 This is FDA Patient Safety News. In this edition, a possible link between antidepressants and children and suicidality, the counterfeiting of proline surgical mesh, a caution on possible fires when using sevel fluorine and anesthesia machines, and mix-ups between the drugs Keppra and Keletra. 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 Reiner. Let's start with some medical products FDA recently approved. FDA recently approved Prussian Blue to treat people who have been internally contaminated by ingesting or inhaling particles of radioactive cesium-137 or thallium. The product is called radiogardase, and it's made by the German firm Heil. Prussian Blue is the first available therapy to help reduce the body's burden of these elements. It works by trapping cesium-137 and thallium in the intestine so that they can be eliminated in the stool rather than reabsorbed. Prussian Blue has been used for this purpose over the last several decades. But if it's been used for so long, why the approval now? Well, FDA encouraged manufacturers to submit marketing applications for Prussian Blue to help make drugs to treat radiation contamination more widely available in the event of a terrorist attack. Having the approval will help assure that the product meets high standards of quality and that proper instructions for its use are available. What's the message for clinicians about all this? Well, we want clinicians to know that Prussian Blue can be used to treat internal radiation contamination in the case of a terrorist event such as a dirty bomb attack. It's also effective in treating thallium poisoning. Right now I'm assuming that the Prussian Blue has to be given right away after the person inhales or ingests the material, is that right? Yes, it should be taken as soon as possible after exposure. However, even when treatment cannot be started right away, patients should be given Prussian Blue as soon as it becomes available because it's still effective even after some time has elapsed. What about side effects? Well, the most commonly reported side effects are constipation and stomach upset. Now, a dirty bomb can contain radioactive material other than season 137. Is Prussian Blue going to be effective in dealing with those as well? Well, we're not aware of any clinical data that shows that Prussian Blue is effective in those cases. When the kind of radiation contamination isn't known, Prussian Blue should be given together with other drugs such as potassium iodide, calcium or zinc, DTPA or sodium alginate that are known to be effective in treating contamination from other radioactive substances. Ethicon Incorporated recently issued an alert about a counterfeit mesh product labeled as proline. Proline is a non-absorbable polypropylene mesh that's used in the repair of hernias and other fascial deficiencies. Ethicon says that the counterfeit product is a flat mesh measuring 3 by 6 inches with a product code of PMII. So far, the affected lot numbers are RBE609 and RJJ130. The company says that there are some differences that may distinguish the counterfeit product from authentic proline. For example, the counterfeit mesh may have a tighter asymmetrical weave compared to the open linear weave of authentic proline mesh. The counterfeit product may have a jagged end along the 3-inch side where authentic proline mesh is smooth. And the Ethicon logo on the counterfeit box appears in a thicker typeface than authentic proline. Ethicon is advising physicians, nurses and other health care professionals to carefully examine all 3 by 6 inch flat mesh proline before using it. If you receive any of this product that you suspect is counterfeit, quarantine it so it won't be used and contact your distributor for instructions about return. FDA is testing samples of suspected counterfeit material for composition and sterility and will make the results available on our website. In the meantime, you should continue to monitor patients implanted with suspected counterfeit mesh for infection or any other adverse outcome just as you would a patient with any mesh implant. If you have medical questions regarding suspected counterfeit product, you can contact the Ethicon Customer Service Center at 1-877-Ethicon. In a previous edition of FDA Patient Safety News, we told you about a possible increased risk of suicidal thinking and suicide attempts in children and adolescents being treated with Paxil for major depressive disorder or MDD. Now, in a new advisory, FDA is alerting healthcare professionals about reports of suicidal ideas and attempts in pediatric MDD patients who are being treated with a variety of antidepressant drugs and clinical trials. But Mark, aren't suicidal thinking and suicide attempts associated with major depressive disorder anyway? Of course they are, but it's possible that some of these drugs could increase the risk. FDA's preliminary review of eight antidepressant drugs and clinical studies suggests that there may be an excess of suicidality reports related to several of these drugs compared to a placebo. The FDA advisory knows that there have been stories in the news media and in professional journals reporting on suicide-related events when antidepressants are used in children. But the advisory points out that these events are very difficult to interpret without a control group since they also occur in untreated patients with depression. Well, how sure are we that the use of these drugs in children raises the risk of suicidality? At this point, it's too early to tell, in fact, whether there's a direct causal link between using these drugs and an increased risk. The eight drugs have been used on more than 4,100 pediatric patients in clinical trials, and there have been no reports of completed suicides to date. But an increased risk of suicidality can't be ruled out for any of these antidepressant drugs. FDA's advisory says that additional data and analysis are needed, and, in fact, the FDA has scheduled a meeting to promote a public discussion of the available data. So, in the meantime, what's FDA advising clinicians? Well, one thing the advisory does is to remind clinicians that the only drug shown in clinical trials so far to be effective in treating this condition in children is Prozac. But it also notes that the failure of any single study to show effectiveness doesn't necessarily mean that the drug isn't effective. The advisory recognizes that there aren't many established treatment options for children with MDD, and so clinicians treating them often must choose among treatments that are available