 This is FDA Patient Safety News. In this edition, a new use for taxateer in treating prostate cancer, precautions on prescribing crestor, mix-ups between different forms of sodium hyaluronate, and a warning for lactating women about the drug Domperidone. 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 has approved injectable taxateer or dosataxel in combination with prednisone for the treatment of advanced hormone refractory metastatic prostate cancer. Taxateer inhibits the protein tubulin, which is essential to cell division. This is the first drug approved for hormone refractory prostate cancer that's shown a survival benefit. In a randomized clinical trial, those treated with taxateer and prednisone experienced a survival advantage of approximately two and a half months compared with those treated with mitazantrone and prednisone. The most common adverse events reported with the taxateer prednisone combination were nausea, alopecia, and bone marrow suppression. Less common but severe side effects are also possible with taxateer, so be sure to read the complete labeling before prescribing. FDA recently approved the first effective treatment for patients with myelodysplastic syndrome, or MDS, a collection of bone marrow disorders. The drug called VIDASA is asocytidine for injectable suspension and is distributed by Pharmaeon Corporation. VIDASA is believed to be cytotoxic to abnormal hematopoietic cells in the bone marrow, and thus it may restore normal growth and differentiation in the marrow. About 7 to 12,000 new cases of MDS are diagnosed every year. MDS can develop following treatment with drugs or radiation therapy for other diseases, or it can occur idiopathically. Some forms of MDS can progress to acute myeloid leukemia. In clinical studies, which included all subtypes of MDS, about 15% of MDS patients had complete or partial responses to asocytidine. Those who responded to the drug no longer needed transfusions. The most common adverse events reported in clinical trials included nausea, anemia, thrombocytopenia, diarrhea, fatigue, irritation at the injection site, and constipation. In a recent public health advisory, FDA announced that AstraZeneca Pharmaceuticals has revised the European labeling for Crestor or Resuvastatin. The labeling used in Europe will now contain the same precautions about drug-related myopathy as the U.S. labeling. The warning section of the labeling identifies patients who may be at increased risk for myopathy, including those who are over 65, or who have hypothyroidism or renal insufficiency. In announcing the change, FDA is re-emphasizing to U.S. physicians the importance of carefully following the recommendations in the current product label. Here are some of the safety messages in the label. First, base the patient dose on individual cholesterol goals and risks for side effects. Inform patients that statin drugs can cause muscle injury and, in rare, severe cases, kidney damage and other organ failure that can be life-threatening. And tell patients to promptly report muscle pain and weakness, malaise, fever, dark urine, nausea, or vomiting. Bristol Meyers Squibb is notified health care professionals about important drug interactions that can increase or decrease plasma concentrations of the antidepressant drug deseril or trasadone hydrochloride. One type of interaction occurs when deseril is given with CYP3A4 inhibitors such as ketoconazole, endenovir and ratonovir. In these cases, the plasma concentration of trasadone may increase substantially, and patients could experience adverse effects such as nausea, hypotension, and syncope. So if deseril is used with one of these CYP3A4 inhibitors, a lower dose of deseril should be considered. Conversely, the plasma concentration of deseril may decrease when it's given with the anti-seizure drug carbamazepine. So patients who are taking both of these drugs should be closely monitored to see if their doses of deseril need to be increased. Here's a case where we need information from you. In a recent issue of the journal Anesthesiology, an FDA article summarized 34 reports of serious adverse events associated with local anesthetics delivered directly into surgical wounds. They were administered using disposable infusion pumps that are designed for this purpose. These pumps are used to provide local pain relief following a variety of orthopedic, gastrointestinal, OBGYN, and circulatory procedures. The adverse events included tissue necrosis, surgical wound infection, and cellulitis. Well, do we know at this point that it's the procedure that actually caused these adverse events? We don't know, and in fact, these reports by themselves can't establish a causal link between the device or the procedure and these adverse outcomes. Reports like these are called sentinel events, meaning that there are early warnings that a problem may exist. It's also possible that these reports may be nothing more than isolated incidents and that the necrosis and cellulitis could have occurred without the anesthetic infusion. So for not sure, then what are practitioners supposed to do at this point? FDA isn't recommending that they take any direct action at this point, but we are asking practitioners to let us know whether they've seen similar problems with these local anesthetic infusion systems in their own facilities. That will help us determine whether or not these systems represent a real problem. To report to us, just go to our website and click on Report a Problem. Here's some news to pass on to your colleagues in the clinical laboratory. It's about the recall of a multiple-task diagnostic instrument called the TCAN Clinical Workstation, a product of TCAN-US Incorporated. This workstation can be configured with different test systems, including the Roche Diagnostics Amplicore CT-NG test, which is used to detect chlamydia and gonorrhea. Software problems in the TCAN workstation may cause a mismatch among patient samples and test results, which could lead to false-positive and false-negative results. If your laboratory uses this workstation, go to our website for more information about this recall and about how laboratories can help solve the problem. CDC has published a comprehensive report for physicians and other health care professionals on diagnosing and managing foodborne illnesses. It covers how to recognize and treat and report these illnesses, and it features detailed charts with each pathogen, the signs and symptoms of the illness it can cause, the foods that may be implicated, the lab tests