 This is FDA Patient Safety News. In this edition, a new stint to treat stenosis in the carotid artery, a caution about the importance of adjusting the dose of lovinox in patients with severe renal impairment, a new warning about serious hematologic and neurological events in patients on remicades, and a warning about causing fires with ethyl chloride spray. 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 some medical products FDA recently approved. The FDA recently approved the first stint system that's designed to treat stenosis in the carotid artery. It's called the Acculink Carotid Stint System and it's manufactured by Guyden Corporation. A stint, which is inserted during angioplasty, holds the carotid artery open. It's used with an umbrella-like filter called the Accunet that's designed to open up inside the vessel and catch emboli and other debris that might otherwise travel to the brain and trigger a stroke. In a clinical study, the stint system successfully opened blockages in 92 percent of 581 patients who received the device. The risk of death, stroke, and heart attack at 30 days or stroke in the area of the blockage at one year was about 10 percent in stint patients compared to 15 percent in patients who had surgery. In practice, the Accunet filter is inserted into a vessel in the groin and advanced to the site of the carotid blockage. The filter then opens to catch any debris. An angioplasty balloon is dilated to open the blockage. The stint is then threaded up to the blockage and when it's in place, the stint emerges from the catheter and opens automatically. Another balloon catheter is positioned inside the stint and debris is captured by the filter. The catheter is withdrawn and another one is inserted to close the filter and remove it along with any collected debris. The new stint system is designed for patients who need carotid revascularization but are at high risk from surgical endarterectomy. Patients for the stinting procedure must have at least a 50 percent synosis along with neurological symptoms or if they have no neurological symptoms, they must have at least an 80 percent synosis. Patients who should not receive this device include those who can't tolerate anti-coagulant or anti-platelet therapy, those with vascular anatomy that would preclude the safe introduction of a stint, and those with uncorrected bleeding disorders. FDA recently approved the first drug indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy. The drug is called Simbalta or deloxatine hydrochloride and it's made by Eli Lillian Company. Simbalta, an SSNRI, was also recently approved to treat major depressive disorder in adults. Peripheral neuropathy is the most common complication of diabetes mellitus affecting up to 62 percent of American diabetics. It's usually associated with long-standing diabetes or poor glucose control and it's usually characterized by burning, tingling and numbing sensations that begin in the feet and later affect the legs or hands. Although the mechanism of action is unknown, in clinical trials patients treated with Simbalta reported a greater decrease in pain than those treated with placebo. In these trials, 51 percent of patients treated with Simbalta reported at least a 30 percent sustained reduction in pain as compared to 31 percent of placebo patients. The most commonly reported side effects were nausea, somnolence, dizziness, decreased appetite and constipation. Simbalta is contraindicated in patients with uncontrolled narrow-angle glaucoma and those taking MAO inhibitors. The FDA recently cleared for marketing a new screening test for newborns that will help detect a variety of inborn errors of metabolism. The test is called the Neogram Amino Acids and Acil Carnitine's Tandem Mass Spectrometry Kit and it's manufactured by Perkin Elmer Life and Analytical Sciences. The test starts with a heel stick blood sample from the infant, the same kind of heel stick sample that's already being used for other newborn screening tests required by various states. It applies mass spectrometry to the sample in order to measure amino acids, free carnitine and Acil Carnitine's. Abnormal patterns of these substances may indicate a wide variety of disease states including phenylketonuria, maple syrup urine disease and homocystinuria. While each of these conditions is relatively rare, taken together they're fairly common and they can cause developmental delay, seizures, mental retardation and death. With early identification, many of the effects of these diseases can be mitigated with improved long term outcome and quality of life. This product is not a standalone test for predicting inborn errors of metabolism, rather it's a screening tool that must be used along with clinical information and other tools to determine a newborn's risk. Aventus Pharmaceuticals has revised the labeling for the anticoagulant drug lovinox or anoxaparinsodium injection, stressing the need to adjust the dose in patients with severe renal impairment. That is those with a creatinine clearance of less than 30 milliliters per minute. These patients don't clear and eliminate the drug normally and so they may require a lower dose to prevent bleeding. The label notes that low weight patients and those with mild or moderate renal impairment don't require a specific dose of adjustment, but that low weight patients on the drug should be carefully monitored for bleeding. The label also contains a black box warning that cautions that patients on anticoagulant drugs who receive epidural or spinal anesthesia or who receive a spinal puncture are at risk of developing an epidural or spinal hematoma and that can result in long term or permanent paralysis. The black box warns that these patients should be frequently monitored for signs of neurological impairment and if neurologic compromise is noted urgent treatment is needed. It also recommends that physicians consider benefits versus risks before they decide on neroaxial intervention in patients who are receiving or will receive anticoagulant drugs. In randomized active controlled studies in patients with metastatic colorectal cancer the risks of a serious arterial thrombotic event was about 5% in patients who received a vast and along with 5FU based chemotherapy that's twice as high as the rate in patients who receive the 5FU regimen alone. Patients who are 65 years and older or who have a history of arterial thromboembolism are at higher risk for these events. The company says that patients who experience an arterial thromboembolic event or in treatment should permanently discontinue of Aston. Santicore Incorporated