 This is FDA Patient Safety News. In this edition, a DNA-based test to detect cystic fibrosis, an alert on certain life-scan blood glucose meters, a recall of some neurontin capsules, and the dangers of MRI exams and patients with neurological stimulators. These stories and more on this edition of FDA Patient Safety News. Welcome to the program. For the U.S. Food and Drug Administration, I'm Mark Barnett. And I'm Anita Rainer. Let's start with a medical product FDA recently approved. FDA has approved the first DNA-based test to help detect cystic fibrosis. The test, called the Taget Cystic Fibrosis Kit, is made by the Canadian company TM Bioscience Corporation. A DNA sample from the patient's blood is analyzed for a group of variations in the gene-causing cystic fibrosis, the CFTR gene. The results can help in the clinical diagnosis of possible CF. It can also help couples identify if they are at risk of having a child with CF and help in newborn screening to identify infants affected with this disease. However, the Taget test should not be used as a standalone tool to diagnose CF because it detects just a limited number of the more than 1,300 genetic variations in the CFTR gene. In interpreting the test results, physicians should take into account the patient's clinical condition, ethnic background and family history. Also, patients may need genetic counseling to help them understand the test results. LifeScan Incorporated is notifying users of some of the company's blood glucose testing systems about possible problems that might cause misinterpretation of glucose test results. The affected meters are the one-touch ultra, the one-touch fast take, and the in-duo systems. When setting the meters date and time, it's possible for the user to accidentally change the measurement units and thus misinterpret the test results. Over the past year or so, we've received several dozen reports of these kinds of errors. Isn't it unusual for the patient to be able to change the unit of measurement on these meters? As you know, models with this feature are made by other companies, too. These models were originally designed to allow the patient to see their test results in the units that are customarily used in their own countries. To do that, the patient can switch between showing the results in two different measurement units, milligrams per deciliter, the standard used in the U.S., and millimoles per liter, which is used in many other countries. The problem is that the patient can't change the measurement units without realizing it. And then just looking at the numbers misinterpret the results and incorrectly assume that the blood glucose level is too high or too low. Now, there are some situations where that switch in the units will take place even if the patient doesn't do anything. That's right. If the unit is dropped while it's being used, it can accidentally switch the units. This can cause a brief power loss which can change the measurement units or the number used to program the meter to match a particular vial of test strips. Or it can change the 14- to 30-day glucose average calculated by the meter. So what's life scan doing to correct the situation? Well, the company has issued a worldwide notification to both users and healthcare professionals, and they're including special instructions in each package of test strips. Now, if I'm a health professional, I know I have patients that are using this meter. What do I tell them? The most important thing is to remind patients to make sure that their meter is set to milligrams per deciliter each time they test. They should also confirm that the code number on the meter's display matches the code number on the test strip vial. Remember, the meters in question are the one-touch ultra, the one-touch fast take, and the enduo systems. Patients can call life scan customer service at 1-800-515-0915 to confirm that their meter is set to the proper measurement units. Pfizer recently recalled certain bottles of its epilepsy drug Neurontin or Gabapentin. Because of a mechanical failure during manufacture, some of these bottles may contain empty or partially filled capsules. So patients taking these capsules could be underdosed and experience seizures. At this time, only one lot of 100-milligram Neurontin capsules is known to be affected by this problem. It's lot number 15224-V, and it was distributed in October and November 2004. Pfizer has contacted distributors and pharmacists about the recall. The company has also asked pharmacists to immediately contact their customers who use Neurontin. Patients taking Neurontin should not discontinue the drug before consulting with their doctors. If they filled a prescription for the product and its 100-milligram strength between October 1, 2004 and March 15, 2005, and they're concerned that any unused capsules may be part of the recalled lot, they should contact their pharmacist. Consumers can contact Pfizer medical information at 1-800-438-1985 if they have questions about the recall. Now for news about two recent recalls of different defibrillator products. The first recall applies to certain AED-20 automatic external defibrillators made by MRL Incorporated, a Welsh Allen company. These defibrillators are being recalled because impact to the device could cause an electrical short, which could prevent the device from analyzing the patient's ECG and thus prevent the defibrillator from delivering a shock. When this malfunction occurs during use, the AED-20 defibrillator may display an error message that says defibcom. We've received a number of complaints related to this problem, including one instance which may have prevented a patient from being resuscitated. In May, the company started to notify affected customers. It's providing customers with a loaner device at no cost while their unit is being serviced and will pay costs associated with shipping, handling and corrective service. You can call the company at 1-800-462-0777 if you think you may have one of these devices. Now for the second recall. Lairdoll Medical Corporation is recalling all lots of an adapter cable that's used with certain HeartStart and Philips Medical System codemaster defibrillators. Wires within the affected cables could break, and if that happens, it could prevent the device from delivering a shock. We've received a number of reports about this type of malfunction, including several that resulted in failure to resuscitate. The recalled devices are the CM100 HeartStart adapter cables. These adapter cables allow the Lairdoll HeartStart