that can help with diagnosis, and the treatment options. So this isn't just another pamphlet. It's not another pamphlet. It's about a 30-page document. It's crammed with information, and it should be really helpful in treating patients. And it's free. Go to our website to get a copy. In a recent article, the Institute for Safe Medication Practices pointed out how the keypad design on some IV pumps can lead to dosing errors. ISMP reported on several cases where a nurse had inadvertently pressed the zero instead of the decimal point key when programming a dose, which caused a ten-fold dosing error. These errors occurred because on some IV pumps, the zero and the decimal point keys are located close to each other. If you use pumps with this design, ISMP recommends that you alert staff to the potential for errors. Also, when you're giving high alert medications, be sure to have a second person double-check the program dose. ISMP also points out that using so-called smart pumps that recognize preset dose limits can alert staff to those errors before the infusion begins. In a recent safety alert, the Institute for Safe Medication Practices described a case where a nurse preparing for a cataract procedure went to the refrigerator to get some sodium hyaluronate, which is used in several types of eye surgery. Two brands of sodium hyaluronate were in the refrigerator, and she chose the one called Hyalgan. When the surgeon tried to use it, he noticed that its viscosity was far different from what it should have been. The problem is that Hyalgan is an orthopedic product intended for intraarticular injection and treating osteoarthritis. The sodium hyaluronate the nurse should have chosen is Helan, which is intended for ophthalmic use. So this is a case where two drug products contain the same active ingredient in hyaluronate and hyaluronate and they differ in both physical properties and their uses. ISMP suggests that in facilities where both Hyalgan and Helan are available, this type of mix-up can be prevented by adding auxiliary labels to the drug cartons that say either ophthalmology or orthopedics. The drugs and biologics used in your facility will soon contain barcodes similar to the ones on supermarket products. A recent FDA rule that barcodes appear on all newly approved drugs and biologics and that most existing products are going to have the barcodes within two years. So the main objective here is to help reduce medical errors. It is, and we think that when the program is fully implemented, it's going to have a major impact in cutting down on medical errors. When the barcodes are on all products and when hospitals across the country are using them, nearly half a million adverse events could be avoided and this also should have a beneficial effect on litigation, on malpractice insurance premiums. So from a practical standpoint, how is this type of system supposed to work? Well, it begins when the patient enters the hospital, the ID bracelet will have the barcode on it and that will be linked to the patient's record. Before a nurse administered a drug to the patient, he or she would scan the barcode on the bracelet and that would bring up the patient's medical record on a bedside computer. Then the nurse would scan the drug to be given to the patient. The computer would then compare the drug to the drug orders in the patient's record and if they didn't match, the computer would send the nurse an error message. Well, what kinds of things would cause a computer to send this kind of error message? Well, the most obvious things would be it's the wrong patient or it's the wrong drug but there are other things as well. It could also be the wrong dose, the wrong time to administer the drug or that the prescribed medication to the patient's record. Well, that's for drugs. What about blood products? It seems like that kind of system could help reduce transfusion errors. It would and as a matter of fact barcodes are now appearing on a number of blood products already but the new rule will require that machine readable labels appear on all of them and when that happens when you scan the label you're going to get information on the lot number that relates to the donor, of course that should help to reduce transfusion errors. But in order for this kind of system to work a hospital would have to have barcode readers and scanners in patient care areas and most of them don't have that right now. Well, that's right they don't but this requirement for the barcoding is really a step in the right direction. What it means is that hospitals can invest in the equipment knowing that they'll be able to use it to prevent medical errors. Here's a warning to pass on to patients we've received numerous reports of pharmacies compounding the drug Domperidone and of lactating women using the drug to try to increase their milk production. But Domperidone isn't approved for that indication. That's right it's not approved for any indication in this country and it's also not approved in any country for increasing breast milk production. It has been approved in several foreign countries but only to treat certain gastric disorders. So where are US women getting the drug? Well in this country they're getting the drug from compounding pharmacies and online from foreign sources. Why is the FDA concerned about they're taking the drug? Because women who take this drug may be risking their health. There are reports of cardiac arrhythmias, cardiac arrest and sudden death in patients receiving an IV form of the drug and in fact that form is no longer marketed. At high oral doses seizures and other neurologic side effects have been reported and those are the doses that have been suggested for breastfeeding women. In addition using certain other drugs such as erythromycin could raise blood levels of Domperidone even further and increase the possibility of serious adverse effects. In several countries where the oral form of Domperidone is marketed the drugs labeling specifically warns that nursing mothers should not use it. You've been talking about risk to the mother but what about risk to the infant? That's possible too and it's reflected in the labeling in many countries where this drug is approved for other purposes. The labeling notes that the drug is excreted in breast milk and that could expose a breastfeeding infant to unknown risks. The bottom line is to advise your patients who are breastfeeding not to use Domperidone to try to increase their milk supply. 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.