has notified healthcare professionals about new warnings for remicade or infliximab, a drug used to treat rheumatoid arthritis and Crohn's disease. The new safety information describes both hematologic and neurologic events that have occurred in patients being treated with remicade. The hematologic events, some of them fatal, have included leukopenia, neutropenia, thrombocytopenia and pansytopenia. Although it's not clear that remicade therapy causes these events and no high risk groups have been identified, Santicore advises practitioners to be cautious with patients who have significant hematologic abnormalities or a history of these problems. The company also says that all patients on remicade should be told to seek immediate medical attention if they develop signs suggestive of blood discrasies or infection such as persistent fever, bruising or bleeding. Practitioners should consider discontinuing remicade therapy in patients who develop significant hematologic abnormalities. The neurological events have included rare cases of a central nervous system manifestation of systemic vasculitis. Again, practitioners should consider discontinuing remicade in patients who develop significant CNS reactions. The Institute for Safe Medication practice has recently highlighted the dangers of using flammable medical products around heat sources. ISMP has cited cases where fires occurred because practitioners didn't realize that ethyl chloride spray, a topical skin anesthetic, is highly flammable. Ethyl chloride is the kind of old line medication that some people may just take for granted. It's been around for years. And it's used by a wide variety of people. Physical therapists use it to treat myofascial problems. Pediatrists use it before they do minor foot surgery. Dentists use it to test the vitality of tooth pulp. Athletic coaches and trainers use it for sports injuries. So people may not realize or may not remember that it's flammable. And it actually doesn't take a flame to ignite it. It doesn't. Electrical spark can do it. The static electricity can do it. Electrocotery can do it. In fact, that's what was used in one of the cases that ISMP cites. In this case, a nurse practitioner was preparing to treat a six-year-old child's infected toe. She sprayed his foot with ethyl chloride to numb the area, and then she lanced the area with surgical clotery. As soon as she triggered the clotery device, the entire surgical field went up in flames, and the pad underneath the child's foot ignited. The child's mother, who was holding her son, quickly pulled the child away from the fire, and luckily he wasn't burned. Later, the nurse practitioner admitted that she was unaware that ethyl chloride was very dangerous fire hazard, and it should never be used in the presence of electrical cotery equipment. She also mentioned that she'd observed the physician doing the same procedure previously in another child without any problems. Now, how close does the spray have to get to a possible source of ignition, like a spark or a cotery device, in order for it to ignite? It doesn't have to be too close. ISMP points out that the fumes, the vapors from ethyl chloride are heavier than air, and so they can sink to the floor and then move, and so you can have ignition at some distance source and then have flashback in which the flame comes back to the person using the ethyl chloride spray. So what's ISMP recommending? Well, there are two things. One of them has to do with the people who use the spray, and the other one has to do with the spray itself. First of all, they say make sure that all health care workers know about the dangers of flammable products, such as ethyl chloride, and that they understand the potential for burns when these products are used with a heat source. And second, they suggest that you reevaluate whether you really need each of the flammable products in your facility. ISMP says that there are often safer alternatives, especially for topical anesthetics. For more information on preventing surgical fires, go to our website. In an earlier program, we talked about several cases where a mix-up between tetanus-detheria-toxoid vaccine and tuberculin PPD led to unnecessary treatment. In that situation, both products were manufactured by the same company, Venice Pasteur. Since then, several more of these mix-ups have occurred, and some of them have involved products manufactured by other companies. Overall, we've received reports of over 80 cases of these kinds of mix-ups since 1990. So which of the two products is being used by mistake? Are patients who are supposed to be getting PPD, getting the tetanus-detheria-toxoid instead, or is it the other way around? Well, actually, mistakes are being made both ways. And not only that, sometimes PPD is being mixed up with vaccines other than the TD vaccine. Most of the mix-ups occurred with patients who were supposed to get PPD skin tests, but were inadvertently given intradermal injection of the TD vaccine. In some cases, the reactions from the TD injections were read as positive PPDs, and patients were started on isoniazid. And there are reports of the opposite mix-up occurring, where patients received intramuscular injection of PPD instead of receiving the TD vaccine. We've also gotten reports of similar mix-up errors between PPD skin tests and other vaccines, such as pneumococcal vaccine, flu vaccine, and hepatitis B vaccine. Why are these mix-ups happening? Well, one of the main factors appear to be the way the products are stored. Both the TD vaccine and the PPD require refrigeration, and they're often stored side-by-side. Another factor may be similar product packaging. Both of Venice Pasteur products come in stylized, colorful cartons of the same size. So, okay, what's FDA recommending to try to prevent these kinds of things from happening? Well, of course, the most obvious recommendation would be to carefully read the label before you administer the product, particularly where the packaging may look similar. But there are other things you can do, too. For example, consider storing these products separately. It's also a good idea to prepare only enough product for that particular patient at that particular time. And be sure to keep good records of lot numbers for vaccines and other injectable products. If your facility has barcode scanning technology, scanning the package could help to catch errors when dispensing or administering the product. You can report vaccine PPD mix-ups or send in suggestions on how to prevent such errors by going to our website. 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.