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U.S. Department of Health and Human Services

Show #47, January 2006

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Show #47, January 2006

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 Recalls and Safety Alerts

January2006FDA Patient Safety News Homepage
Advisory on Long-Acting Bronchodilators (Video, print, and e-mail functions)
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FDA is notifying health care professionals and asthma patients about long-acting bronchodilators containing beta 2-adrenergic agonists. These agents may increase the risk of severe asthma exacerbations and asthma-related deaths. These products include Advair Diskus, Serevent Diskus, and Foradil Aerolizer.

The manufacturers of these products have been asked to update their existing product labels with new warnings and provide a Patient Medication Guide that describes these risks.

Long-acting beta 2-adrenergic agonists can help asthma patients, but they can also increase the risk of severe asthma exacerbations. In one study, asthma patients who took a long-acting beta agonist along with their usual asthma care had more asthma-related deaths than a similar group who didn't take the beta agonist, although the number of asthma deaths was small.

Because these agents can increase the chance of a severe asthma episode, they should not be the first drug prescribed to treat a patient's asthma. They should only be used for patients who haven't responded to other medications, such as inhaled corticosteroids.

These products are indicated for chronic treatment of asthma, and not to treat the acute symptoms. That’s why it's important for practitioners to advise patients that if their bronchospasms worsen, they should not use long-acting beta agonists, and that they should seek medical treatment immediately.

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January2006FDA Patient Safety News Homepage
Alert on Certain Abbott Diabetes Care Blood Glucose Meters (Video, print, and e-mail functions)
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Abbott Diabetes Care is warning about problems with some of the company’s blood glucose meters. These meters could accidentally be switched from one measurement unit to another, possibly causing the patient to misinterpret the glucose test results. The affected glucose meters include the FreeStyle®, FreeStyle Flash™, FreeStyle Tracker™, Precision Xtra™, MediSense® Sof-Tact™, and MediSense® Optium™. Abbott meters are also sold under private label brands such as ReliOn® Ultima, Rite Aid® and Kroger®.

These meters were originally designed to allow patients to see their test results in the units customarily used in their own country. To do that, the patient could switch between showing the results in two different measurement units: mg/dL, the standard used in the U.S., and mmol/L, which is used in many other countries.

The problem can occur if the measurement units switch without the patient realizing it. This can happen when the patient resets the date and time or changes the battery, or even if the meter is dropped or bumped. Then, if the patient just looked at the numbers without noticing the different units or the decimal point, he could incorrectly assume that his blood glucose level is too high or too low.

To help resolve the problem, all new Abbott meters now have the correct unit of measurement locked in place. Patients can continue to use the older units, but they should make sure that their meter displays the glucose test result in mg/dL. If patients don't know how to change the measurement units, or if the units can't be changed, they can contact Abbott Diabetes Care at 1-800-553-4105.

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January2006FDA Patient Safety News Homepage
Caution on Liver Damage and Cymbalta (Video, print, and e-mail functions)
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New precautions about liver damage have been added to the labeling for Cymbalta (duloxetine), which is used to treat major depressive disorder and diabetic peripheral neuropathic pain.

The labeling had already warned of hepatotoxicity from the drug, and cautioned that it should not be prescribed in patients with substantial alcohol use. Now, based on new reports of hepatitis in patients taking Cymbalta, the labeling states that the drug should not be administered to any patients with evidence of chronic liver disease.

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January2006FDA Patient Safety News Homepage
Novartis Ophthalmics Recalls Certain GenTeal Products (Video, print, and e-mail functions)
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Novartis Ophthalmics is recalling certain lots of two non-prescription products used to treat dry eye: GenTeal Gel and GenTeal GelDrops.

Test results on a small number of samples of GenTeal Gel lots indicated the presence of a mold that could cause eye infections in susceptible people, particularly those with compromised immune systems.

The two lots of GenTeal GelDrops are being recalled because they may not be sterile. While the risk of potential contamination for these drops is believed to be very low, the concern again is that the product could cause infections in susceptible people.

The five lots of GenTeal Gel being recalled are: Lot #Z12468, 10 ml, expiration date 01/2006; Lot #Z12912, 3.5 ml, expiration date 03/2006; Lot #Z12900, 10 ml, expiration date 04/2006; Lot #Z13161, 10 ml, expiration date 05/2006; and Lot #Z13314, 3.5 ml, expiration date 06/2006. The five lots include about 142,500 tubes that were distributed nationwide from March to November 2004.

The two lots of GenTeal GelDrops being recalled are: Lot #51139, 15 ml, expiration date 07/2007; and Lot #51283, 25 ml, expiration date 07/2007. The two lots include about 12,000 dropper bottles that were distributed nationwide in October 2005.

Consumers who have purchased GenTeal Gel or GenTeal GelDrops with any of these lot numbers should contact Novartis Ophthalmics at 1-866-393-6336.

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January2006FDA Patient Safety News Homepage
Higher Estrogen Exposure with Ortho Evra Contraceptive Patch (Video, print, and e-mail functions)
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Ortho McNeil Pharmaceuticals recently updated the labeling for the company's contraceptive patch, Ortho Evra. The new labeling warns that women using the patch are exposed to higher levels of estrogen than with most birth control pills.

