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U.S. Department of Health and Human Services

Show #43, September 2005

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Show #43, September 2005

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 Recalls and Safety Alerts

September2005FDA Patient Safety News Homepage
Possible Link between Erectile Dysfunction Drugs & Optic Neuropathy (Video, print, and e-mail functions)
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FDA is alerting healthcare practitioners about a possible association between PDE-5 inhibitors used to treat erectile dysfunction, such as Viagra, Levitra and Cialis, and a serious vision disorder. This condition, known as NAION, or non-arteritic 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 NAION have been reported in patients using the drugs, and 26 of these patients experienced continuing or permanent vision loss.

Though the proportion of patients affected is probably very small, since NAION can produce permanent vision loss, it's important for physicians and patients to be aware of the possible risk. Moreover, we do not know for sure that these drugs were responsible for the vision problems. 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.

Practitioners should caution patients who are taking these drugs that if they experience a sudden loss of vision in one or both eyes, to immediately stop the medication and seek medical attention. Practitioners should also ask patients whether they've ever experienced severe loss of vision, which might indicate that they've had a prior episode of NAION. These patients are at increased risk of developing the condition again.

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September2005FDA Patient Safety News Homepage
Baxter Recalls Colleague Infusion Pumps (Video, print, and e-mail functions)
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Baxter Healthcare 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, because of the way the pump is designed, it's possible to inadvertently press the on/off key instead of the start key when 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:

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 web site.

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.

Since these failures may occur during an infusion, have a contingency plan to minimize disruptions of infusion therapy. For example, have a back-up 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.

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September2005FDA Patient Safety News Homepage
Importance of Antiplatelet Therapy with Drug-Eluting Stents (Video, print, and e-mail functions)
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FDA has received a number of reports of adverse events that occurred in patients who received drug-eluting coronary stents and then stopped taking their antiplatelet medication prematurely. These events included stent thrombosis, MI and death, and they occurred in patients who received both of the currently marketed drug-eluting stents: the Cypher stent system made by Cordis Corp., and the Taxus stent system, made by Boston Scientific Corp.

Sometimes these events occurred when patients stopped antiplatelet 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 Cordis and Boston Scientific have now changed the labeling for their drug-eluting stents to emphasize the importance of patient compliance with the antiplatelet recommendations and the risks of prematurely discontinuing antiplatelet therapy.

The labeling also points out that physicians should carefully consider whether a drug eluting stent is the treatment of choice if the patient is anticipating a surgical or dental procedure that might require stopping antiplatelet therapy.

If a surgical or dental procedure is recommended after the stent is implanted, the risks and benefits of the procedure should be weighed against the possible risk associated with prematurely discontinuing antiplatelet therapy. And finally, patients who must stop antiplatelet therapy early should be carefully monitored for cardiac events. At the discretion of the treating physician, antiplatelet medication should be restarted as soon as possible.

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September2005FDA Patient Safety News Homepage
FDA Reviews Antidepressant Use in Adults (Video, print, and e-mail functions)
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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 suicidality 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 reemphasized:
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.

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September2005FDA Patient Safety News Homepage
Problems with Certain Guidant Pacemakers (Video, print, and e-mail functions)
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In a July 18th letter, Guidant Corporation 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, INTELIS II, and CONTAK TR. All of these models were manufactured between 1997 and 2000, and none 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 Guidant advises physicians to consider increasing the frequency of follow-ups, both in the office and transtelephonically.

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, 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 web site. We'll also update the web site as we receive more information.

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September2005FDA Patient Safety News Homepage
Updated Warnings for Novantrone (Video, print, and e-mail functions)
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Serono, Inc. has notified healthcare professionals about additional safety information for the drug Novantrone (mitoxantrone) which is used to treat some patients with multiple sclerosis (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 ejection fraction (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 percent 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 percent, or those who've had a clinically significant reduction in LVEF during Novantrone therapy.

The information in the labeling regarding secondary acute myelogenous leukemia (AML) was also recently updated to provide risk estimates for MS patients treated with Novantrone.

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September2005FDA Patient Safety News Homepage
New Information on the Safety of Albumin for Critically Ill Patients (Video, print, and e-mail functions)
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Back in 1998, FDA cautioned practitioners about the possible hazard of administering albumin to critically ill patients. The FDA notification 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. This 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. 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 burn 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.

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September2005FDA Patient Safety News Homepage
Warnings Revised for Trileptal Tablets & Oral Solution (Video, print, and e-mail functions)
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Novartis Pharmaceuticals has alerted healthcare professionals about new safety information for the antiepileptic drug, Trileptal (oxcarbazepine). The labeling has new warnings about serious, sometimes life-threatening dermatological reactions that have occurred in both children and adults being treated with Trileptal. They've included Stevens-Johnson syndrome and toxic epidermal necrolysis.

These skin reactions have been reported at a 3 to 10-fold higher rate than the estimated background incidence for these reactions. They've also recurred after rechallenge with Trileptal. Therefore, Novartis says that if a patient develops a skin reaction while taking the drug, you should consider stopping Trileptal and prescribing another anti-epileptic medication.

The labeling also cautions that multiorgan hypersensitivity reactions have occurred in both adults and children shortly after starting Trileptal therapy. The signs and symptoms were diverse, but often included fever and rash associated with other organ system involvement. If you suspect a multiorgan hypersensitivity reaction, Trileptal should be discontinued and an alternative treatment should be started.

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 Preventing Medical Errors

September2005FDA Patient Safety News Homepage
Accidental Oral Administration of Capsules for Inhalation Devices (Video, print, and e-mail functions)
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The FDA has alerted health care professionals about patients who have swallowed capsules intended for use with inhalers. We've received over 30 reports where capsules for the Foradil Aerolizer were taken orally, as well as four similar reports for the Spiriva HandiHaler.

The problem stems from the fact that these capsules resemble those taken by mouth, and their labels don't prominently warn against oral ingestion. FDA is working with the manufacturers on labeling and packaging changes that will 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.

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