 This is FDA Patient Safety News. In this edition, a new black box warning on antidepressants and children, a new caution on osteonecrosis in patients taking bisphosphonates, a recall of certain pulmonetic ventilators that are used in hospitals and at home. 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 an update on an issue we've covered before. In several previous programs, we've talked about the increased risk of suicidal thoughts and behavior in children and adolescents who are being treated with antidepressant medications. FDA recently took several steps to strengthen safeguards for young patients being treated with these drugs. But didn't some of the manufacturers of these antidepressants already change their labeling to reflect this sort of caution? That's right. They did. But one of the major differences is that now a black box warning is required for all antidepressant drugs. And, of course, a black box is the most serious type of warning in prescription drug labeling. The black box describes the increased risk of suicidality in pediatric patients. And it emphasizes the need for closely monitoring patients started on these medications. It also describes what uses the drugs have been approved or not approved for in pediatric patients. It doesn't prohibit the use of the drugs in children and adolescents, but it warns of the risk of suicidality and it encourages prescribers to balance this risk with clinical need. You said that this now applies to all antidepressants, right? That's right. And that's a significant change. The previous warnings applied to the SSRIs and several atypical antidepressants based on analyses of placebo-controlled trials of these particular drugs. The new labeling changes apply to the entire category of antidepressant medications. That's well over 30 drugs. That's because the currently available data are not adequate to exclude antidepressant drug from the increased risk of suicidality. Everything you've talked about so far has to do with the practitioner. But what about the patient and the caregiver? I mean, they've got a role to play, too, in being on guard for this. Right. The new patient medication guide will play a role. A med guide is FDA-approved user-friendly information for patients and it's supposed to be distributed by pharmacists with each prescription or refill of a medication. In the case of antidepressants, it will advise patients and their families about the risk of suicidality and about precautions that can be taken. FDA is working with manufacturers of antidepressant drugs to make the med guides available as soon as possible. Novartis has notified healthcare professionals about new precautions for the company's two bisphosphonate drugs, so meta or zoologonic acid and eredia or pyimidrinate disodium. These drugs are used to treat hypercalcemia of malignancy and other disease states. The labeling now cautions about reports of osteonecrosis of the jaw occurring in cancer patients who received bisphosphonates as a component of their therapy. Many of these patients were also receiving chemotherapy, some with corticosteroids and these are also risk factors for osteonecrosis. The majority of the osteonecrosis cases were associated with dental procedures such as tooth extractions and many of these patients had signs of local infection including osteomyelitis. So the labeling now advises prescribers to consider having patients with these and other risk factors undergo dental evaluation and necessary preventive dental care before they start on zometta or eredia treatment. While they're on these drugs, high risk patients should avoid invasive dental procedures if possible and if patients do develop osteonecrosis of the jaw while on bisphosphonate therapy they should avoid dental surgery. And finally, if patients on bisphosphonates do require dental procedures, there are no data available on whether stopping the drugs reduces the risk of osteonecrosis of the jaw. The clinical judgment of the physician should guide each patient's management based on an assessment of benefits and risks. Pulmonetic Systems Incorporated has recalled its LTV series ventilators. The model number for the recalled ventilators are 1,950, 900 and 800. The 10,000 of these devices are in use throughout the world both in hospitals and also in home care settings. Why did they recall these ventilators? Because the ventilator may fail to operate when it switches from an external power source to the battery that's built into the device. And when is that kind of switch supposed to happen? Well it's supposed to happen automatically under certain circumstances. It happens when the external power source is removed or it fails or it's unstable or it's not adequate to operate the ventilator. If the switch to the battery operation doesn't occur as it should then the ventilator can fail to breathe for the patient. What does this recall consist of? Right now the company is working on a permanent fix that should take care of all of the ventilators. In the meantime, the company sent a safety alert and an information sheet to customers and users and that explains the problem and it provides instructions on how to correct the malfunction if it occurs and continue ventilation. And that will do the trick? Well the company says that if you follow those instructions the ventilator will usually continue to function but they do caution that caregivers should have an alternative source of ventilation on hand if it becomes necessary. If you have one of these pulmonetics LTV series ventilators and the company hasn't yet provided the permanent fix for your unit, you should follow the operating instructions in the safety alert and the caregiver information sheet that the company sent. If you don't have these documents you can get them on our website or you can call pulmonetics directly. FDA has received over 90 reports of fires involving electrically operated hospital beds since 1993. Most of these fires were associated with factors such as overheated bed motors, arcing from ill-thinning plugs, damaged plugs, missing ground pins, fluid leaks that damage circuit boards, missing components in the wiring, poor maintenance or failure to follow manufacturer's warnings. Fortunately such fires are rare and a recent FDA article in Nursing 2004 talks about ways to help keep them rare. Now most of these tips might sound like common sense but they're especially important for older beds. So here are just a few of them. Periodically inspect the bed's power cord for damage. Don't use an extension cord or a multiple outlet strip. Instead connect the bed's power cord directly into a wall-mounted outlet that's in good working order. Inspect the floor under the bed for a buildup of dust and lint which could clog the motor. Inspect the covering of the