 This is FDA Patient Safety News. In this edition, a new genotyping test that can help select a patient's medications and individualized doses, a public health advisory about the use of NSAIDs, a warning about liver injury in patients taking Stratera, and more on preventing fatalities from medical gas mix-ups. 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 Rayner. Let's start with a medical product FDA recently cleared for marketing. FDA has cleared the first laboratory test system that uses DNA microarray technology to provide genetic information that can help select a patient's medications and individualized doses. It's called the AmpliChip Cytochrome P450 Genotyping Test and it's manufactured by Roche Molecular Systems. FDA clearance of this product paves the way for similar tests to be developed in the future. Using a blood sample, the new test analyzes an enzyme from one of the genes in the cytochrome P450 family of genes. Variations in this gene can affect the patient's ability to metabolize certain drugs, including some antidepressants, antipsychotics, beta blockers, and chemotherapeutic agents. This test can't be used by itself to determine optimum drug dosages. It's intended to be used along with clinical evaluation and other tools. FDA recently issued a public health advisory about the use of NSAIDs, including COX-2 selective agents such as Celebrex and Bextra. This seems to be a rapidly changing situation. Now there's evidence about cardiovascular events. That's right. Recently released data from controlled clinical trials suggests that these COX-2 selective agents may be associated with an increased risk of serious cardiovascular events. In these studies, the increased risk was associated with long-term use of the drugs or use in very high-risk settings, immediately after heart surgery, for example. Now you're talking about studies with recently released data. How do those studies compare with studies that have already been done on these drugs? Well, the results from these studies are preliminary, and in fact, they conflict with results from other studies of these same drugs. Still, FDA is making some interim recommendations at this time. In essence, we're advising prescribers of Celebrex or Bextra to consider this emerging information when they're weighing the benefits against risks for individual patients. Well, now on the benefit side of the equation, there are some patients who would be appropriate candidates for these drugs. That's right. In some patients, the benefits may outweigh the risks. They include patients at high risk of GI bleeding, who have a history of intolerance to nonselective NSAIDs or who aren't doing well on nonselective NSAIDs. And on the other side of the equation, you have to take into account the patient's individual risk for cardiovascular events and other adverse reactions to NSAIDs. It's a different situation for each patient. Well, this sounds like it's a continuing story. It is. FDA is analyzing the most recent studies of both COX-2 selective and nonselective NSAIDs to determine whether additional regulatory action is needed. We'll update our website as more information becomes available. In early December, UNO Medical Incorporated recalled certain airway adapters because several of them were found to be occluded and that could interfere with the patient's ability to breathe. The recalled adapters were used in a number of products, including nebulizer circuits, ventilator circuits, anesthesia circuits, transport circuits, and face masks. These products were sold under UNO Medical's Hospitac brand name and also under the names Viasis, UNO Medical, Drager, and Biomed Devices Incorporated. Although the recalled products were primarily used in hospitals, some were also sold for home use. If you or your patients have products made by Hospitac, Viasis, UNO Medical, Drager, or Biomed Devices Incorporated that use these airway adapters, you should check with UNO Medical Incorporated before using them. If you're unsure of the manufacturer or model number of your airway adapters, you may want to get this information from your supplier. You'll find a complete list of the recalled products and the model numbers on our website along with a phone number of UNO Medical Incorporated. FDA is advising health professionals about a new warning for the drug Stratera used to treat attention deficit hyperactivity disorder in adults and children. The drug's labeling is being updated with a bolded warning about the potential for severe liver injury in patients taking Stratera. The label warns that severe liver injury can progress to liver failure in a small percentage of patients. It cautions clinicians to discontinue the drug in patients who develop jaundice or laboratory evidence of liver injury. It also notes that the actual number of cases of severe liver injury from the drug is not known because of underreporting. Stratera's manufacturer, Eli Lilly, has agreed to send a letter to physicians alerting them to the new information. The company will also update the patient package insert to include information about the signs and symptoms of liver problems. If you learn of unexpected adverse events with Stratera including liver damage, please report them either directly to Eli Lilly or to FDA's MedWatch program and you'll find the addresses on our website. Today we want to remind you about an important FDA program called MedWatch. MedWatch allows healthcare 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 Xivox. Within the first six months of Xivox's marketing, FDA began getting MedWatch reports of myelosuppression from clinicians who suspected that the drug might be responsible. After investigating the problem, we worked with the manufacturer to change the Xivox 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, which is a heart medication, and what used to be called lavoxin, which is a thyroid medication. As a result, FDA asked the manufacturer to change the name of lavoxin, and now it's known as lavoxil, 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 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. 