 This is FDA Patient Safety News. In this edition, a possible link between certain erectile dysfunction drugs and optic neuropathy, a recall of Baxter colleague infusion pumps, the importance of maintaining anti-platelet therapy with drug-alluding stents, and revised warnings on the anti-epileptic drug trileptol. 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. Our first story is about a possible link between vision problems and certain drugs used to treat erectile dysfunction. FDA is alerting healthcare practitioners about a possible association between PDE5 inhibitors that are used to treat erectile dysfunction, such as Viagra, Levitra, and Cialis, and a serious vision disorder. This condition, known as NION, or non-arturidic ischemic optic neuropathy, can cause a sudden loss of eyesight by blocking blood flow to the optic nerve. This possible association is reflected in newly approved labeling for these drugs. Thus far, over 40 cases of NION have been reported in patients using the drugs, and 26 of these patients experience continuing or permanent vision loss. While considering the very large number of people that are taking these drugs, 40 or 50 cases seems rather low. Well, that's right. The proportion of patients taking the drugs who are experiencing this is probably very small. Nevertheless, since NION can produce permanent vision loss, it is important for physicians and patients to be aware of the possible risk. Now, you just said possible risk. How certain are we that the drugs are responsible for these vision problems? Well, we're not certain. It could be the drugs, or it could be certain other known risk factors like diabetes, smoking, hyperlipidemia, hypertension, but in about half of the reported cases, there was a temporal relationship between taking the drug and the onset of visual symptoms, and that does raise some concern about the role of the drugs. So what's the message for the practitioner? First of all, to caution patients who are taking these drugs that if they experience a sudden loss of vision, either in one eye or in both eyes, to immediately stop the medication and seek medical attention. And secondly, practitioners should ask patients whether they've ever experienced severe loss of vision, which might indicate that they've had a prior episode of NION. These patients are at increased risk of developing the condition again. Baxter Health Care Corporation is recalling all models of its colleague volumetric infusion pumps because a design problem can cause these devices to shut down while a patient is receiving infusion therapy. Over 200,000 of these devices have been distributed to physicians, hospitals, pharmacies, and other medical facilities in the U.S. At least three patients have died and six have been seriously injured when their infusion pump unexpectedly shut down. These devices may also have two other problems. First of all, because of the way the pump is designed, it's possible to inadvertently press the on-off key instead of the start key when you're trying to start an infusion. Also, if the pump is left on while it's being connected or disconnected from a hospital's monitoring system, the device can fail so the infusion has to be restarted. Baxter is working on a permanent solution to these problems. In the meantime, here are the company's recommendations. First, if a colleague pump displays certain failure codes, remove the pump from service. These failure codes are displayed when the pump detects an anomalous situation. You can find the list of affected codes on our website. Review the event history of every colleague pump still being used. Any pumps that have exhibited one of the affected failure codes in the past should also be taken out of service. Once these failures may occur during an infusion, have a contingency plan to minimize disruptions of infusion therapy. For example, have a backup pump available. And finally, the company says that you should consider not using these pumps in situations where a malfunction could have life-threatening results or where a replacement pump is not available. FDA has received a number of reports of adverse events that occurred in patients who received drug-alluding coronary stents and then stopped taking their anti-platelet medication prematurely. These events included stent thrombosis, MI, and death. And they occurred in patients who received both of the currently marketed drug-alluding stents, the Cypher stent system made by Cortis Corporation and the Taxis stent system made by Boston Scientific Corporation. Sometimes these events occurred when patients stopped and I played with therapy early because of non-compliance. In other cases, practitioners asked the patient to stop the medication because they were going to have elective surgical or dental procedures or because the patient experienced minor bleeding. As a result, both Cortis and Boston Scientific have now changed the labeling for their drug-alluding stents to emphasize the importance of patient compliance with the anti-platelet recommendations and the risks of prematurely discontinuing anti-platelet therapy. The labeling also points out that physicians should carefully consider whether a drug-alluding stent is a treatment of choice if the patient is anticipating a surgical or dental procedure that might require stopping anti-platelet therapy. Now if a surgical or dental procedure is recommended after the stent is implanted, then the risks and benefits of the procedure should be weighed against the possible risk associated with prematurely discontinuing anti-platelet therapy. And finally, patients who must stop anti-platelet therapy early should be carefully monitored for cardiac events. At the discretion of the treating physician, anti-platelet medication should be restarted as soon as possible. In several previous programs, we've reported on the increased risk of suicidal thoughts and behavior in pediatric patients being treated with antidepressant drugs. FDA recently issued a public health advisory on the possible suicidal risk in adults taking these drugs. The advisory notes that several recent scientific publications suggest that adults being treated with antidepressants may have an increased risk of suicidal behavior. Even before these reports were published, FDA had begun to review all the available data to determine whether there is an increased risk in adults. As part of this effort, FDA has asked antidepressant manufacturers to provide information on all placebo-controlled