 This is FDA Patient Safety News. In this edition, a drug to treat acute hypomobility in Parkinson's patients, a recall of certain minimed insulin infusion sets, a warning about bottles of children's motrin that may contain another drug, and burns in MRI patients wearing transdermal patches. 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 drug APICIN to treat Parkinson's patients during episodes of hypomobility. Those are the so-called off periods when a patient becomes immobile or unable to perform activities of daily living. These hypomobility episodes can occur at the end of a dosing interval with standard background medications, or they can occur at unpredictable times. APICIN is apomorphine, and it's distributed by Birk-Tec Pharmaceuticals. Aren't there other drugs that Parkinson's patients use to help decrease the time they spend in these off periods? There are other drugs, but the difference is that those are used orally over a long period of time where APICIN is used for acute treatment and is given subcutaneously. You said APICIN was apomorphine and apomorphine frequently causes nausea, doesn't it? It does. In fact, apomorphine is an emetic, and that's why this drug should always be given with an anti-emetic drug. But it shouldn't be taken with one class of anti-emetics, the 5-HT3 antagonist, and that includes on-dancetron and similar drugs. Combining APICIN with these drugs can lead to hypotension and loss of consciousness. APICIN can also cause a variety of other side effects, including hallucinations and excessive sleepiness. Let's take a look at our website for more information. Medtronic Minimet is recalling the company's paradigm Quickset Plus insulin infusion sets because of problems that can interrupt insulin flow to the diabetic patients who use them. These problems have included bent cannulas, inclusions in the tubing, leaking at the insertion site and accidental dislodging of the infusion set while removing the insertion device. Serious injuries have occurred as a result, including some hospitalizations. This recall covers all paradigm Quickset Plus models and lot numbers. Patients who have any of these sets should contact the company at 800-MINIMED to get free replacements by overnight delivery. They should stop using the recall sets as soon as they get the replacements. If patients need to continue to use the Quickset Plus sets while waiting for replacements, Medtronic is recommending that they monitor their blood glucose levels frequently and be prepared to inject insulin if necessary. Patients should also contact their health care provider if they experience excessively high or low glucose levels. You can get more information about this recall on our website. Quartus Corporation is cautioning health care professionals about the use of the company's biliary stent, the Precise RX Nitinol Stent Transipatic Biliary System. The Precise RX stents are intended to treat obstructions in the bile duct due to malignancies. FDA has not cleared these stents for use outside the biliary tract. In fact, the stent's current labeling contains a warning that the device's safety and effectiveness in the vascular system have not been established. Nonetheless, some physicians have used these devices in the vascular system. When used this way, air can be introduced into the patient by the stent system, and this can cause serious problems including coma, seizure and stroke. In fact, we've received several reports of malfunction and also of patient injuries due to air embolism when the system is used outside the biliary tract. On May 4th, Quartus sent a notification to their customers describing these severe adverse events and advising them to limit the use of the device to the FDA-cleared uses only. You can find more information on our website. McNeil Consumer and Specialty Pharmaceuticals has issued an alert about a possible mix-up with some bottles of children's motrin-grape-chewable tablets. Instead of containing children's ibuprofen tablets, the bottles might mistakenly contain Tylenol 8-hour gel tabs, which provide an adult dose of acetaminophen. Children who take the Tylenol 8-hour product could receive an overdose of acetaminophen, although no injuries have been reported to date. McNeil says that one manufacturing lot is currently affected. This lot was distributed nationwide to wholesale and retail customers between February 5th and April 1, 2004. Children's Motrin-grape-chewable tablets are round, purple, scored tablets with a non-glossy finish and a grape smell. The Tylenol 8-hour gel tabs are white on one side, red on the other, with 8-hour printed in blue on either the red or the white side. Consumers can identify the lot number by looking on the carton end flap and on the bottle label. Anyone identifying one of the affected bottles should contact McNeil's Consumer Relationship Center at 1-800-962-5357. And parents who think their children may have taken Tylenol 8-hour gel tabs believing that they were children's motrin tablets should contact their health care provider or a poison control center immediately. New risk information will now appear in the labeling for the drug Xelnorm or Tagasarod malleate. This medication is used for the short-term treatment of women with irritable bowel syndrome, whose primary bowel symptom is constipation. The new labeling will contain a warning about the serious consequences of diarrhea in these patients, including hypovolemia, hypotension, and syncope. The labeling also warns that patients on Xelnorm who develop hypotension or a syncope should stop taking the drug, and patients who have or frequently experienced diarrhea should not be started on Xelnorm. The labeling will also contain a new precaution on ischemic colitis in patients receiving Xelnorm. Although a causal relationship hasn't been established, the drug should be discontinued immediately if the patient develops symptoms of ischemic colitis. These include rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. The new information will also be incorporated in a revised leaflet for patients. Go to our website to see the complete labeling. In previous programs, we've talked about several examples of mix-ups between drugs whose names look or sound alike. But here's an example of dangerous mix-ups between two drugs whose packaging looks similar. In a recent article, the Institute for Safe Medication Practices warns about confusing brethine or tributaline sulfate and methylurgonovine malleate. Now, these two drugs have very different pharmacologic actions. I think methylurgon stimulates smooth muscle contraction. Brethine relaxes smooth muscle. That's right. There are pharmacologic opposites. They're frequently used in labor and delivery settings, but for very different clinical reasons. Brethine is used off-label to treat