 This is FDA Patient Safety News. In this edition, a new product to correct facial wasting in HIV-AIDS patients, a recall of certain software for metronic and planted infusion pumps, avoiding fatalities during blood transfusions, and clearing up some confusion about kaopectate labeling. 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 Rainer. Let's start with some medical products FDA recently approved. FDA recently approved the first injectable filler that's used to correct facial wasting in people with HIV-AIDS. The condition called lipoatrophy is caused by subcutaneous fat loss, and that results in a sinking of the cheeks and the eyes and the temples. The new product called Sculptra contains polyelactic acid, a synthetic polymer from the alpha-hydroxy acid family. It's manufactured by dermic laboratories. Sculptra is injected into the deep dermis or the subcutaneous layer around the area of fat loss in the face. The effect can take several weeks to become evident, and three to six treatment sessions may be needed to achieve the desired result. The treatment can last up to two years. Touch-up treatments may be needed from time to time to maintain the effect. Sculptra should be injected by health professionals who are expert in correcting volume deficiencies in HIV-AIDS patients. They should avoid injecting the product into the superficial layers of the skin and take special care when they're injecting into areas where the skin is thin. The most common adverse events have been hematoma, bruising, discomfort, inflammation, and edema. The long-term safety and effectiveness of Sculptra haven't been investigated yet, and so FDA is requiring the manufacturer to conduct a study to evaluate safety and effectiveness beyond two years. Medtronic is recalling certain software application cards. They're used in the company's Model 8840 Envision Clinician Programmers. These handheld devices are used to program a number of implantable devices, including the Synchromed and Synchromed EL implantable infusion pumps. The recall is prompted by reports of data entry errors that have led to serious drug overdoses, including two patient deaths. The overdoses occurred when clinicians who were programming the pump entered the wrong time duration or the wrong interval. For example, mistakenly putting the time interval between periodic drug boluses in the minutes field instead of the hours field. The recalled software may have contributed to these errors because one part of the screen did not have labels on the fields for hours and minutes and seconds. Medtronic is now distributing replacement software that adds time labels to the screen to help reduce the risk of these kinds of programming errors. If you use the Model 8840 Envision Programmer with Synchromed or Synchromed EL infusion pumps, the company says you should pay particular attention to selecting the appropriate time field when entering time duration or time intervals. You should also be sure to check your software application card for your Envision Programmer. If you have the older software version, that's AAA02, Medtronic says you should order the newer version, which is AAD02. Go to our website for more information on this recall and for instructions on how to contact the company. Boston Scientific has sent a safety alert to health professionals about the use of Enterix, which is a permanently implanted product that's used to treat patients with GERD symptoms. It's a liquid copolymer that's injected endoscopically into the muscle layer of the lower esophageal sphincter to help prevent acid reflux. The alert describes the death of a patient who had been treated with Enterix three weeks earlier. During the procedure, the needle may have penetrated the patient's esophageal wall. The cause of death is believed to be hemorrhage. Autopsy results indicated a fistula from the aorta to the esophagus and inflammation and evidence of Enterix material in the superficial layer of the aorta. The letter reinforces the importance of closely following the product directions for use and it reiterates the following points on proper injection technique. First, the Enterix solution should only be injected at or just below the squamo-columner junction. The needle should be inserted into the muscle of the esophagus with the needle angled towards the stomach and fluoroscopy should always be used during the injection to help identify a possible transmural injection. The firm will also be updating the product labeling with a warning statement and additional recommendations for close patient follow-up in cases of transmural injection or suspected transmural injection. You can find a copy of Boston Scientific's letter on our website. In a previous program, we reported on the importance of looking out for a potentially fatal condition called trally or transfusion-related acute lung injury in patients who've recently received a transfusion. We now know that in the year 2003, trally was the most frequent cause of transfusion-related deaths and so this is a good time to remind people of how important it is to recognize and treat trally promptly. Trally is caused by an antigen antibody reaction. Well, it is but it's not what you'd expect in a typical allergic reaction. In an allergy, the patient's own antibodies are reacting to a foreign antigen and trally, the antibodies come from the blood donor. In other words, they're in the transfused blood that the patient receives and these are antibodies to human leukocytes and once they're received by the patient through the transfusion, they attach to the patient's white blood cells and form micro-aggregates that end up in the lungs where they can cause life-threatening vascular permeability and pulmonary edema. Some blood donors are more likely to carry these antibodies. That's true when it comes to trally, not all blood donors are created equal. Women who've had multiple births and people who've received previous transfusions are thought to be more likely to have these antibodies. You mentioned how important it is to recognize trally in patients who've recently received a transfusion. What should you be looking for? Well, you'd look for what you'd expect to see if there were an antigen antibody reaction in the lungs. So you'd watch for shortness of breath, hypoxemia, hypotension, fever, and severe bilateral pulmonary edema and those things usually begin within one to two hours after the transfusion and they're fully present within six hours. Depending on the severity of the symptoms, patients may require respiratory support. By the