multifunction defibrillator pads to be used with several different defibrillator models, including the HeartStart 4000 defibrillators and the Philips Medical System's codemaster 100 and XL series defibrillators. The part number for these cables is 920-650. If you have any of these adapter cables should stop using them and order alternative cables from Philips Medical Systems. For more information on either of these two recalls, go to our website. Burlex Incorporated has issued a reminder to practitioners about the possible hepatotoxicity of beta-seron or interferon beta-1b, which is used to treat relapsing forms of multiple sclerosis. The company's letter notes that there have been rare reports of serious hepatic injury leading to hepatic failure and transplant in patients on beta-interferon products. It reminds practitioners that the prescribing information for this drug recommends liver function tests at one, three and six months after starting beta-seron therapy and periodically thereafter if the patient has no symptoms of liver toxicity. Kingswood Laboratories is recalling its moisture oral swab sticks because the product may be contaminated with molds, including aspergillus and penicillium. Using the contaminated swab sticks could result in respiratory infections, especially in patients with compromised immune systems. These swab sticks, which are used to moisten the mouths of patients were distributed to hospitals, wholesalers, pharmacies, nursing homes, medical and dental offices and consumers, and some of them were given as free samples. The swab sticks are packaged as three sticks in a white foil pouch with the name moisture and green letters on the front of the pouch. The recall includes moisture swab sticks with lot numbers A2, 1193, 1209, 1233, 1260, and 1725. The lot numbers are embossed on the pouch. If you have swab sticks in the recalled lots, you should stop using them immediately and return them to the point of purchase. And if you know of patients who are using this product, you should warn them to stop doing so. FDA recently issued a notification to healthcare professionals warning about the possibility of serious injury if patients with implanted neurological stimulators undergo MRI exams. The injuries reported to the FDA have included coma and permanent neurological damage. They were likely caused by heating of the electrodes at the tip of the leads. Didn't we talk about similar injuries that occurred in patients with these implants when they underwent diathermy treatment? Yeah, about two years ago we did a story about patients with these neurological implants getting diathermy and having serious injury. In fact, patients with deep brain stimulators died as a result of getting diathermy. And now with MRI, which is used a lot more than diathermy, the chances for injury are that much greater. So patients getting these stimulators ought to be cautioned about getting MRI exams. Yeah, the FDA notification warns that physicians who either implant these stimulators or monitor patients who have them should warn patients that if an MRI procedure is prescribed, they should check back with a monitoring physician and make sure, in fact, that they can be performed safely. Health professionals should remember that a fairly wide variety of products are neurological stimulators. They include neuromuscular stimulators and also those designed to stimulate the deep brain, the spinal cord, the vagus nerve and peripheral nerves. But let's say a patient with one of these stimulators fails to check back with the physician. Presumably the radiologist's office is the very important line of defense. And so the FDA notification, the basic thing it says to radiology personnel is be sure to screen patients for the presence of implants before you do an MRI exam. If the patient does have an implanted neurological stimulator, then consider consulting with the referring physician about other imaging options. Now if it's decided that an MRI procedure is indicated, be sure to review the labeling for the specific model stimulator and pay particular attention to warnings and precautions. For some stimulators the labeling may specify the types or strengths of MRI equipment that can be used, but with other stimulators, certain MRI procedures simply cannot be performed. But once a patient has had his implant removed, this isn't an issue any longer. That's not necessarily the case because sometimes an implant is removed, they take out the pulse generator, but the leads remain in place in the patient. Those leads can be heated by the MRI and cause a problem as well. So it's important not just to ask about present implants, but ask the patient whether they've had implants in the past. Go to our website and you can see the complete FDA notification. Bedford Laboratories, a division of Benvenu Laboratories is recalling one lot of Femadidine Injection, 20 milligram per 2 milliliter, because the company could not assure the sterility of the product. Femadidine Injection is used in some patients with pathological hypersecretory conditions or intractable ulcers, or as a short-term alternative for patients who can't take all Femadidine. The affected lot number is 609336 with an expiration date of April 2006. This lot was distributed in August 2004 to wholesalers and distributors and they distributed the product to hospitals. If you have any vials of this lot of Femadidine Injection, stop using it. Contact Bedford Laboratories at 1-800-562-4797 to return the product. True or false? Off-label use of medical products is prohibited by the FDA. False. FDA can't require that practitioners prescribe or use a product only according to its labeled indications or labeled dose. But good medical practice requires that physicians use these products according to their best knowledge and judgment. If a physician uses a product for an indication that's not in the approved labeling, he or she has the responsibility to be well informed about the product, to base its use on science and sound medical evidence, and to maintain records of the product's use and its effects. That's all for this edition and remember, you can get more information on all the stories you've seen here today by visiting our website. We also urge you to use the website to report problems you've encountered with medical products. That's how we learn about problems so we can learn others. We'll be back next month with another edition, so watch for us. Until then, for the U.S. Food and Drug Administration, I'm Anita Reiner. And I'm Mark Barnett. See you next time.