has become detached while the device was being implanted. This has led to reports of patient injuries and one patient death. This recall applies only to devices that have not yet been implanted in patients.

The recall affects the Stainless Steel Greenfield® Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. These devices have a "use before" date of March 2007. For instructions on how to return any unused devices covered by this recall, contact Boston Scientific at 888-272-1001.

Additional Information:

Recall – Firm Press Release.
http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2005/ucm111921.htm


Alpha-1 Blockers and Cataract Surgery Procedures

Boehringer Ingelheim notified healthcare professionals that a surgical condition called Intraoperative Floppy Iris Syndrome has been observed during phacoemulsification cataract surgery in some patients taking alpha-1 blockers such as Flomax (tamsulosin HCI). These drugs are used to treat benign prostatic hyperplasia and hypertension. Most cases occurred in patients who were taking alpha-1 blockers at the time of the eye surgery, but in some cases the drug had been stopped prior to surgery.

Health care practitioners should ask patients considering cataract surgery about whether they've taken Flomax or other alpha-1 blockers. If so, the ophthalmologist performing the procedure should be informed so that the surgical technique can be modified if necessary.

Additional Information:

FDA MedWatch Safety Alert - Flomax (tamsulosin HCl).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151211.htm


Amevive Contraindicated in HIV Patients

Biogen Idec notified healthcare professionals that the drug Amevive (alefacept) which is used to treat severe chronic plaque psoriasis, is contraindicated in patients infected with HIV. Amevive reduces CD4+ T lymphocytes, which might accelerate HIV progression or increase complications.

Additional Information:

FDA MedWatch Safety Alert 2005 - Amevive (alefacept).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150623.htm


Reporting Adverse Events for Drugs, Devices, Biologics and Dietary Supplements

An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they suspect are 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 example of the antibiotic Zyvox. Within the first six months of Zyvox's marketing, FDA began getting MedWatch reports of myelosupression from clinicians who suspected that the drug might be responsible. After investigating the problem, FDA worked with the manufacturer to change the Zyvox labeling to warn about the potential for myelosuppression.

Sometimes MedWatch reports highlight errors in prescribing or administering medications. For example, FDA received reports of patient injuries due to name confusion between LANOXIN, a heart medication, and what used to be called LEVOXINE, a thyroid medication. As a result, FDA asked the manufacturer to change the name of Levoxine, and now it's known as LEVOXYL, which is less likely to be confused with LANOXIN.

The MedWatch system can also help detect problems with medical products other than drugs. For example, FDA received two reports of pneumococcal eye infections in patients who'd received corneal transplants. An FDA inspection identified numerous manufacturing problems, which led the company to recall the implants.

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

It's important to keep the MedWatch system working, and FDA needs your help. Here are the kinds of reports that should be submitted:

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

Report therapeutic failures - cases in which 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).

Report cases of use errors with medications or devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.

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

FDA encourages reporting these problems to MedWatch even if you're not sure that the product was the cause. It's easy to report by internet, phone, fax, or mail.

Additional Information:

MedWatch - The FDA Safety Information and Adverse Event Reporting System.
http://www.fda.gov/medwatch/


Drug Name Confusion: Salagen and Selegiline

The Institute for Safe Medication Practices recently described several cases where the brand name of one drug was mistaken for the generic name of another. Salagen, a brand name for pilocarpine, is used to treat the dry mouth symptoms caused by Sjogren's syndrome or radiation therapy. Selegiline is an MAO-inhibitor used to treat Parkinson's disease. Both drugs are available in 5 mg tablets.

In the first case, the mix-up occurred because the names sounded alike. A home health nurse received a telephone order from a dentist for an elderly patient with problems related to a dry mouth. The dentist prescribed Salagen 5 mg, but the nurse misheard the order and called the pharmacy to request selegiline 5 mg. About 2 weeks later, another pharmacist was processing a prescription for a fentanyl patch for the same patient when the pharmacy computer system signaled an alert about a drug interaction between fentanyl and selegiline. When the pharmacist contacted the prescriber, he discovered the error.

In the second case, a pharmacist reported that the similar spelling of the two drug names led him to enter "selegiline" into the computer instead of "Salagen". The error was recognized only after the patient complained that the medication was not helping his dry mouth, and this caused the pharmacist to check the patient's profile.

In order to minimize these kinds of mix-ups, ISMP says to list both the brand and generic names on prescriptions. And patients who use these drugs regularly should be alerted to report any change in the appearance of their medications.

Additional Information:

ISMP Medication Safety Alert - Look-and Sound-Alike Names. September 2005.
http://www.ismp.org/newsletters/acutecare/articles/20050922_1.asp



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