 This is FDA Patient Safety News. In this edition, the first biotechnology product for allergy-related asthma, a caution on using glucose monitors and neonates, what to tell patients about taking Prylasek OTC and trans-fatty acid information on food labels. 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 Reiner. Let's start with some medical products FDA recently approved. FDA recently approved the first biotechnology product to treat patients with asthma caused by inhaled allergens. It's called Zolare, and it's manufactured by Genentech. Zolare's established name is Amelizumap. Zolare has been approved to treat patients 12 years and older with moderate to severe allergy-related asthma that's not adequately controlled with inhaled steroids. The drug is a monoclonal antibody that blocks the body's immune response to inhaled allergens like dust mites or animal dander. It's given as a subcutaneous injection once or twice a month. Anita, there are about 17 million people in this country with asthma. What percentage of them are going to be candidates for this drug? Well, probably a small percentage for several reasons. First of all, Zolare is a second-line treatment. That is, it's intended for patients whose asthma has not been successfully treated with inhaled steroids. Second, it's not approved for children under 12, which eliminates a substantial proportion of asthma patients. And third, it's been shown to work only for patients with moderate to severe allergy-related asthma. How effective is it? Well, the effectiveness of the product was mainly assessed in two placebo-controlled trials of about 1,000 patients. During the six-month studies, 80 to 85 percent of Zolare patients had no asthma exacerbations compared to 70 to 75 percent of the patients treated with placebo. Any unanswered questions about this drug? Well, there is one, but its significance isn't known at this point. During the clinical trials, more patients treated with Zolare developed a new or recurrent cancer compared to control patients. The numbers aren't large, 0.5 percent among the Zolare patients versus 0.2 percent among the controls. But the firm is planning long-term studies to determine whether there's a relationship between Zolare treatment and cancer. The FDA has approved a new protease inhibitor called REITAS to treat HIV-AIDS that requires only two pills once a day. Other protease inhibitors can require patients to take up to 16 pills a day in addition to their other HIV medications, and that can be difficult for some people. REITAS is manufactured by Bristol-Myers Squibb and its generic name is Atazanivir sulfate. Clinical trials showed that patients receiving REITAS in combination with other antiretroviral agents experienced a decrease in viral load and an increase in CD4 cell counts. These benefits occurred in patients who had not been previously treated and also in those who had previously received other antiretroviral therapy. A major safety concern with protease inhibitors in general is that they tend to be associated with hyperlipidemia. REITAS appears to have minimal impact on cholesterol and triglyceride levels. The most common laboratory abnormality with REITAS is hyperbili rubenemia, with 15 to 24 percent of patients showing jaundice or scleral ichteris. In clinical trials, this was reversible upon discontinuation of the drug, and the jaundice did not appear to be associated with an increased risk of liver damage. FDA has cleared for marketing the first test to help diagnose West Nile virus infection in patients with suspected symptoms of the disease. The test is called West Nile Virus IgM Capture ELISA, and it's manufactured by Pan-Biolimited of Australia. This amino assay detects the level of viral specific IgM in a patient's serum during the first few days after a patient shows symptoms of viral encephalitis. This assay was evaluated using serum from over a thousand patients. The test correctly identified antibody in over 95 percent of confirmed West Nile virus disease cases. Because detection of antibody is not always specific in patients with acute viral infections, positive results should be confirmed by an additional test or by using the current CDC diagnostic guidelines for disease diagnosis. By the way, although the West Nile virus is primarily mosquito borne, last year there were cases of transmission by blood transfusion. Most people infected with the virus don't have symptoms, and so they aren't aware of their infection, and so people who are infected might unknowingly try to donate blood, and the FDA wants to make sure they don't do that. Although there aren't any West Nile tests approved by FDA for blood screening at this time, FDA is encouraging blood banks to test donated blood for West Nile using several investigational nucleic acid tests. In July of this year, many blood banks started using these experimental tests. In an earlier show, we talked about the new cipher coronary stent that gradually releases a drug intended to help prevent restinosis. Since the approval by FDA, about 100,000 patients have received this stent, and during that time, we've received a number of reports of stent thrombosis and hypersensitivity reactions occurring within 30 days of stenting. Mark, what's the connection between the stent and these thrombotic events? Well, that's not really clear right now. At this point it's uncertain what effect the cipher stent has on thrombosis risk and what factors may contribute to the risk. FDA is evaluating the reports and working with the stent manufacturer, Cortis Corporation, to analyze the problem. So what's to be done in the meantime? Well on July the 7th, Cortis issued a letter to healthcare practitioners with some advice. The letter encouraged them to follow labeled indications and instructions for use, since the exact cause of the thrombosis and the hypersensitivity reactions hasn't yet been determined, methods to prevent them can't be clearly defined at this point. However, the letter reminds physicians that the cipher stent is indicated for vessels that have not been previously treated and not for the treatment of restenosis. It also stresses the importance of matching the stent size to the vessel size, deploying the stent fully so it's in contact with the vessel wall and using an adequate anti-platelet regimen. The letter also highlights the importance of reporting adverse events to Cortis and to the FDA. Mark, it sounds like we're still in the fact-finding stages on this issue. Well we really are and as we find out more about the issue we're going to be alerting health professionals. We'll also cover it on future editions of FDA Patient Safety News and also on our websites so stay tuned. Here's a caution about measuring blood glucose levels in neonates and premature infants. Glucose testing is commonly done in infants to rapidly identify both high and low blood sugar. Some bedside glucose monitors