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 the FDA that problems may be occurring. It's important to keep the MedWatch system working, and we can't do that without your help. Here are the kinds of reports we need from you. First of all, we're asking that you report any serious adverse event that might be associated with a drug, a biologic, a medical device, or a dietary supplement. And by serious, we mean fatalities, hospitalizations, and medically significant events. We're especially interested in serious adverse events that are not listed in the product labeling. Secondly, report therapeutic failures, cases where the drug or device failed to work as it should. For example, let us know if a patient has to switch from one brand of a drug to another because the original one was ineffective. Third, tell us about 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 the packaging. And finally, we'd like to know about product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions, and poor packaging. We encourage you to report 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. You'll find more complete information on what to report and how to report on our website. Santa Cora has notified healthcare professionals about new warnings for Remicade, a drug used to treat rheumatoid arthritis and Crohn's disease. The new safety information describes rare but severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and colostasis in patients being treated with Remicade. These reactions occurred between two weeks to more than a year after the Remicade treatment was started. Some of these cases were fatal or resulted in liver transplants. So Santa Cora says that patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. Remicade should be discontinued if patients develop jaundice or if their liver enzymes become elevated to a level that's five or more times the upper limit of normal. The company also notes that Remicade, like other immunosuppressive drugs, has been associated with the reactivation of hepatitis B in chronic carriers of this virus. The company says that these patients should be evaluated and monitored before and during treatment with Remicade. In previous programs, we reported on patient deaths from medical gas mix-ups where patients were accidentally given the wrong gas, such as nitrogen or CO2, instead of oxygen. We stressed that these fatalities could be prevented by not using adapters and not changing the connectors or fittings on gas containers to make them fit the oxygen connector on the patient's gas delivery system. These fatalities continue to occur. The Institute for Safe Medication Practices recently received a report about an oxygen flow meter being forced into a nitrous oxide wall outlet that was immediately adjacent to the oxygen outlet in a radiology suite. Instead of receiving oxygen, the patient received nitrous oxide and died. Two factors played a part in this incident. First, because the room was dimly lit in preparation for a CAT scan, the technician wasn't able to distinguish the blue color of the nitrous oxide connector from the green color of the oxygen connector. And second, the pin index safety system on the oxygen flow meter was broken at the time. Since the pin system is designed to prevent incorrect connections, a flow meter with a broken or missing pin should never be used. ISMP points out that the opportunity for errors of this kind may increase as general anesthesia is used more often outside the OR. For example, more invasive procedures with general anesthesia are being conducted in radiology, and general anesthesia is used in bronchoscopy, cardiac cath, and endoscopy. Here are some of the things ISMP recommends to help reduce the likelihood of this kind of gas mix-up error. First, standardize the type of flow meters, regulators, and connectors that are used throughout your facility and use only those with indexing systems to help prevent misconnections. Second, make sure that the labeling of all gas connections and sources is visible during actual use conditions, such as in dim light or under crowded conditions. Third, if a patient doesn't respond to treatment with supplemental oxygen, consider the possibility that the wrong gas is being administered and immediately check the connections. Using an oxygen saturation monitor can provide an early alarm of hypoxic gas delivery to the patient. Finally, be sure that biomedical engineering staff perform regular preventive maintenance on gas delivery systems and that only trained and certified personnel are allowed to use or service this equipment. In a previous program, we cited reports from the Institute for Safe Medication Practices about dangerous mix-ups between two drugs whose packaging looks similar. Brethene or Turbutylene sulfate and methargyne, methyl-argonavine malleate, are used frequently in labor and delivery settings, but they're pharmacologic opposites that are used for very different clinical reasons. Brethene is used off-label to treat preterm labor and methargyne is used primarily after delivery of the placenta to treat hemorrhage and failure of the uterus to contract. Methargyne shouldn't be used in pregnancy except after the delivery of a newborn and it's especially dangerous to a patient in preterm labor. Despite previous warnings, ISMP recently reported on another error that occurred because the ampules of these two products look alike. Both drugs continue to be available as one milliliter ampules package in amber plastic tubs that are covered by a foil label with the product name in tiny print, which makes them difficult to tell apart. Both ampules also have similar colored rings around their necks and that makes them look even more alike. The manufacturer of Brethene AAI Pharma now packages the drug in vials instead of ampules to reduce the chance of mix-ups. But ISMP says that even though Brethene ampules were last shipped in January 2004, the ampules may still be available in the supply chain. So ISMP recommends that hospitals and birthing centers that still have Brethene ampules immediately replace them with vials. Well, that's all for this edition of FDA Patient Safety News. 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 alert 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 Mark Barnett. And I'm Anita Reiner. See you next time.