 This is FDA Patient Safety News. In this edition, a story on preventing fatal overdoses when using fentanyl patches, a caution on giving contrast media using power injectors. Why to think twice before using metallic tracheal stents in patients with benign airway disease? 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. Let's start with a medical product FDA recently approved. FDA recently approved a new drug for patients with advanced HIV disease. The drug, called aptivus, or typranovir, is an HIV protease inhibitor. It's intended to be given in combination with retanovir and other antiretroviral drugs to patients who have limited treatment options. Aptivus is made by Borenger-Ingelheim Pharmaceuticals. In clinical trials, aptivus, when used in combination with retanovir and other antiretroviral agents, was shown to be effective in patients who had HIV strains highly resistant to other drugs. The product labeling will carry a boxed warning that aptivus can cause serious liver problems, especially in patients with liver disease. Because of the potential for serious drug interactions, certain drugs are contraindicated in patients taking aptivus plus retanovir. They include certain antiarrhythmics, antihistamines, ergot derivatives, and herbal products. FDA has issued a public health advisory about deaths and serious injuries that have occurred when pain-relieving transdermal patches containing fentanyl, such as diragesic, were misused. This has caused fatal overdoses of the drug. You know, those patches are single-dose. It seems if you used just one patch at a time, it would be pretty difficult to overdose. Well, not necessarily. For example, absorption of the drug can be greatly increased by heat. The Institute for Safe Medication Practices describes an incident where a patient's caregiver placed the fentanyl patch on the patient's buttock, which was the site of her pain. When the patient went to bed, she also used a heating pad at the same place. The patient was discovered dead two days later. According to ISMP, neither the prescribing physician nor the pharmacist had counseled her on how to use the patch properly, and they hadn't told her to avoid applying heat over the patch. Now, there have also been cases where members of the patient's household have gotten into trouble with the patches. That's right. Children have gotten hold of these patches with tragic results. In one case, a mother found her four-year-old son dead next to an overturned trash can that held torn wrappers and used patches. The boy had applied a patch to his body, either a discarded one from the trash, or one he opened from a box of new patches. ISMP also describes a case where a child was accidentally exposed to a patch that fell off a family member, and another one where a child removed his grandmother's patch and applied it to himself. So it seems like from what you said that one important precaution would be keep the patches out of the trash. That's right. And it's important to instruct patients how to safely store and dispose of these patches. Used patches, or those that are no longer needed, should be folded in half so that the sticky side of the patch sticks to itself and then flush down the toilet. And, of course, warn patients to keep the patches out of the reach of children. Now, in the case you described of the woman, it was the heating pad that got her into trouble. That's right. Heating pads can increase the absorption of the drug, but so can any heat source. That includes using electric blankets or taking long, hot baths. A high fever can also increase absorption. And remember that using other CNS depressants, including alcohol, can have an additive effect on a patient using fentanyl. Now, even if you teach patients all the right things, an overdose can occur. What then? Right. The advisory says to counsel patients and their caregivers to recognize the signs of fentanyl overdose. These include trouble breathing, extreme sleepiness, or the inability to think, talk, or walk normally. If these signs occur, patients or their caregivers should get medical help right away. Let's go back to basics and talk about the indications for fentanyl and how that affects safety. Well, that's a good point. It's very important to recognize that the indications for these patches are somewhat limited. The advisory reminds practitioners that these patches should only be used by patients who have chronic pain that's not well controlled with shorter-acting painkillers and who are tolerant to opiates. Fentanyl patches should not be used to treat short-term, intermittent, or post-operative pain. And they should always be prescribed at the lowest dose needed for pain relief. FDA is reminding radiology personnel about the potential for serious patient injury when vascular access devices that are not designed to withstand high pressures are used for power injection of CT or MRI contrast media. We've received over 250 reports over the past few years where vascular access devices have ruptured under high pressure, sometimes causing fragmentation that required surgical intervention. The ruptured devices included central venous catheters, implanted ports, extension tubing, and IV administration sets. Ruptures occurred when the injection pressure is too great for the vascular access device to withstand. To help prevent these ruptures, FDA recommends that radiology personnel check the labeling of each vascular access device for its maximum pressure and flow rate. If this information isn't available, you should assume that the device is not intended for power injection and don't use it for this purpose. If you do know the maximum pressure that the vascular access device can withstand, be sure to adjust your power injector so that it doesn't exceed this limit. It's important to understand that if the recommended pressure for a vascular access device is exceeded, the device could be weakened even though no rupture is evident, and the weakened device could fail to operate properly when it's used again. In our January broadcast, we told you about labeling changes for mithroprex or mitheparastone, also known as RU486, an orally administered drug that's used for the termination of early pregnancy. These labeling changes warrant healthcare practitioners and patients to be on the alert for rare but serious risks, including infection, bleeding, and ectopic pregnancy. FDA has recently announced further labeling changes that describe four deaths from sepsis. They occurred in women who had used mitheparastone with vaginally administered mesoprostol. In two of the cases, the bacterium