 This is FDA Patient Safety News. In this edition, a new test to help predict the risk of coronary heart disease, more information on cochlear implants and bacterial meningitis, mix-ups with drugs that begin with the letter Z, and new recommendations on treating latent TB. 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 some medical products FDA recently approved. The FDA has cleared for marketing a new lab test that will help establish a patient's risk for coronary artery disease. The test is called PLAC, and it's manufactured by Diodexus Incorporated. It works by measuring serum levels of an enzyme that's manufactured by macrophages called lipoprotein-associated phospholipase A2. Elevated levels of this enzyme correlate with an increased risk of coronary artery disease. So, Mark, is the PLAC test supposed to be used in place of other lab tests like triglycerides, LDL, total cholesterol? It's not supposed to replace anything. It simply adds information about a patient's risk of coronary artery disease, and it's not supposed to be used alone. It provides supportive information when it's used in conjunction with a clinical evaluation and an appraisal of other blood tests and risk factors. When this test was studied, there was one group of patients where the results were particularly clear-cut. That's right. We're talking here about patients who had a relatively low level of low-density lipoprotein, the so-called bad cholesterol. The test was cleared based on a study of blood samples collected from over 1,300 patients over a nine-year period. Now, among patients with an LDL level below 130 milligrams per deciliter, those who had a high PLAC level experienced two to three times the risk of coronary artery disease than those with a low PLAC level. So, what's the most important thing to remember about this new test? Well, the bottom line to remember is that this is a new tool to help assess coronary artery disease risk, but it's got to be used along with other tools. FDA recently approved a new use for the photosensitizing agent, Photofrin. It's now approved for ablating high-grade dysplasias in patients with Barrett's esophagus who don't undergo esophagectomies. Photofrin, also called Porfum or Sodium, is distributed by AXKEN Scanda Farm. It was previously approved to treat several types of cancers as part of photodynamic therapy. During photodynamic therapy, Photofrin is injected into the patient where it's initially absorbed by body tissues. Over the next couple of days, the drug will largely be eliminated from most healthy tissues but remain in the abnormal cells. In the endoscope, laser light is then delivered by fiber optic to the treatment area. The Photofrin in the abnormal cells absorbs the laser light rays and sets off oxygen radicals, which kill the cells while limiting damage to surrounding healthy tissue. The clinical study supporting this new use of Photofrin photodynamic therapy showed that patients receiving this treatment were more likely to achieve complete reversal of their pre-cancerous lesions in Barrett's esophagus compared to controls. Two-year follow-up data from this clinical study showed that patients receiving this therapy had an 80% chance of being cancer-free, while control patients had a 50% chance of being cancer-free. The effectiveness of Photofrin photodynamic therapy in reducing the risk of esophageal cancer beyond two years has not been demonstrated. The side effects of Photofrin phototherapy treatment include esophageal strictures and photosensitivity reactions that can last for several weeks. The drug's labeling includes information on precautions that should be taken to avoid exposure of the skin and the eyes to bright light. FDA recently licensed the first clotting factor for patients with hemophilia A that's produced without using additives derived from human or animal blood. It's called ADVATE, and it's manufactured by Baxter Healthcare Corporation. ADVATE is an anti-hemophilic human factor-8 product used to prevent and control bleeding episodes in people with hemophilia A or to prepare them for surgery. So, does the fact that this product is made without any blood additives make it safer than the ones that are out there already? Well, the current products, both the ones that are derived from plasma and the ones that are made from recombinant DNA are already considered very safe. That's because of technological advances in manufacturing where viruses are inactivated and removed. That minimizes the risk of transmitting infectious agents with factor-8 products, but avoiding the use of blood-derived additives in manufacturing this new product gives added reassurance against any theoretical risk of infection. In a previous edition of FDA Patient Safety News, we told you about a possible link between cochlear implants and bacterial meningitis. We now have new information on that story. A recent CDC FDA study found that children with cochlear implants were at greater risk for streptococcal meningitis than children in the general population. The study reviewed the medical records of over 4,200 children who were under the age of six when they received the implants. 26 of them were reported to have developed meningitis. One finding in the study was that cochlear implants that had electrode positioners were more likely to be associated with meningitis than other models. The models with the positioners are no longer on the market. How long after the cochlear implants were put in did it take for meningitis to show up? Among the cases that were reported in the U.S., that ranged from about 24 hours after the surgery up to over six years after the surgery. If it can take that long for meningitis to occur, how about trying to reduce the long-term risk in kids who have the cochlear implants with positioners, remove them, and replace them with other models? Well, the CDC and the FDA did not make that recommendation because it's not known whether the risk of the additional surgery might actually outweigh the risk of having the positioner. Well, positioners aside, are there any ways to reduce the risk in kids who are going to get cochlear implants or for those who already have them? Well, the recommendations on that really haven't changed much since the last time we reported on this story. First of all, consider prophylactic antibiotic treatment prior to implanting these devices. Second, promptly diagnose and treat otitis media and patients who already have the implants. And third, for patients who are going to receive the implants or who already have them, follow vaccination guidelines against the organisms that commonly cause bacterial meningitis. You can find CDC's