 This is FDA Patient Safety News. From this edition, an increased risk of suicidality in children treated with stritera, the recall of enterics for treating gastroesophageal reflux disease, a new caution on using paxil during pregnancy, and preventing fatal errors with neuromuscular blocking agents. 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 a new warning about a drug used to treat ADHD. FDA recently alerted health care providers that treatment of children and adolescents with stritera increases the risk of suicidal thinking. Stritera, or atomoxetine, is approved to treat ADHD in patients six years and older. The increased risk of suicidal thinking was identified in a combined analysis of 12 placebo-controlled trials lasting six to 18 weeks. This analysis showed that 0.4% of children treated with stritera reported suicidal thinking compared to no reports in children treated with placebo. A similar analysis in adults treated with stritera for either ADHD or a major depressive disorder found no increased risk of suicidality with the use of the drug. A new boxed warning will point out that children who were started on stritera therapy should be observed closely for suicidal thinking or behaviors, clinical worsening or unusual changes in behavior. This is especially important during the initial months of therapy or when the dose has changed. Families should contact their child's doctor if they observe any of these signs. Eli Lilly, the drug's manufacturer, will also be developing a patient medication guide to provide this information directly to patients and their caregivers. In an earlier edition of FDA Patient Safety News, we told you about a safety alert from the manufacturer of Enterix, which is a product that's used to treat gastroesophageal reflex disease or GERD. Enterix is a liquid copolymer that's injected into the muscle layer of the lower esophageal sphincter. Shortly after injection, it solidifies into a spongy material that acts as a physical barrier to help prevent reflux. Once injected, the material can't be removed. The safety alert cautioned physicians about using proper injection techniques. It cited the death of a patient in whom the injection needle may have penetrated the esophageal wall, injecting the material into the wall of the aorta. And now with more reports of serious adverse events, the manufacturer, Boston Scientific, has recalled all Enterix products. Physicians should stop using Enterix immediately and return unused product to the company. You mentioned the one patient who died after Enterix was injected transpirally through the esophageal wall. What happened in the later cases? There were cases in which the material was injected into the aorta, the mediostinum, and the pleural cavity. And in some cases, this wasn't recognized until several weeks after the injection took place. So, unanticipated problems didn't occur unless the Enterix was injected transpirally? Not necessarily. There were some cases in which the Enterix was not injected transpirally. It stayed within the esophagus. And still, the patient experienced esophageal stenosis. So physicians are supposed to immediately stop using this product. But what about patients who have already received it? If it's suspected that there was transmural injection, then the patient should be carefully monitored for at least 30 days. You want to watch for chest or epigastric pain, flu-like respiratory symptoms, syncope or flank pain. Even if you don't suspect injection outside the esophagus, patients should still be told to keep up with their regularly scheduled appointments and to watch for and report symptoms. If symptoms do occur, X-ray or CT exams should be done to rule out transmural injection. The most important thing to tell patients is to go to an emergency room immediately if they experience chest pain or syncope. FDA and CDC are alerting health care providers and consumers about six reports of Guillain Barre syndrome following administration of Menactra, a meningococcal vaccine manufactured by Sanofi Pasteur. Do we know that the cases of GBS are actually caused by the vaccine? No, we don't. At this point, the information we have is very preliminary. It isn't known whether these cases of GBS were caused by the vaccine or were just coincidental. At the present time, there are no changes in the recommendations for vaccination against meningitis. Now, considering that this vaccine has been given to several million people, six cases of GBS doesn't seem all that unusual. That's right. The number of cases that we know about so far is about what you'd expect in a patient population of this size, even without the vaccine. But the timing of these six events causes some concern. And since vaccine adverse events aren't always reported, there may be additional cases that we don't know about. So FDA and CDC are asking anyone who knows of GBS occurring after Menactra administration to report this to the Vaccine Adverse Event Reporting System. You'll find out how to do this on our website, or you can call 1-800-822-7967. GlaxoSmithKline has notified healthcare professionals that new precautionary information is being added to the labeling for the antidepressant Paxil or peroxidine hydrochloride. The new information summarizes a retrospective epidemic logic study performed by the company. This study suggests that the risk of major congenital malformations in infants born to women who take Paxil during the first trimester may be approximately twice as high as the risk for women taking other antidepressants. The company is recommending that physicians carefully weigh the potential risks and benefits of using Paxil during pregnancy and that they discuss these latest findings along with treatment alternatives with their patients. True or false, MedWatch is a special timepiece used to keep track of when patients take their medications. False, MedWatch is a system that health professionals or consumers can use to report adverse events with medical products to the FDA. ISMP recently issued a safety alert called Paralyzed by Mistakes, which warned about inadvertently giving neuromuscular blocking agents such as pancuronium to patients who aren't receiving ventilator support. This can lead to respiratory arrest. Some patients have died or incurred