was identified as claustrandium sordeli. Also, the medication guide for patients now alerts them to seek medical attention if they develop certain symptoms more than 24 hours after taking mesoprostol. They include general malaise, abdominal pain and discomfort, weakness, diarrhea, nausea and vomiting, with or without fever. Go to our website for more information. FDA has issued a public health notification cautioning healthcare professionals about the use of metallic tracheal stents in patients with benign airway disorders. Using metallic stents in these patients may preclude their receiving alternative therapies in the future. According to the notification, complications from the metallic stents have included obstructive granulation tissue, stenosis, stent migration and infection. And removing the stent can result in mucosal tears, severe bleeding, re-obstruction and respiratory failure. The notification recommends that metallic tracheal stents not be used in patients with benign airway disorders until all other treatment options, such as surgical procedures or silicone stents, have been explored. Also, using metallic stents as a bridge to other therapies is not recommended because removing the stent can cause serious complications. If a metallic tracheal stent is the only option for the patient, the notification says that it should be inserted by a physician who's trained or experienced in metallic tracheal stent procedures. And likewise, if it's necessary to remove the stent, this should be done by a trained or experienced physician. Genentech has notified healthcare professionals about serious blood-related disorders and infections that have been associated with the drug Reptiva, or ephelizumab, which is used to treat certain patients with plaque psoriasis. The labeling for Reptiva now warns about immune-mediated hemolytic anemia, which can become apparent several months after starting treatment, and it caution prescribers to discontinue the drug if this occurs. The new labeling also includes expanded warnings about serious infections and thrombocytopenia that have been associated with Reptiva. Parago Company has recalled certain oral drops for infants because they're packaged with a dosing syringe that could lead to improper dosing for infants under two years old, including overdosing. Parago makes OTC products sold under many different store-brand names, including Target, CVS, and Walgreens. The recalled drops are for pain, coughs, and colds. The problem is that the oral dosing syringe has only one marking at 1.6 milliliters. That's the right dose for children two to three years old who weigh 24 to 35 pounds. However, these drops are also intended for children younger than two years old who weigh less than 24 pounds. And for these younger children, the labeling directs consumers to ask a doctor for dosing directions. But even if the consumer knew their correct dose for these younger children, the syringe isn't marked to deliver it. The affected products are cherry and grape flavor infant pain reliever, 160 milligram acetaminophen, cherry flavor cough and cold infant drops, and cherry flavor decongestant and cough infant drops. These products were sold nationally through several dozen retail chains and grocery stores under the store-brand names. Parents who want to use these products for children under two years old should discuss how to determine and measure the proper dose for their doctor. You can find more information about the affected products on our website. Each year, more than 2 million patients in this country undergo laparoscopic procedures, ranging from cholestectomies to sterilization. During these procedures, trocars or access ports are inserted into the abdominal cavity to allow entry of the laparoscopic instruments. Well, although the vast majority of these surgeries are performed safely, it is possible to cause a life-threatening injury when inserting a trocar. In fact, between 1997 and mid-2002, FDA received more than 1,300 injury reports, including approximately 30 deaths. Complications most likely to result in death included vascular injury and infection, secondary to bowel injury. FDA recently issued a report on patient injuries from trocars used during laparoscopic surgery. It's based on FDA adverse event reports, published literature, product recalls, trocar labeling, and patient educational brochures, and it outlines recommendations to prevent patient injuries. You can get a copy of the complete report by going to our website. In 2003, we told you about an FDA advisory on the potential neurologic toxicity of lindane, a topical second-line treatment for scabies and lice. We noted the importance of limiting the use of lindane to just one application. The advisory specified that lindane must be dispensed only in single-use containers of one or two ounces, and that was intended to reduce the possibility that patients would apply an excess amount of the product or that they'd reapply it. Today we want to tell you about a different kind of problem related to lindane. A recent article in MMWR reported on 870 cases of illness from 1998 to 2003 that were caused by the unintentional ingestion of lindane. In a number of these cases, lindane was mistaken for a liquid oral medication such as cough syrup. The article notes that before the changes in 2003, bottles of bulk lindane were sometimes repackaged by pharmacies into smaller bottles that looked like those used for oral medications like cough syrup, and that could have contributed to the many unintentional ingestions. And because bottles of bulk lindane already in use were not recalled from pharmacies after the 2002 advisory, some repackaging might still be occurring even today. Also, some consumers might still have repackaged lindane in their homes. So although the use of lindane appears to be declining, cases of accidental ingestion are continuing to occur. The article points out several important reminders about the appropriate use and packaging of the product. First, lindane is a second-line therapy for scabies and lice and should be used only if other treatments have failed or are intolerable. It should not be used in children and small adults who weigh less than 110 pounds. Because of the risk of toxicity, lindane treatment should not be repeated. Pharmacists should not transfer lindane to other containers and they should dispense lindane only in the one- or two-ounce single-use containers that are provided by the manufacturer. 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 that 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 Anita Reiner.