patient's bed control panel and look for signs of damage where liquids could leak in. Test the bed and its controls including patient lockout features to be sure that the bed can move freely in both directions without pulling or rubbing on cords. And finally tell staff about any unusual sounds or burning odors or an unusual movement of the bed. Biogen IDEC and Genentech have notified health professionals about new warning information in the labeling for the drug Rituxin or Rituximab which is used to treat certain patients with non-Hodgkin's lymphoma. The new labeling warns of hepatitis B reactivation in some patients which has led to fominate hepatitis, hepatic failure and death. The warning says that patients at high risk of HBV infection should be screened for the presence of HBV before initiating treatment with Rituximab. Those found to be carriers of HBV should be closely monitored for signs of active HBV infection or hepatitis both during the treatment and for several months afterwards. If a patient develops viral hepatitis while being treated with Rituximab, the drug should be discontinued along with any concomitant chemotherapy and treatment should be started including antiviral therapy. There's currently insufficient information about whether it's safe to resume Rituximab therapy in patients who developed hepatitis due to HBV reactivation while they were being treated with the drug. When you're using steam sterilizers for medical instruments, physical, chemical and biological monitors help assure that sterilization has taken place. In a recent article, FDA cites several reports of problems with these monitors. In one case, the liquid growth media in a self-contained biological monitor had dried out. In another case, one chemical indicator had failed to change color even though another one in the same sterilizer cycle did change. And in a third case, a physical monitor showed that the required temperature wasn't reached and yet the sterilizer didn't warn that this had happened. The article suggests several ways to address these kinds of events. For example, for self-contained biological indicators, always check the level of the growth media before and after sterilization. And don't use indicators with low levels of media. If a biological or chemical indicator gives unexpected results, this could be because the sterilizer was overloaded or improperly loaded so that steam couldn't penetrate or circulate to reach the indicator. Or it could be that the sterilizer isn't delivering good quality steam. The article also cautioned that if you program your sterilizer to operate at other than the manufacturer's settings for time and temperature, you should develop a system to be sure that these are set properly by the staff. For example, you might require that a second person verify the settings before the sterilizer is returned to service. Here's a caution for patients who are prescribed low-trizone lotion, a combination of beta-methazone and clotrimazole that's used to treat fungal infections of the skin such as athlete's foot, jock itch, and ringworm. We've had several reports of patients who've used this product in their eyes or ears rather than on their skin. Fortunately, none of these patients had permanent injuries, but all required medical attention. But most products that are intended for topical use are not mistakenly used, for example, in the ears. Why this product? Well, one factor might be how the product is packaged. Low-trizone lotion comes in containers that look like ophthalmic, odic, and nasal drug products. Plus, the plastic tip looks like a dropper. That may contribute to the confusion, and it also makes it easier to put the lotion in the eyes or ears as compared to a tip that's blunted or flat. But doesn't the label make it clear that this is for a topical use only? The label does say for topical use only, but that might be difficult to spot because of the size of the lettering or the way that the warning is embedded with other words on the label. FDA is working with the manufacturer to change the labeling and packaging. In the meantime, here are some suggestions to help reduce the chance of these mixups. First, counsel patients on proper use of the product and tell them about the potential for confusion. Advise patients who also use odic or ophthalmic preparations to store low-trizone lotion where it's unlikely to be confused with those other products. And if possible, circle or highlight the for topical use only statement on the product package and container. FDA recently cleared for marketing an automatic external defibrillator that can be sold over the counter to the general public. It's called the Heart Start Home Defibrillator, and it's made by Phillips Medical Systems. This product was already available for use at home with a doctor's prescription, but now it can be purchased without a prescription. Like other defibrillators, the device administers an external electric shock through the chest wall to the heart to help restore normal heart rhythm to patients in ventricular fibrillation. The device analyzes and interprets the patient's heart rhythm and advises the user on whether to deliver a shock. Consumers should know that the Heart Start device is supposed to be used only on people believed to be in sudden cardiac arrest who don't respond when they're shaken and are not breathing normally. It should only be used on adults or on children who are at least 8 years old or who weigh at least 55 pounds. Special small pads for younger children and infants are available by prescription. In the training video that comes with the device, users dealing with a person in cardiac arrest are advised to first call 911. Then they should get the defibrillator. Pulling the device's cartridge handle starts voice instructions to guide the user through each step. The user is instructed to remove all clothing from the patient's chest. When the patient's chest is bare, the user removes the protective cover, takes out the white adhesive pads, and attaches them to the victim's chest exactly as shown in the pictures on the pads. Once the pads are in place, the defibrillator analyzes the victim's heart rhythm and decides if a shock is needed. If a shock is needed, the defibrillator says to push the flashing orange button. If a shock isn't needed, the device says so and instructs the user to begin CPR if necessary. The flashing blue I button lets the user know that more information is available. Pushing that button gives step-by-step coaching on performing CPR. One last note, although the Heart Start Home defibrillator is designed for use by virtually anyone, people who may be using this device are also advised to take CPR training in case that's needed instead of a shock. 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.