preterm labor, and methylurgon is primarily used after delivery of the placenta to treat uterine atony, subinvolution, or hemorrhage. Methygine should not be used in pregnancy except after the delivery of a newborn. It would be especially dangerous to a patient in preterm labor. So if you mistakenly use one of these drugs for the other, you can do really serious damage both to the mother and to the child. That's right. In one reported case, a patient in preterm labor was given four doses of methylurgon, and it's thought that that contributed to the death of the fetus. Now, you mentioned that the mix-up was because of the fact that they looked alike. How alike are they? Well, they're remarkably similar. Both of these products are packaged as 1 milliliter ampules in an amber plastic tube. The tube is covered by a foil label with the product name in tiny print, making them difficult to tell apart. Both ampules also have similar colored rings around the ampule necks, and that adds to their similarity. So what does ISCP say to do about this problem? Well, they say to keep staff informed about the possibility of errors and to store the product separately. But isn't the messaging kept in the refrigerator? I mean, that would separate them to begin with, wouldn't it? Well, it is supposed to be kept refrigerated, and that should help keep these products apart. But errors are still possible, so ISCP suggests using reminder labels on the ampules to help prevent mix-ups. We've reported before about the dangerous overdoses that can occur with patient-controlled analgesia, or PCA, when the drug is administered by people other than the patient. This hazardous practice is called PCA by proxy. Those who might push the patient's PCA button and thus cause an overdose include well-meaning family members, visitors, and sometimes even the clinical staff. The problem continues to occur, as pointed out by a recent FDA article in Nursing 2004. It describes a case where a nurse awakened a patient to assess pain and, based on the patient's response, pushed the PCA button. The patient eventually became unresponsive and died. The article points out that although PCA pumps include dose and time limits, and that prevents over-medication, patient participation is crucial to maintain safety. If the patient is sleeping or over-sedated, he or she won't push the button, so additional medication isn't delivered. But in this case, the nurse overrode the patient's control of the medication by pushing the button herself and administering more of the analgesic. The article offers several suggestions to help prevent these kinds of occurrences. For example, place warning labels that say for patient use only on PCA buttons or equipment. And remind patients and visitors that the PCA button is to be used only by the patient. Tell visitors that they shouldn't push the button even if the patient asks. And tell them to notify a nurse if the patient seems overly sleepy. Our original story on PCA has more recommendations on how to use PCA safely, and several articles by the Institute for Safe Medication Practices go into greater detail on patient selection, patient monitoring, selecting a PCA pump, programming the pump, preventing PCA prescription errors, and other aspects of the problem. All this information by going to this story on our website. In a recent article, the Institute for Safe Medication Practices talks about a hazard that many people may not know about. Transdermal medication patches, like those that deliver nicotine, testosterone, and nitroglycerin, can cause burns if a patient wears one during an MRI procedure. That's because some transdermal patches have an aluminized backing. The backing isn't ferromagnetic and so it's not attracted to the magnetic field of an MRI system. However, this metallic component conducts heat and so it can cause burns. We've recently received reports of patients wearing nicotine transdermal patches who were burned during an MRI exam. In one case, a patient entered an MRI scanner wearing a Habitrol 21 milligram patch. He started thrashing when the third scanning cycle started and the test was stopped immediately. The patient reported that his arm was burning and there was a small denuded blister where the patch had been. In another report, a patient had a short MRI of the lumbar spine while wearing a nicotine transdermal patch and later the patient complained of burn lines on his upper arms. Here's ISMP's recommendation. Before MRI exams, ask all patients whether they use any medication patch. Unless you're sure the patch doesn't contain metal, tell the patient to remove it temporarily in order to avoid possible burns. In a recent issue of its monthly publication, CapsLink, the USP Center for the Advancement of Patient Safety cautioned that it's especially important to avoid errors when using oncolytic drugs. Most of these drugs have a narrow therapeutic index and they're toxic even at their recommended dosage so that serious patient harm can occur as a result of medication errors. The USP analyzed nearly 4,000 reports of errors with oncolytic drugs reported through its MedMarx program. They found that the most common types of errors were giving the wrong dose, mistakes in prescribing the drug, giving the drug at the wrong time or not at all, and using unauthorized drugs. The USP cites a case in which pachylataxyl was ordered at a dose of 375 milligrams per square meter to treat metastatic breast cancer. Although the correct dose is 175 milligrams per square meter, neither the pharmacist nor the nurse questioned the dosage. The patient developed neutropenia, fever, and sepsis. This is a good example of the narrow therapeutic index with these drugs. Hematological toxicity from pachylataxyl begins to increase at doses above 190 milligrams per square meter, which is only about 10% higher than the correct dose. The USP lists a number of recommendations to decrease the likelihood of errors with oncolytic drugs. Here are just a few of them. First, include oncolytics on your list of high-risk, high-alert medications. Use standardized pre-printed order forms for commonly used chemotherapy regimens or computerized prescriber order entry systems. Don't permit verbal orders for these drugs. Don't use abbreviations, acronyms, or nicknames when prescribing these drugs, and establish a list of required elements in order, including specific information about the patient. And review the oncolytic drugs in your formulary to assess the possibility of errors due to look-alike products. You can find the complete article with all of the USP's recommendations on 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 and 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 US Food and Drug Administration, I'm Mark Barnett. And I'm Anita Rayner. See you next time.