A woman using the weekly patch may be exposed to about 60% more estrogen on average than if she were taking a daily birth control pill containing a typical 35 microgram dose of estrogen. However, the peak levels of estrogen are about 25 percent lower with the patch than with a typical birth control pill.

Increased estrogen exposure may increase the risk of adverse events such as blood clots, but at this point it's not known whether women using Ortho Evra have a higher risk of serious side effects than women taking typical birth control pills. Ortho McNeil Pharmaceuticals is conducting additional studies to examine this question.

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January2006FDA Patient Safety News Homepage
New Risk of Interference with Wireless Medical Telemetry Systems (Video, print, and e-mail functions)
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FDA has issued a Public Health Notification warning that after December 31, 2005, any medical telemetry systems that are still operating in the 460-470 MHz frequency band are at increased risk for interference, which could compromise patient safety.

Beginning on January 1, 2006, the Federal Communications Commission (FCC) started granting licenses for mobile radio transmitters operating in the 460-470 MHz band. It's estimated that there are several hundred thousand mobile radio users waiting for these new channels. Most of the radio users in this band will include hand-held and other mobile transmitters such as those operated by police; fire and rescue; taxis; and commercial trucks. These users could likely operate in and around a hospital.

FDA recommends that hospitals determine if the facility’s current wireless medical telemetry systems are operating in the 460-470 MHz frequency band. Hospitals still operating in that band should move to less vulnerable frequencies. FCC has reserved a certain portion of the radio spectrum for wireless medical telemetry. This part of the spectrum is known as the Wireless Medical Telemetry Service (WMTS).

Interference from TV stations broadcasting in the vicinity of hospitals could also be a growing problem because of Digital TV. The FCC is asking TV broadcasters to operate their new Digital TV transmitters at maximum power, and that can increase the potential for interference with medical systems. So if a hospital’s wireless telemetry equipment is still operating in the commercial TV frequencies, it's important to migrate out of those channels and into the bands reserved for medical uses.

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January2006FDA Patient Safety News Homepage
What to Do about False-Positive Troponin Test Results (Video, print, and e-mail functions)
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FDA has issued a Safety Tip about the possibility of false positive results when troponin testing is used to help diagnose acute myocardial infarction i.e., cases where the troponin immunoassay test is positive in the absence of AMI. False positive troponin tests are rare, but they can have serious consequences, because they can cause clinicians to suspect an acute MI when in fact none has occurred.

The Safety Tip lists the factors that can interfere with accurate analysis, including the presence of clots and certain antibodies in the patient's blood sample, and it gives methods for reducing or removing interfering antibodies from the sample. It notes that lab personnel should suspect the presence of interfering antibodies when the test results don't agree with the patient's clinical presentation or when they're not reproducible.

The Safety Tip also provides both clinicians and lab personnel with steps they should take if the troponin test doesn't match the patient's clinical presentation for AMI. For example, lab personnel should determine whether the patient is on anticoagulant therapy, examine the specimen for particles and clots, and re-run the specimen after doing a serial dilution to see if the results are linear.

Clinicians should consider repeating the troponin test, as well as performing additional diagnostic testing. They should bear in mind that other clinical conditions may cause an elevated troponin level, and that the troponin test is only one tool among many in diagnosing AMI.

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January2006FDA Patient Safety News Homepage
Warning on Patient Observation and Monitoring for Erbitux (Video, print, and e-mail functions)
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ImClone Systems and Bristol-Myers Squibb have notified healthcare professionals about new safety information for the drug Erbitux (cetuximab). Erbitux is used to treat certain patients with EGFR-expressing metastatic colorectal cancer.

The product labeling had already warned about the risk of severe infusion reactions in patients being treated with Erbitux. The labeling now warns that patients should be observed for one hour following Erbitux infusion because of this risk. Patients who do experience infusion reactions may need to be observed for more than one hour.

Patients being treated with Erbitux are also at increased risk for electrolyte abnormalities. So they should be monitored periodically for hypomagnesemia, and accompanying hypocalcemia and hypokalemia, both during therapy and after therapy is completed.

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 Advice for Patients

January2006FDA Patient Safety News Homepage
Certain Omron Thermometers Recalled (Video, print, and e-mail functions)
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Omron Healthcare is recalling certain Omron 3-Way Instant Thermometers because the thermometer tip may overheat and cause discomfort or burns to the person using it.

The Omron 3-Way Instant Thermometer has a tip that pre-warms so that a quick reading can be taken. In a limited number of these devices, this feature has malfunctioned and caused the tip to overheat, causing redness or a blister on the person's skin. Very young children may be particularly vulnerable if the tip overheats because they may have difficulty expressing themselves or pulling away if the thermometer is held by an adult.

The model numbers of the recalled devices are MC-600 and MC-600CAN with lot numbers beginning with 01-32, 01-36, 01-37 and 01-38. (Lot numbers are located inside the battery compartments of the thermometers.)

While there have been no reports of serious injury so far, the company is asking consumers to immediately stop using the recalled devices. They should call Omron at 1-800-634-4350 for information on how to return the thermometer and receive a refund or an exchange for a different model.

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