way, diuretics are not effective in treating trally since the underlying pathology involves microvascular injury, not fluid overload. So what should people do? Well, there are three keywords here. It's vigilance, prompt treatment, and reporting. First, be alert that any respiratory distress experienced by a patient during or following a transfusion could potentially be trally. If you observe respiratory distress, discontinue the transfusion immediately and begin oxygen and supportive therapy. Second, notify your transfusion service. They'll arrange for any remaining product to be returned to the blood collecting facility and for the donor to be tested for the antibodies. And finally, report any cases of trally to the FDA. You can find out how to do that by going to our website. Determining the dose of medication to give a child in an emergency can be a challenge. In most cases, the dose is based on the child's weight and this can be very difficult to estimate. Even parents can be far off the mark when they're asked about their child's weight. And even if the estimate is accurate, there's the added chore of looking up the dose for a child of that weight. Some clinicians avoid these difficulties by using a braslow tape, which measures the child from head to toe and uses this measurement to estimate the child's weight and thus the dose. The tape is divided into color-coded segments based on the child's length and each of the colored segments shows the approximate weight for that length child, along with the dose for commonly used emergency drugs for children of that weight. But errors are often made using braslow tapes. In a recent medication safety alert, the Institute for Safe Medication Practices notes that the tapes can be placed alongside the child upside down, which would give the wrong length for the child and thus the wrong dose. ISMP also says that the 1998 edition of the tape can be confusing in several respects and that some of these problems were corrected in the newer 2002 version. They also point out that errors can occur if physicians wrongly assume that the listings of drugs on the tape means that they're to be given in sequence. Here are some of the measures ISMP recommends to prevent errors when using braslow tapes. First of all, replace outdated braslow tapes with the most recent edition that was issued in 2002. To prevent using the tapes upside down, hang them with the red arrow that says measure from this end at the top. Teach the staff to remember red to head when placing the tape alongside the child's body. And if the tape is laminated in plastic, be sure that the plastic doesn't extend beyond the red arrow because that could change the measurement starting point. You'll find the full ISMP safety alert on our website. And if you're interested in providing in-service training on how to properly use braslow tapes, you should know that the Duke University Medical Center has a comprehensive programed instruction course under its program for enhancing pediatric safety. You'll find a link to this program on our website. Which of the following products does FDA regulate? Home pregnancy tests, X-ray machines, implantable defibrillators, contact lenses, catheters, or all of the above? FDA regulates all of them as medical devices. In fact, FDA regulates nearly 2,000 kinds of medical devices. If a medical product is used in your facility and it's not a drug, it's not a vaccine, and it's not a blood product, it's probably a medical device. Recent articles by FDA staff and the USP point out how reformulations of kaopectate, the commonly used OTC anti-diaryl, may be confusing for patients. Many years ago, kaopectate was made with kaolin and pectin. Since then, two changes in the formulation of kaopectate have been necessary because of changes in FDA regulations. About 15 years ago, the product was reformulated to contain adipolgite. And then in 2003, it was modified again to contain business sub-soliculate as the active ingredient. So what's the source of the confusion? Well, first off, supplies of kaopectate that contain adipolgite will remain on store shelves until they're sold. So the patient may be faced with two products of two formulations of kaopectate, one without a polgite and one without. What's the problem? Why is there a concern about this? Well, most of the concern has to do with the fact that the newest formulation, the one that's labeled new and improved, contains a salicylate. And like aspirin, business sub-soliculate products have the potential for many drug-to-drug and drug-to-disease interactions. And in particular, salicylates are not generally recommended for children because of the risk of RISE syndrome, salicylate allergies, and salicylate overdose. So does the label now say, give instructions for using it in children or not? Well, there's more to the confusion. When the product was reformulated in 2003 with business sub-soliculate, the dosing instructions on the label included children. But just this year, FDA said that anti-diarrheals containing business sub-soliculate can only be labeled for use by adults and children 12 years and older. So the most recent version of the Kaopectate label doesn't have the pediatric dosing information at all. So there can now be three versions of this product out there, the old one without a pull guide, then two versions with business sub-soliculate, one of them that has dosing instructions for children under 12, and one of them that doesn't. That's right, and there is a salicylate warning statement that is on the label now, but it could be easily overlooked. So a consumer who doesn't know about the reformulation could unknowingly ingest a salicylate containing product or give it to a child, particularly because some of the new and improved Kaopectate bottles on the shelf may have pediatric dosing information on the label. Well, and other than making patients more aware of the difference between these formulations, what else can be done to kind of minimize the confusion? FDA suggests that pharmacists physically separate the different formulations to help to minimize the confusion for consumers. They also suggest using shelf talkers or some other visual aid to alert consumers about the change in ingredient. Also, advise patients not to remove the peel-up label from the back panel, which contains all the drug facts. Without this label, important information such as drug warnings, dosing directions, and detailed salicylate warnings could be lost. 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. I'm Anita Rayner. See you next time.