will give falsely low results with neonates. That's because infants may have higher hematocrit levels than older children and adults and that can interfere with the function of some glucose meters which can lead to false readings. Why this happens isn't fully understood but there are several ways to help address this problem. First, check the labeling and instructions for glucose meters used on neonates and premature infants to be sure they're cleared by FDA for this use. Second, validate glucose meters by comparing them against a central laboratory's current reference method. It's also a good idea to periodically re-evaluate these meters against the reference standard and to develop quality assurance and quality control programs. And finally, if a glucose result in a neonate doesn't make sense, reassess the patient. If clinically appropriate, get a new sample and verify the result using an accepted reference method. There's a new medication guide for patients taking the drug larium which is used to prevent malaria. These written instructions were developed by FDA in cooperation with the drug's manufacturer Roche Pharmaceuticals. In addition to explaining how to take the drug, the guide alerts patients about the possibility of rare but potentially serious psychiatric side effects from larium and cautions them to contact a healthcare professional if they experience such symptoms as anxiety, depression, hallucinations, restlessness or confusion. It also explains that larium should not be used in people with a history of depression, mental illness or seizures. Roche Pharmaceuticals is also issuing a letter to physicians alerting them to the new medication guide and a letter to pharmacists reminding them that they're required to provide the patient with a copy of the guide each time a larium prescription is filled. The Institute for Safe Medication Practice has recently reported on a medication mix-up with the use of a two-channel infusion pump. These pumps are used to infuse two drugs through one pump. In the case cited by ISMP, Heparin was being infused through one channel and the anti-platelet drug agri-stat through the other channel. When hanging a new bag for each solution, the nurse inadvertently threaded the tubing for agri-stat through the channel already programmed for Heparin and vice versa. Luckily, the error was noticed before the patient was harmed. The same type of error could happen with triple-channel pumps or even with two single-channel pumps being used on the same pole. ISMP suggests the following practices to help avoid these kinds of errors. First of all, hang one solution at a time. Physically trace each line from the solution through the pump and then to the insertion site to make sure it's in the correct channel. If a high-alert medication is going to be infused, have one clinician hang the solution and ready it for infusion and another clinician independently validate the correct patient, the dose in concentration, the insertion site, and the pump or channel settings. Consider labeling each channel with the product being infused but don't rely only on the label to avoid mistakes. And finally, never use a dual-channel pump to infuse solutions into two different patients. True or false, MedWatch is a special timepiece used to keep track of when patients take their medications. False, MedWatch is a system that health professionals or consumers can use to report adverse events with medical products to the FDA. You can reach MedWatch through our website. Now for the part of the program that helps you answer questions about medical products and procedures that are on patients' minds. FDA recently approved the proton pump inhibitor Prilosec for over-the-counter sale and patients may be asking about taking it for their heartburn. The most important thing for patients to understand is that Prilosec O2C is for frequent heartburn, the kind of heartburn that occurs two or more days per week. So patients who have infrequent heartburn once a week or less should be told that Prilosec O2C is not for them. It's also not for people who want immediate relief from heartburn. For acute heartburn symptoms, they should be advised to use O2C and acids or acid reducers. Patients who do have frequent heartburn should be told that Prilosec O2C must be taken before eating once a day, every day for 14 days. They should understand that the drug may take one to four days for full effect, although some patients may get complete relief of symptoms within 24 hours. And they should be cautioned to wait at least four months before taking another 14-day course of treatment unless instructed by a doctor. If the frequent heartburn returns soon after the 14 days of treatment, patients should contact their physicians. Certain patients should be warned not to take Prilosec O2C. They include anyone who has had an allergic reaction to Prilosec in the past and anyone who has dysphagia, bloody vomitus or bloody or black stools. FDA has issued a new regulation that's gonna require manufacturers of foods and some dietary supplements to list the amount of trans fatty acids on the nutrition facts panel of the product label. Trans fatty acids are formed in the manufacturer of food products when liquid vegetable oils are hydrogenated to make them more solid. Well, what kind of food are we talking about here? Mainly processed foods. We're talking about things like vegetable shortening, crackers, cookies, some margarine, some salad dressings. Don't we already have fat information on the label? What's so important about trans fat that it requires a separate listing? Trans fats have emerged as an important public health issue. Like saturated fatty acids and dietary cholesterol, they raise low density lipoprotein or LDL levels and thus they increase the risk of heart disease. And so it's important that people know how much trans fatty acid they're getting when they purchase a food product. Now some manufacturers have already begun to list trans fatty acids on their nutritional labeling. Under the new regulation, all of them are gonna require to do so by January of 2006. But you know, it's one thing to have the information on the label, it's another thing to have people understand what it means. Well, and that's why the labeling is just one part of a larger FDA effort. We also plan to develop educational materials for consumers on the importance of lowering their intake of saturated and trans fat and cholesterol. And that should help to motivate them to read the nutritional labels on the foods they buy and avoid the ones with high levels of trans fat and saturated fat and cholesterol. You might be interested in using these education materials to help teach your patients about healthy eating. And we'll let you know as soon as they're available. 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 Reiner. And I'm Mark Barnett. See you next time. ["Pomp and Circumstance"]