 This is FDA Patient Safety News. In this edition, Prozac for Children, a new immunosuppressive treatment for psoriasis, an endoscope manufacturer cautions about proper reprocessing, and advice for pregnant women about ultrasound videos. 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 our new products bulletin board and tell you about some medical products FDA recently cleared for marketing. You can find information on all FDA-cleared medical products on FDA's website. FDA recently approved the use of the Antidepressant Prozac to treat children ages 7 to 17 for major depressive disorder and obsessive compulsive disorder. This is the first time that a selective serotonin reuptake inhibitor has been approved to treat this age group. Prozac had already been approved for major depressive disorder in adults. It's estimated that depression affects up to 2.5% of children and 8% of adolescents in the U.S. Obsessive compulsive disorder affects about 2% of the population, generally beginning during adolescence or early childhood. At least one-third of adult cases of obsessive compulsive disorder begin in childhood. The approval of Prozac for children was based on two placebo-controlled clinical trials. The side effects of the drug in children were similar to those experienced in adults. Mark, wasn't there a question about weight gain and growth? Yeah, there was, as a matter of fact. In one clinical trial, the pediatric patients treated with Prozac gained on the average about a half an inch less in height and about two pounds less in weight after 19 weeks compared with the placebo group. The clinical significance of this finding is unknown at this time. Eli Lilly, the company that markets Prozac, has agreed to perform a post-marketing study to determine any possible effect of the drug on long-term growth in children. In a recent talk paper, FDA announced the approval of a new immunosuppressive treatment for moderate to severe plaque psoriasis. It's called amovive and it's made by Biogen Incorporated. The generic name is oleficept. Psoriasis affects between one and two percent of the U.S. population. Plaque psoriasis is the most common form of the disease and it's characterized by inflamed scaling lesions, pain, and itching. Some patients also experience arthritic changes in the joints. Amovive provides a new option in managing psoriasis patients. Unlike other immunosuppressive agents used to treat this disease, amovive targets memory T cells that enable the body to maintain immunity long after the initial challenge to the immune system. Because of this, the response to amovive tends to be sustained. But this also raises concerns about long-term adverse effects. That's why the labeling for amovive stresses the need to inform patients about the importance of regular monitoring of white blood cell counts during the treatment. The labeling also states that patients should be informed that amovive suppresses their immune systems, which could increase the likelihood of developing infections or malignancies. Because the effect of amovive on the fetal immune system is not known, if a patient becomes pregnant while taking amovive, the practitioner should enroll her in the manufacturer's pregnancy registry. You can find instructions on our website. FDA based its approval of amovive on the results of two randomized double-blind placebo-controlled studies of over a thousand patients. In both studies, a significantly higher percentage of patients receiving amovive showed improvement compared with those receiving the placebo. In another talk paper, FDA announced that a test for glycated hemoglobin is now available over the counter for home use by diabetic patients. The test, A1C Now, is manufactured by Metrica Incorporated and was previously available only by prescription. Glycated hemoglobin is produced in the body when glucose interacts with hemoglobin. Blood levels of this substance are an indicator of long-term glucose levels in the body, and so it's important for diabetic patients to be tested for it every three to four months. In the past, patients generally had to go to a medical facility to have the test done. The new test offers the convenience of immediate results in the patient's home, which may help motivate patients to be tested on schedule. To perform the test, the patient takes a finger-stick blood sample and places it in the single-use monitor that comes with the kit. The results are displayed in eight minutes. FDA cleared the test for non-prescription use based on a clinical study in which nearly 300 patients used the test without supervision and achieved test results comparable to those of medical professionals. FDA recently approved the first drug for osteoporosis that stimulates new bone formation. It's called Forteo, manufactured by Eli Lillian Company, and its generic name is teraparitide. Teraparitide is a portion of human parathyroid hormone, a primary regulator of calcium and phosphate metabolism in the bones. Forteo is indicated for the treatment of osteoporosis in those postmenopausal women who are at high risk for fracture. In men, it's indicated to increase bone mass for those with primary or hypogonadal osteoporosis who are at high risk for fracture. Forteo is administered intramuscularly once a day in the thigh or abdomen. It's important to note that in laboratory studies, the drug was shown to increase the incidence of osteosarcoma in rats. Although no cases of osteosarcoma were reported in human studies, the possibility cannot be ruled out that humans treated with this drug could face a higher risk of developing this type of cancer. Forteo's label includes a black box warning about this potential risk. It's also explained in a medication guide provided to patients each time the drug is dispensed. People with growing bones like children and adolescents and people with an increased baseline risk of osteosarcoma, such as those with Padgett's disease of the bone, should not be treated with Forteo. The drug is also contraindicated in patients with hypercalcemia, women who are pregnant or nursing, and patients who have ever had bone cancers or cancer that has metastasized to the bone. And patients should not be treated with Forteo for more than two years since long-term effects are not currently known. Olympus America Incorporated has learned that some healthcare facilities were not cleaning and disinfecting the Auxiliary Water Channel found on certain 160 series Olympus GI endoscopes because either they may not have realized that the Auxiliary Channel was there or because they didn't use the channel during the endoscopic procedure. Failing to clean and disinfect a water channel could potentially cause cross-infection between