permanent injuries as a result of these errors. ISMP notes that some of the errors are due to lookalike packaging and labeling. In one case, an ED nurse administered pancuronium instead of flu vaccine because the vials in labeling look very similar. Big drug names have also caused problems. In one case, vancomycin was misread on a faxed medication record as vecuronium. Giving the neuromuscular blocking agent after the patient is extubated has resulted in serious problems too. In one case, an infusion bag of vecuronium was left in a patient's room after ventilator support had been removed. The bag was later mistaken as potassium chloride infusion and administered to the patient. These patient injuries have also been caused by the opposite problem, that is, administering the neuromuscular blocking agent too soon before the patient is intubated. Some errors have resulted from preparing syringes from a multiple-dose vial and neglecting to label them. In one case, an unlabeled syringe of vecuronium ended up in a supply of saline flush syringes and was given to a three-year-old child. With storages and other causes serious mistakes, seven infants in a hospital nursery received atracurium instead of hepatitis vaccine after an anesthesiologist placed a vial of atracurium in the nursery refrigerator near vaccine vials that looked similar. Finally, not knowing enough about the drug's action can also contribute to errors. In one case, a nurse mistakenly administered vecuronium to an oncology patient who was not being ventilated and the patient died. Had the nurse realized that the drug would paralyze the respiratory muscles, the error might have been avoided. ISMP reminds healthcare practitioners that neuromuscular blocking agents are high-alert drugs and should receive your highest attention. Their safety alert suggests 12 ways to prevent these kinds of errors. Here are a few of them. Good access to the drugs, allowing floor stock only in the OR, the ED, and critical care units. Segregate storage, keeping boxes containing these agents separate in refrigerators and on shelves. Place warning labels on vials, syringes, and fusion bags and boxes that say warning. Paralyzing agent causes respiratory arrest. For dispensing and administering these drugs, require an independent double check of the drug against the actual order. And after the patient has been extubated or the drug has been discontinued, promptly isolate vials, syringes, and infusion bags containing the drug in a sequestered bin for pharmacy pickup. You can see all of ISMP's recommendations in more detail on our website. Lower fittings, connectors, and locks are small, inexpensive, and convenient. They're commonly used to connect many medical devices, components, and accessories. Unfortunately, because they're so easy to use, healthcare personnel may mistakenly connect the wrong devices and then deliver a substance through the wrong route. These kinds of errors can cause serious injury or even death. In previous programs, we described incidents where tubing from a portable blood pressure monitor was mistakenly connected to the patient's IV line causing fatal air emboli. In another case, an air supply hose from a pneumatic compression device was inadvertently hooked up to a needleless IV tubing port. A recent FDA article in the journal Nursing 2005 reports on these and other types of misconnections between devices with lower connectors. In one case, while a patient was being repositioned, his IV tubing became disconnected. He was inadvertently reconnected to the inflation port of his tracheal cuff. The IV fluid infused into the cuff causing an acute airway obstruction, and the patient suffered respiratory arrest and died. In another example, a ventilator-dependent patient was receiving enteral nutrition after an aortic aneurysm repair. The enteral nutrition tubing was inadvertently connected to the patient's central line after a diagnostic test was performed. The patient received about 45 milliliters of enteral feeding solution intravenously. The FDA article describes some precautions you can take to help prevent these deadly mix-ups. First, teach staff to carefully inspect and then follow the proper connector sequence when connecting tubing and device components. Read and follow the equipment manufacturer's recommendations and precautions, especially about compatibility with other devices. Don't modify IV or feeding devices because doing so may compromise the safety features built into their design. Consider using devices that are specifically designed for safety to reduce the risk of misconnections. And tell patients and family members that they must ask clinical staff for help when they need to disconnect and reconnect equipment because they could easily connect the wrong devices. Periodically on this program, we point out medication errors that occur when drug names look or sound alike. This time, we're talking about mix-ups between several drugs that all begin with a letter T, toprol-XL, which is a beta blocker, topomax, which is used to treat epilepsy and prevent migraine, and tegritol or tegritol-XR, which is another anti-epileptic. These mix-ups have occurred when prescriptions for these products were poorly written, misinterpreted, or incorrectly labeled or dispensed. Computer selection errors also played a role. In a number of cases, patients suffered adverse events because of these errors, and in some cases they had to be hospitalized. Of course, the similarity between the product names was reported to be a key factor in these errors. Also, these drugs are often stored close to each other on pharmacy shelves. And there's some overlap between the available dosage strengths of these products. The manufacturers of toprol-XL and topomax recently sent letters to health care professionals and pharmacists, alerting them to this name confusion and suggesting ways to reduce the potential for dispensing errors. For example, prescribers should use both brand and generic name, as well as indication when writing prescriptions. Doctors could physically separate the products on stock shelves and use shelf talkers as needed. You can find more ways to reduce these mix-ups 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 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.