 This is FDA Patient Safety News. In this edition, an expanded use for tamiflu and preventing influenza, new advice on Paxil and congenital malformations, and mix-ups between the drugs Anacar and Omicor. 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 story about preventing flu in children. FDA recently approved the use of tamiflu for preventing influenza in children 1 to 12 years old. Tamiflu was already approved as a preventive agent in patients 13 and older, and it's approved for treating the flu in patients older than one year. The approval was based on a study of the spread of flu in households. When someone in the household was diagnosed with seasonal flu, other family members received either tamiflu once a day for 10 days or no tamiflu at all unless they became ill. Three percent of the children receiving tamiflu prophylactically developed fever and other symptoms confirmed to be flu. That compared with 17 percent in the group receiving no preventive treatment. The benefit in children is similar to that seen in older individuals. Side effects from tamiflu taken prophylactically were similar to those in patients taking the drug therapeutically. In rare cases, anaphylaxis and serious skin reactions have occurred, so patients should be instructed to discontinue the drug if they develop an allergic reaction or severe rash. Patients should also understand that tamiflu is not a substitute for the flu vaccine and that they should continue to receive annual vaccinations according to immunization guidelines. Here's a story about a new way to administer antibody replacement therapy to patients with primary immune deficiency disease. These patients need regular treatment with immunoglobulin to prevent or fight off potentially life-threatening infections. Until now, immunoglobulin products have been administered either intravenously or intramuscularly. FDA recently approved a new one that's injected subcutaneously. It's called VivaGlobin and it's made by the German company ZLB Behring. VivaGlobin may be especially beneficial in patients who don't easily tolerate IV administration of IG because of poor venous access or serious side effects. And since it's injected on a weekly basis using an infusion pump, patients can self-administer the product at home. In clinical studies, VivaGlobin was well tolerated. The most common side effects were mild or moderate injection site reactions such as swelling, redness and itching. The contraindications for VivaGlobin are similar to other immune globulin products. In a recent edition of this program, we told you about a study that suggested an increased risk of congenital malformations in infants born to women taking paxil or generic peroxidine during the first trimester. Since then, the manufacturer has added new warnings to the labeling for paxil based on preliminary analyses of two recent unpublished epidemiologic studies. Both studies showed a relatively small increased risk for cardiac defects in infants born to women who received the drug in early pregnancy. And one of the studies also showed an increased risk of congenital malformations overall. In both studies, the most common types of cardiac abnormalities in children of women who took paxil were atrial and ventricular septal defects with a wide range of severity. Neither of the studies addressed the question of whether the risk might extend to use of the drug later in pregnancy. FDA is recommending that paxil generally not be started in women who are planning to become pregnant or who are in the first trimester of pregnancy. If a woman is already on paxil, the physician should alert her about the potential risk to the fetus. The physician should also consider discontinuing the drug in these women, although in individual cases the benefits of continuing paxil may outweigh the potential risk to the fetus. If paxil is discontinued, it should be tapered off and not stopped suddenly. We're going to update this story as more information becomes available. Ortho-clinical diagnostics has recalled certain lots of the company's vitro's Hepatitis B surface antigen confirmatory kit. This kit is used to confirm the presence of the antigen after a positive test with the vitro's Hepatitis B surface antigen reagent pack. Because of a problem with a diluting solution, the confirmatory kit may indicate not confirmed for some samples. So we could end up, as they understand it, with a person having, being infected with Hepatitis B, having a positive test, then having the confirmatory test come back and say not confirmed, and what you'd end up with is a false negative. Right, that could happen, and in this case, that patient might not receive the treatment he needed and the very real possibility that he might infect somebody else. But in most cases, patients will also have been tested for Hepatitis B core IgM antibodies. If that test is positive, the clinician will presume that the patient has had a recent infection with Hepatitis B virus, and so the patient will get the treatment. It seems as though it would be particularly worrisome if you got a false negative on a pregnant woman, because obviously that would have an effect on the child. That's right, it could be particularly worrisome because a pregnant woman might only be tested for Hepatitis B surface antigen and not the core IgM antibodies. That means that a not-confirmed test result would likely lead to her newborn infant not being treated appropriately at birth, and this can have grave consequences because without this treatment, the infant is likely to progress to a chronic Hepatitis B infection, and this can eventually lead to severe liver damage, the need for a liver transplant, or early death. I'm assuming that labs that have the affected lots of this confirmatory kit are supposed to stop using it. That's right, the company says stop using them and discard any stock that hasn't already been used. The company is also recommending that users go back and review the results that were previously reported by these confirmatory kits. Ortho has issued a question and answer sheet that specifies which results should be reviewed. Contact the company for this information, as well as the affected lot numbers. Polenkraut and Palatin Technologies have withdrawn from the market the imaging agent Neutrospec because of serious safety concerns. Neutrospec is used in nuclear medicine to help diagnose patients with equivocal signs and symptoms of appendicitis. It's also been used off-label for diagnosing