patients. This Auxiliary Water Channel, or water jet, is found on five models of Olympus Auxira colonoscopes and one gastroscope. The channel allows the endoscopist to wash the GI mucosa under observation during endoscopy. You can tell whether your Auxira endoscope has an Auxiliary Water Channel by looking for the Auxiliary Water Inlet on the endoscope's light source connector. In February, Olympus sent a safety notice to remind customers that their endoscopes have an Auxiliary Water Channel and they re-emphasized existing instructions on proper reprocessing. Most importantly, Olympus stressed that this channel must be cleaned and disinfected each time the endoscope is used, even if the Auxiliary Water feature isn't used. You can find the safety notice from Olympus on our website. Several years ago, FDA received a number of reports of patients being electrocuted when the electrode lead wires or patient cables attached to their bodies were accidentally inserted into live electrical outlets. To protect patients from these kinds of mix-ups, FDA required that lead wires and cables be protected or shrouded so they can't be inadvertently plugged into electrical outlets. To know, Mark, sometimes solving one problem can create the potential for a different kind of problem. That's right, and that's exactly what happened. There was a case described in a recent FDA article in the journal Nursing 2002 where a patient in the ICU had a temporary transvenous pacing catheter inserted. A problem arose when the catheter pin design was incompatible with the PACER adapter so staff members couldn't connect it to the pulse generator and pacing was delayed for the patient. We've received other reports of equipment incompatibility or difficulty in maintaining the connection between a temporary pacing lead and the pacing generator. The main reason for the problem is that there are different connector designs using temporary pacing systems. They're made by different manufacturers and they may not be compatible. So when you assemble a temporary system with components from more than one manufacturer, they may not fit properly. The solution is to take an inventory of your facility's temporary pacing equipment and identify the type of connector design. Make sure ahead of time that all pacing components are compatible and they fit properly. Remove and replace any incompatible components. Ask the manufacturer of your pacing system if it requires adapters and be sure to get the right one if it does. By doing those things, you'll prevent delays in pacing therapy. The American Academy of Pediatrics and the Agency for Healthcare Research and Quality have announced a partnership to help avoid medical errors in children. They've published a new fact sheet for parents called 20 Tips to Help Prevent Medical Errors in Children. The fact sheet explains that medical errors can occur in the hospital and the doctor's office and even in patients' homes and that the kinds of errors range from diagnostic issues to surgery to medications. It urges parents to be involved in their child's health care and to act as an advocate for their child, speaking up if there are questions or concerns. And it goes on to suggest specific ways to do this. You can find this fact sheet for your patients by going to our website. The Institute for Safe Medication Practice has recently cautioned about writing drug names that end in the letter L. ISMP reported on two overdoses that occurred because the lower case L was the last letter in a drug's name was misread as the number one. In the first case, an order for Tegretol 300 milligrams was misinterpreted as 1300 milligrams. The letter L at the end of Tegretol had been written very close to the 300 on the patient's transfer order form. When a nurse transcribed this medication onto a hospital order form, she misread the dose and wrote an order for Tegretol 1300 milligrams. The pharmacist who processed the order wasn't familiar with the medication, and the pharmacy computer system did not alert him that the dose exceeded safe limits. The patient received only one dose in error before a clinical pharmacist caught the mistake. Fortunately, the patient's Tegretol level had been low, so the dose made him lethargic, but not seriously toxic. In the other case, a nurse misread an order for Amaril 2 milligrams as 12 milligrams, because again, there wasn't enough space between the last letter in the drug name and the numerical dose. But in this case, the pharmacist caught the error before it reached the patient, because the profile on the automated dispensing cabinet stated the dose correctly. Adequate spacing between the drug name and the dose is also crucial on medication history forms, pre-printed order forms, and electronic formats such as the pharmacy computer, computer-generated medication administration records, and computerized order entry systems. True or false? When FDA approves a new medical product for marketing, this assures that it's completely safe. False. FDA does require clinical testing in many cases, but this testing can't always reveal rare adverse effects, the kind that will occur only after the product is in widespread use over a period of time. That's why FDA relies on reports from health professionals to identify new problems and take action. For some time now, certain firms have been offering expectant parents ultrasound videos of their unborn child. The idea is that you have a video that shows your baby before it's born and you keep it alongside videos and snapshots of the child later in life. Anita, what if your patients ask about whether they should have one of these? I mean, it sounds like good, clean fun. But Mark, there's a problem. These procedures could carry some risk. Ultrasound is a form of energy with low levels used in imaging procedures. It can produce physical effects in tissue, such as mechanical vibrations and a slight rise in temperature. We should stress that ultrasound has been used in obstetrics for many years, and to date, there's no evidence that these effects are harmful to the fetus. So the fact that these effects exist means that we can't assume that prenatal ultrasound procedures are completely innocuous. When the ultrasound procedure is performed by a qualified clinician for such things as fetal age, positioning, or abnormalities, the medical benefit far outweighs the risk, if any. But fetuses should not be exposed to ultrasound energy simply to have a video. If your patients ask about whether they should get one of these so-called keepsake videos, you should advise them that it's not a wise decision. 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 Anita Reiner. And I'm Mark Barnett. See you next time.