 This is FDA Patient Safety News. In this edition, a new rapid test for HIV, a recall of oral swabs because of a choking hazard, and new warnings about serious skin reactions to the drug Bextra. 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. In this series of broadcasts, we're talking about patient safety when it comes to using drugs, biologics, and medical devices. About new products you may find useful in patient care. About potential safety problems and tips on how you can avoid them. You can get more information about any of the stories in this broadcast from our FDA Patient Safety News website. Let's start with our new products bulletin board and tell you about some products FDA recently approved for marketing. You can find information on all FDA-cleared medical products on FDA's website. FDA recently approved a rapid HIV diagnostic test kit that provides results in as little as 20 minutes. Using a finger stick blood sample, this new test can quickly and reliably detect antibodies to HIV-1 with greater than 99.6% accuracy. Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be used outside of traditional laboratory or clinical settings. It's called the AuraQuick Rapid HIV-1 Antibody Test, and it's manufactured by AuraShare Technologies Incorporated. Each year, thousands of HIV-infected people come to public clinics for HIV testing, but they don't come back to get their results. This test will help resolve that problem because it can provide results without a waiting period. It will also help identify pregnant HIV-infected women who are going into labor, but were not tested during pregnancy, so the steps can be taken to block their newborns from being infected with HIV. To perform the test, a finger stick sample of blood is collected from an individual and transferred to a vial where it's mixed with a developing solution. The test device, which resembles a dipstick, is then inserted into the vial. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device. Two points to keep in mind. First, as with all screening tests for HIV, if the AuraQuick test gives a preliminary positive result, this must be confirmed with a more specific test. And second, the AuraQuick test has not been approved to screen blood donors. The FDA has recently approved a device for women seeking permanent sterilization that's implanted transvaginally in the fallopian tubes and doesn't require an incision or general anesthesia. The product is the Assure system manufactured by Conceptus Incorporated. During the procedure, one of the metal implants is inserted into each fallopian tube using a special catheter that's guided through the vagina into the uterus and then into the fallopian tube. The scar tissue later forms over the implant, blocking the fallopian tube and preventing fertilization. For the first three months after implantation, the patient must use an alternate form of contraception. At three months, she undergoes a hysterosalpingogram to determine if the fallopian tubes are fully blocked. Once blockage has been confirmed, she can discontinue the alternate form of contraception. The approval decision was based primarily on two clinical studies of several hundred women. One of them followed women for 12 months and the other for at least 24 months. To date, none of the women in either study have reported pregnancy and there were no serious adverse events reported. During one of the studies, physicians could not properly position both implants on their first attempt in 14% of the patients. The manufacturer will continue to study the placement failure rate and will also study long-term effectiveness for at least five years. Women should be aware that this procedure is irreversible, but they should also be aware that they could become pregnant after the procedure even many years later and that these pregnancies are more likely to be ectopic. Occasionally on this program, we'll alert you to the existence of counterfeit medical products. This time, we're talking about the counterfeiting of ProCrit, marketed by Orthobiotec Products LP. ProCrit is used primarily to treat anemia associated with chemotherapy, chronic renal failure, and AZT treatment. It's also used in some patients undergoing elective surgery. Other products similar to ProCrit have also been counterfeited. In a letter to healthcare professionals, Orthobiotec said that the counterfeit product comes in four-pack boxes and it's labeled as 40,000 units per milliliter ProCrit. The company stated that the implicated vials appear to be intact and they contain a clear liquid with some active ingredient. But Orthobiotec says that counterfeiters may be acquiring 2,000 units per milliliter vials and relabeling them with counterfeit ProCrit labels that say 40,000 units per milliliter. And so it's possible that patients could be underdosed as a result of this mislabeling. In addition, other potential health risks can't be ruled out at this time. Orthobiotec says that three lot numbers have been implicated to date. These lot numbers appear on your screen and can also be found on our website. Authentic ProCrit was also distributed under these lot numbers. But Orthobiotec's letter points out that based on historical usage patterns and inventory practices, it's likely that all authentic ProCrit with these lot numbers has already been used. So the company says that any product that still has these lot numbers should be considered suspect and not used. Orthobiotec has noted that there are a few subtle differences between the features of the authentic and the counterfeit ProCrit. For example, some of the printing on the counterfeit box wraps around the corner of the panel, leaving no space between the printing and the edge of the box. Authentic ProCrit has a space between the printing and the edge of the box. Orthobiotec has also begun to use color-shifting seals on ProCrit cartons to make possible tampering more evident. Seals will shift color from green to silver when viewed at different angles. If you receive any product that you suspect is counterfeit, do not use it. Store it properly and promptly contact the FDA. Be sure to go to our website for more complete information on how to identify this counterfeit product. Now for a product recall. Tri-State Hospital Supply Corporation is recalling certain kits that contain oral swabs. The kits are called