vaccination recommendations on our website. And CDC's national immunization program has a hotline that provides advice on which vaccines are recommended for cochlear implant patients. The hotline number is 1-800-232-2522. Periodically on this program, we point out mix-ups that occur when drug names look or sound alike. This time, we're talking about confusions that have occurred between three drugs that all begin with the letter Z. Zantac, an acid reducer, Zyrtec, an antihistamine, and Cyprexa, an antipsychotic. First take Zantac and Zyrtec. FDA's received a number of reports of pediatric medication errors that occurred when Zantac syrup was prescribed, but Zyrtec syrup was dispensed. These two drugs don't have overlapping dosage strengths, but they are both available as a syrup and they're both available in amber one-pined bottles. And the names both look alike and sound alike. There are also reports of mix-ups between Zyrtec and Cyprexa. The Institute for Safe Medication Practices points out that many of these mix-ups probably occurred when only the first two letters of the drug name were seen by practitioners when reading prescription orders or container labels. Since both drugs are available in 5 milligram and 10 milligram tablet strengths, this increases the possibility of confusion. ISMP describes a patient who accidentally took Cyprexa instead of Zyrtec and then suffered a head injury after losing consciousness. In another case, a previously controlled psychotic patient took Zyrtec instead of Cyprexa and then relapsed. To help alleviate this problem, the manufacturer of Cyprexa has redesigned the product's label using tall man lettering to highlight the unique letters in the name. Here are some ways that you can prevent these kinds of mix-ups. Educate the staff about the medication errors caused by these name confusions. Separate look-alike or sound-alike drugs on the pharmacy shelves. Include the indication for the drug on the prescription. Use name alerts or reminders about the potential for error on computer systems, drug containers, and drug storage shelves. In a situation similar to the Zyrtec and Cyprexa mix-ups, tell patients about the risk of a mix-up and advise them to look at their medication to be sure that it has the right appearance. GlaxoSmithKline has notified healthcare providers about a high rate of early virologic non-response in HIV-infected patients receiving a particular three-drug antiretroviral regimen. The three drugs are epivir or lamiviodine, zyagen or abacavir, and viriad or tenofivir. This virologic non-response was observed in a company-sponsored clinical trial of HIV-1-infected patients who had not been previously treated with antiretrovirals. Based on the clinical study results, GlaxoSmithKline says that abacavir and lamiviodine in combination with tenofivir should not be used as a triple antiretroviral therapy when considering a new treatment regimen for either naive or pretreated patients. Any patient currently controlled on therapy with this combination should be closely monitored and considered for modification of therapy. And any use of this triple combination with other antiretroviral agents should be closely monitored for signs of treatment failure. For more information, go to our website. In a previous story, we described a number of cases where the tubing from a patient's blood pressure monitor was mistakenly connected to his IV port. Some of these cases resulted in the patient dying from an air embolism. This time, we want to draw your attention to a similar case. This time, it involved the air hose from a sequential compression device that's used with anti-embolism stockings. An FDA article in Nursing 2003 describes the report of a confused patient returning from the bathroom. The patient mistakenly attached the air hose from his sequential compression device to his IV tubing rather than to the anti-embolism stocking. Luckily, the compressor was turned off and the air didn't enter the IV tubing. If it had, the patient could have sustained an air embolism and died. Again, the cause of this problem goes back to different devices intended for very different uses, having compatible lure connectors that allow them to be attached to one another. The article points out two ways to minimize the risk. First, if you're using lure connectors, you should always be alert to the possibility of inadvertent cross-connections. Follow the manufacturer's recommendations and cautions regarding compatibility with other devices. And if you notice potentially dangerous compatibility issues, notify your facility's risk manager and biomedical department. Second, be aware that confused patients like the one cited in the article may be at special risk. It's important to check on them frequently and to remind them to call for help if they need to get out of bed. True or false? FDA conducts laboratory and clinical testing on a new medical product before allowing it on the market. False. FDA requires that the testing be conducted by the manufacturer who wishes to market the product. FDA's job is to review the results of these tests and decide on whether the product can be marketed. CDC and the American Thoracic Society are now recommending that patients with latent tuberculosis infection not be treated with the combination of rifampin and pyrazinomide because of the risk of severe liver injury. These revised recommendations were published on August 8, 2003 in the MMWR. In early 2000, CDC and the American Thoracic Society first recommended a two-month regimen of rifampin plus pyrazinomide for treatment of latent TB infection. Shortly after this, CDC started receiving reports of liver injury in patients on this therapy and based on these initial reports, CDC cautioned clinicians about using the two drugs in combination and advised additional monitoring of patients. In the August MMWR issue, CDC reports on 48 confirmed cases of severe liver injury associated with this combination therapy, including 11 deaths. This led to the latest recommendation that the combination of rifampin plus pyrazinomide generally should not be offered to patients with latent TB infection. The preferred regimen for treating latent TB is isoniazid for nine months. Alternatives are isoniazid for six months or rifampin for four months. CDC notes that this recommendation does not apply to treating active TB disease, where using rifampin and pyrazinomide in multi-drug regimens may be appropriate. And CDC continues to emphasize that treatment of latent TB infection is a key component in the effort to eliminate tuberculosis. 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 Rayner. See you next time.