clinical trials conducted in adults. This is the approach that was used earlier to evaluate suicidality in children taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete. In the meantime, certain warnings are being re-emphasized. First, adults being treated with antidepressant medicines, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close monitoring may be especially important during the first few months of drug therapy or when the dose is either increased or decreased. Adults whose symptoms worsen while being treated with antidepressants, including those who experience an increase in suicidal thinking or behavior, should be evaluated. Public corporation has notified physicians about problems with certain of the company's implantable pacemakers that could lead to premature battery depletion without warning or periods of inappropriate pacing or other malfunctions. A seal within the devices can leak, allowing moisture to affect the electronic circuits. Although infrequent, these device failures have led to syncope in some cases and possibly to heart failure resulting from too rapid a pacing rate. The affected pacemakers are the Pulsar-Max, Pulsar, Discovery, Meridian, Pulsar-Max II, Discovery II, Virtus Plus II, Intellis II, and Contact TR. All of these models were manufactured between 1997 and 2000 and none of them are still being made. About 18,000 U.S. patients still have these pacemakers implanted. Patients with these pacemakers should be advised to seek medical attention immediately if they notice a prolonged rapid heart rate, experience syncope, or have new or increased symptoms of heart failure. And Gaiden advises physicians to consider increasing the frequency of follow-ups both in the office and trans-telephonically. FDA is not making a recommendation as to whether these devices should be replaced in patients who have them. Removing and replacing the device may pose some risk and so it's important that patients and physicians carefully discuss this matter before making a decision. This is particularly important for patients who may be pacemaker dependent. You can get more detailed information on our website and we'll also update the website as we receive more information. Serono Incorporated has notified healthcare professionals about additional safety information for the drug Novantrone, mitazantrone, which is used to treat some patients with MS. Novantrone's label now has updated warnings on the risks of cardiotoxicity and also of secondary leukemia. The boxed warning was recently updated to recommend more frequent monitoring of left ventricular rejection fraction, or LVEF. In addition to an LVEF measurement at baseline, it's now recommended that LVEF should be reevaluated in MS patients before every dose of Novantrone. The labeling continues to recommend that patients with a baseline LVEF of less than 50% should not be treated with this drug. It also shouldn't be given to patients who've had a drop in LVEF to below 50% or to those who've had a clinically significant reduction in LVEF during Novantrone therapy. The information in the labeling regarding secondary acute myelogenous leukemia or AML was also recently updated to provide risk estimates for MS patients treated with Novantrone. Back in 1998, FDA cautioned practitioners about the possible hazard of administering albumin to critically ill patients. The FDA notifications cited a meta-analysis which found that critically ill patients who received albumin had an increased risk of dying compared with those who received normal saline. FDA has now updated that information based on a large randomized controlled trial. The new study found that for ICU patients who require fluid resuscitation, those who receive albumin do not experience a higher mortality rate than those who receive saline. So in view of these results, FDA's Blood Products Advisory Committee decided that the new study has largely resolved the earlier safety concerns about giving albumin to critically ill patients. But several questions remain unanswered. For example, the relative safety of albumin in burned patients is still unknown since these patients were excluded from the study. And the study indicated that patients with traumatic brain injury who receive albumin may experience an increased mortality rate. Novartis Pharmaceuticals has alerted healthcare professionals about new safety information for the anti-epileptic drug trileptol or oxcarbazepine. The labeling has new warnings about serious and sometimes life-threatening dermatological reactions that have occurred in both children and adults being treated with trileptol. They've included Stevens-Johnson syndrome and toxic epidermal necrolysis. These skin reactions have been reported at a three to tenfold higher rate than the estimated background incidents for these reactions. They've also recurred after re-challenge with trileptol. Therefore, Novartis says that if a patient develops a skin reaction while taking the drug, you should consider stopping trileptol and prescribing another anti-epileptic medication. The labeling also questions that multi-organ hypersensitivity reactions have occurred in both adults and children shortly after starting trileptol therapy. The signs and symptoms were diverse, but they often included fever and rash associated with other organ system involvement. If you suspect a multi-organ hypersensitivity reaction, trileptol should be discontinued and an alternative treatment should be started. FDA has alerted healthcare professionals about patients who have swallowed capsules intended for use with inhalers. We've received over 30 reports where capsules for the foradil arylizer were taken orally, as well as four similar reports for the sporeva handyhaler. The problem stems from the fact that these capsules resemble those taken by mouth and that their labels don't prominently warn against oral ingestion. FDA is working with the manufacturers on labeling and packaging changes that are going to minimize the likelihood of errors. In the meantime, FDA's alert recommends several precautions. Here are a few of them. First, try to avoid dispensing the capsules separately from the inhalation device. If it's necessary to dispense the capsules separately, affix a cautionary label that reads, for inhalation use with special inhaler only. And advise patients to store the inhaler capsules with the inhaler away from any area where oral capsules are kept. 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.