osteomyelitis and other infections. We've received reports of 17 patients receiving Neutrospec who developed life-threatening cardiopulmonary side effects. These events occurred within minutes after injection and required that the patient be resuscitated with fluids, vasopressors, and oxygen. In two cases, the patients died. There's no evidence that patients who've already received the drug safely face any long-term risk. FDA is working with Palatin Technologies to evaluate these adverse events and try to determine whether further studies are needed to develop safer uses of the product. Meanwhile, healthcare providers must stop using Neutrospec and contact the manufacturer immediately about returning all existing stocks. If a patient should receive Neutrospec despite this advice from the company and the FDA, he or she must be closely monitored for at least one hour after the drug is administered. Trained personnel and equipment should be on hand during that time to resuscitate the patient if needed. Patients with underlying cardiopulmonary conditions may be at higher risk for serious complications. GlaxoSmithKline has notified health professionals about reports of diabetic macular edema in patients receiving a vandia or rosa glidazone malleate, which is used to treat type 2 diabetes. These reports involve both new cases of macular edema and worsening of existing cases. In the majority of instances, patients also reported concurrent peripheral edema. In some cases, the macular edema resolved or improved when the drug was discontinued, and in one case, it resolved after the dose was reduced. Logan Pharmaceuticals has notified healthcare professionals about revised labeling for avinza morphine sulfate extended-release capsules. These changes highlight warnings that patients should not consume alcohol while taking the drug. These warnings are based on FDA laboratory studies of avinza. In these studies, morphine was released from the extended-release tablets earlier than expected when the tablet was exposed to alcohol, and this effect increased dramatically with increasing alcohol concentration. Although it's not clear that these findings are relevant to a clinical setting, patients who use avinza should be told that they must not drink alcohol and they must not use medicines that contain alcohol. Consuming alcohol while on the drug could result in the rapid release and absorption of a potentially fatal dose of morphine. Periodically on this program, we point out mix-ups that occur between drugs with similar names. This time, we're talking about two drugs whose names both sound and look alike, amicar and omicor. Amicar, an anti-fibrinolytic agent available for many years, is used to enhance hemostasis. Omicor is a relatively new product. It's a preparation of omega-3 fatty acids that's used along with diet to lower very high triglyceride levels. The Institute for Safe Medication Practice has recently described a case where a pharmacist misunderstood a telephone order for omicor 1 gram BID as amicar 1 gram BID. Fortunately, the patient read the drug information sheet before taking the medication and called to let the pharmacist know that he was expecting a drug that reduces triglyceride levels. ISMP says that if a patient inadvertently took amicar instead of omicor, the risk of thrombosis would be increased along with a host of other adverse reactions. And substituting omicor for patients that truly need amicar may be even more significant, possibly leading to serious bleeding conditions. FDA has received several other reports of mix-ups between these two drugs, and we're working with the manufacturers to find ways to reduce the chance for confusion. In the meantime, ISMP says to set an alert in the order entry computer system, match the drug's indication to the patient's diagnosis before dispensing either of these drugs, and consider using tall man letters to help distinguish between the two drugs when both are available in the inventory. Your patients are now going to have more information about whether packaged foods contain ingredients to which they're allergic. That's because effective January 1st, 2006, FDA is requiring food labels to state clearly whether the product includes ingredients that contain proteins that are derived from one of the eight major food allergens. Those are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Well, food labels are already required to list all the ingredients in the product. Well, that's true, but now any ingredient that contains one of these allergenic proteins has to be clearly identified and in plain English. For example, if a product contains casein, which is a milk protein, the label now has to use it to her milk so that a person allergic to milk can understand that he or she should avoid this product. Now, that's especially important for children and their caregivers because they have to learn to recognize the presence of substances that they have to avoid. Now, you said the new labeling requirement applies to the eight major food allergens, but people are allergic to other foods. That's right, about 160 foods have been identified as possibly food allergens, but those eight account for about 90% of all of the food allergies in the U.S. And the requirements are pretty specific. The label can't simply say fish. It has to state flounder, for example, or cod. And the same holds true for the type of nut the food contains or the type of shellfish. Well, people tend to eat out frequently these days. What about food that's prepared in restaurants? The new law doesn't extend to food that's prepared in restaurants. So if you have a food allergy, you're still going to have to ask questions in the restaurant about ingredients. The law also doesn't apply to fresh fruits and vegetables and it doesn't apply to highly refined oils that are made from one of the eight major food allergens, like highly refined peanut oil or soybean oil, because these oils are not considered to be major food allergens. Well, how soon can we expect to see these improved food labels on the shelves? Any food that's labeled after January 1, 2006 has to have the new labeling, but the new law does not require that foods already on the shelves be removed or relabeled. And that means that for some period of time, shoppers are going to continue to see foods in the marketplace that don't yet have the new labeling. 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 Anita Rayner. And I'm Mark Barnett. See you next time.