Centurion Mouthcare kits. And the reason for the recall is that the sponges on the end of the swabs may come off the handle and could choke the patient. These swabs are also sold under the SHIELD Health Care Center label as part of enteral feeding kits. These swabs are often used on very elderly or debilitated patients whose gag responses may be so weak that they can't cough up the sponge if it lodges in their throat. In fact, this recall was initiated after a sponge came off the swab handle and obstructed a patient's airway. These kits were distributed to hospitals nationwide after April 1, 2002. Patients may also have taken them home from a hospital or a hospice and so they still may have them. Tri-State is urging these patients to destroy the product because of the potential choking hazard. Go to our website for more complete information including the reorder numbers of the affected kits. FDA and Pharmacia are advising health care professionals about new warnings in the product labeling for the drug Bextra. Bextra is an NSAID used to treat osteoarthritis, rheumatoid arthritis, and dysmenorrhea. Its generic name is Valdecoxib. Since its introduction, this drug has been associated with serious skin and hypersensitivity reactions. These reactions occurred in patients with and without a history of allergy to sulfa-containing products. Although these adverse events are rare, some of the patients required hospitalization. Based on these reports, FDA has approved labeling changes that include a warning for serious skin reactions. The labeling also states that the drug is contraindicated in patients who are allergic to sulfonamides. Since these reactions can be life-threatening, Bextra should be discontinued at the first appearance of a skin rash or other signs of hypersensitivity. 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 at its labeled dose. 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. The Institute for Safe Medication practices has issued an alert about methotrexate overdoses that occur when this drug is accidentally taken daily rather than weekly as intended. The use of methotrexate is well-established in oncology. It's also prescribed in low doses for immunomodulation in such conditions as rheumatoid arthritis, asthma, and inflammatory bowel disease. When it's used for these purposes, the dose is administered weekly or twice a week as opposed to the daily doses that physicians and patients are more accustomed to. This has led to serious and sometimes fatal mistakes. For example, in one case, a physician prescribed methotrexate 15 milligrams daily rather than weekly for a 79-year-old patient. The patient received nine doses before the error was discovered and the patient later died. Another patient died after he misread the directions on a prescription bottle and took 10 milligrams every morning instead of every Monday. Because of the number of fatalities from errors with oral methotrexate, it should be considered a high alert medication regardless of the indication. Here are some of ISMP's recommendations to help reduce the risk of an error. Since oral methotrexate can be prescribed daily in oncology, prescribers should include the clinical indication within the prescription directions. That way, if daily dosing is ordered for an autoimmune disease, the pharmacist will be alert to the possibility of error. If the indication isn't included in the order or the prescription directions, the pharmacist should speak directly with the prescriber to determine the reason for use of methotrexate and to verify the proper dosing schedule. Electronic prescribing systems and pharmacy computers should have built-in alerts to warn clinicians whenever oral methotrexate is entered so that the indication and the dose can be checked. Patients should receive written material that contains clear advice about taking the drug weekly, not daily. The instructions should name a specific day of the week for taking the drug. Avoid choosing Monday since it could be misread as morning. And patients should understand that taking extra doses is dangerous. Encourage feedback to ensure that the patient understands the weekly dosing schedule and that the medication should not be used as needed for symptom control. Now for the part of the program called Patients Are Asking that helps you answer questions about medical products and procedures that are on people's minds. In 2002, a major outbreak of West Nile virus infection occurred in many parts of the U.S. in animals as well as humans. Although the most common means of transmission by far is from mosquito bites, your patients may have heard about cases of people acquiring West Nile virus infections from blood transfusions. They may wonder about whether they could become infected from a transfusion and about the safety of the blood supply. Although investigations are still underway, it's highly likely that the virus can be transmitted by transfusions, although the degree of risk is uncertain. Since about 80% of people infected with the virus will remain asymptomatic, laboratory screening of blood and plasma donors probably will be needed to protect blood safety if the West Nile epidemic continues. There's currently no such test approved and available for donor screening or clinical diagnosis of the virus. But FDA is actively encouraging the development of these tests and we're working with industry to facilitate the development of commercial blood donor screening tests that can be used on a large scale. In the meantime, FDA has developed guidance for blood establishments to help protect the safety of the blood supply against West Nile virus. Because no screening tests are currently available for the virus, this guidance is especially important in answering a number of questions. For example, how should blood establishments decide which potential donors should be deferred? And what should blood establishments tell donors about reporting fever and flu-like symptoms that occur after they donated blood? Be sure that your patients understand two very fundamental things. First, that they cannot acquire the West Nile virus by donating blood. And second, that in situations where a blood transfusion may be life-saving, the benefits of receiving the transfusion outweigh the risk of West Nile virus infection. 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.