for adults with MDD. The advisory also stresses that these antidepressant drugs should be used with caution, whether you're treating children or adults. It points out that the drug labeling already says that suicide attempts are an inherent possibility in MDD, and they may persist until significant remission occurs. So, high-risk patients should be closely supervised during initial drug therapy, and also in order to reduce the risk of an overdose, prescriptions should be written for the smallest number of tablets consistent with good patient management. There was a message to be passed on to patients in the advisory, too. The advisory says that patients should not discontinue these drugs without first consulting with their physicians. For some of these drugs, it's important that they're not abruptly discontinued. The advisory tells parents and other caretakers of children who are on antidepressants to talk to their doctors about these drugs. You know, you can find a copy of the FDA advisory on our website, and as more information becomes available, we'll update you on future editions of FDA Patient Safety News. Abbott Laboratories has sent a letter to healthcare professionals about its product, ultane, or sevofluorine, a general anesthetic. The letter warns about rare reports of fires or extreme heat in the respiratory circuit of anesthesia machines when this product is used. Although the exact cause of the fires hasn't yet been determined, in most cases, the CO2-absorbent material used with the ultane had become desiccated. This may have led to an increased exothermic reaction between the sevofluorine and the absorbent material. The letter from Abbott provides a number of recommendations to reduce the risk of fires or excessive heat. Let's summarize them. First, replace the CO2-absorbent if you suspect it's become desiccated because it hasn't been used for a long time. Turn off the anesthesia machine completely at the end of each clinical use. If the machine is left on, fresh gas continues to flow through it at a low rate, and this may accelerate the drying of the absorbent. Turn off all vaporizers when they're not in use. Before you use a new CO2-absorbent, check the integrity of the packaging. Periodically monitor the temperature of the CO2-absorbent canisters. Monitor the correlation between the sevofluorine vaporizer setting and the concentration of the inspired sevofluorine. If you notice an unusually delayed rise or an unexpected decline in the inspired sevofluorine concentration when you compare it to the vaporizer setting, this could indicate that there's excessive heating in the absorbent canister. And finally, replace CO2-absorbents routinely regardless of what the color indicator shows. The color indicator doesn't necessarily change as a result of desiccation. There's additional important information in Abbott's letter if you use Ultane, be sure you have a copy. You can get one on our website or from Abbott's Medical Information Department at 1-800-633-9110. The drug company UCB Pharma has sent a letter to health care professionals warning of potential mix-ups between their drug, Keppra, and another drug, Keletra, which is a product of Abbott Laboratories. Keppra or Leviteracetam is an anti-epileptic. Keletra, a combination of lopinivir and ratonivir, is an antiretroviral. Of course, mix-ups between any drugs can expose patients to adverse events from a medication they didn't need. But in this case, a mix-up could also result in an epileptic patient missing medication and possibly experiencing status epilepticus or an HIV-positive patient not receiving critical therapy. The two products don't look alike. What can look alike and also sound alike are their names, and that's the source of the problem. Here's what UCB Pharma recommends to prevent mix-ups. First of all, write or speak the drug name clearly when prescribing these medications. Second, when it's appropriate, include the intended use of the drug on prescriptions. And third, counsel patients to check the medications they receive and bring any questions to the pharmacist's attention. In other words, encourage patients to examine the medication as soon as they receive it and immediately let the pharmacist or physician know if it looks different from previous prescriptions of the same drug. Every year, tens of millions of vaccinations are given to children and adults in this country to prevent serious infectious diseases. FDA and CDC work together to monitor the safety of these vaccines using a registry known as the Vaccine Adverse Event Reporting System, or VAERS. The VAERS registry contains reports of adverse events from patients, parents, and healthcare providers, and it can help to identify important new vaccine safety concerns. Take the example of the rotavirus vaccine. During the first months after this vaccine was approved, epidemiologists at FDA and CDC published 15 VAERS reports of infants who had developed a particular type of intestinal obstruction after receiving the vaccine. The report signaled a potential problem which led to further investigations, and as a result, the vaccine program was suspended, and then later, as investigations verified the serious risk, the manufacturer voluntarily removed the vaccine from the market. Of course, it takes multiple reports and thorough investigation to confirm a causal relationship between an adverse event and a vaccine. Still, VAERS reports are on the front line in making sure that vaccines are safe by providing a rapid signal that problems may be occurring. Sometimes, VAERS reports highlight errors in prescribing or administering vaccines. For example, the VAERS registry was found to contain reports of 22 pregnant women who had received live virus varicella vaccine by mistake after being exposed to chickenpox. These women should have received a different product, varicella zoster immune globulin, or VZIG. In this case, FDA and CDC worked with the varicella vaccine manufacturer to publish details about the 22 cases. By publishing this information, we were able to alert healthcare professionals of this potential mix-up and thus help prevent future cases. It's important to keep the VAERS system working, and we can't do that without your help. We're asking that you report any significant adverse event that occurs after a vaccination, even if you're not sure that the vaccine caused it. It's easy to report by internet, phone, fax, or mail. You can find out how to do that 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 Anita Reiner. And I'm Mark Barnett. See you next time.