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U.S. Department of Health and Human Services

Show #71, January 2008

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Show #71, January 2008

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 Recalls and Safety Alerts

January2008FDA Patient Safety News Homepage
Serious Skin and Hypersensitivity Reactions with Provigil (Video, print, and e-mail functions)
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Cephalon has notified healthcare professionals about new safety information for Provigil (modafinil). Provigil is used to reduce excessive sleepiness in adult patients with narcolepsy and other sleep disorders. Provigil is not approved for any indication in children.

The revised labeling warns that Provigil can cause life-threatening skin reactions, including Stevens-Johnson Syndrome (SJS). Although benign rashes can also occur with this drug, the company says that it is not possible to reliably predict which rashes will be serious. Because of this, Provigil should ordinarily be stopped at the first sign of a rash, unless the rash clearly is not related to the drug.

The labeling also warns that Provigil can cause other serious hypersensitivity reactions. If a multi-organ hypersensitivity reaction is suspected, the drug should be discontinued. Patients should be told to stop taking the drug if they develop signs or symptoms suggesting angioedema or anaphylaxis.

Provigil can also cause psychiatric symptoms, including anxiety, mania, hallucinations and suicidal ideation. The company advises caution when the drug is given to patients with a history of psychosis, depression or mania. If psychiatric symptoms develop, consider discontinuing the drug.

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January2008FDA Patient Safety News Homepage
Sudden Hearing Loss from Erectile Dysfunction Drugs (Video, print, and e-mail functions)
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FDA has received about 30 reports of sudden hearing loss in patients taking a class of erectile dysfunction drugs called PDE5 inhibitors. This class of drugs includes Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil). The problem was sometimes accompanied by tinnitus, vertigo, or dizziness. In most cases the hearing loss involved one ear, and about a third of the time it was temporary.

Medical follow-up information was often limited for the reported cases, which makes it difficult to determine whether these reports are directly related to the use of one of these drugs, an underlying medical condition, or other risk factors for hearing loss, a combination of these factors, or other factors.

FDA has asked the manufacturers of these erectile dysfunction drugs to display the risk of hearing loss more prominently in the labeling, and to guide patients on what to do if they experience hearing problems while they are on the drugs. The revised label will advise clinicians to let patients know that sudden hearing loss may be due to the drug, and to stop taking the drug and seek medical attention if they experience any sudden decrease or loss of hearing.

Another PDE5 inhibitor, Revatio, also contains sildenafil, the same active ingredient as in Viagra. However, Revatio is used to treat pulmonary arterial hypertension rather than erectile dysfunction. FDA is working with the manufacturer of this drug to revise its labeling, too. Because pulmonary hypertension is a life-threatening condition, patients taking Revatio should not stop taking their medication, but should be instructed to contact their physician promptly if they experience sudden hearing loss.

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January2008FDA Patient Safety News Homepage
Certain Welch Allyn Defibrillators Recalled (Video, print, and e-mail functions)
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The device company, Welch Allyn, is recalling some of its AED 10 automatic external defibrillators. A defective capacitor in some of these devices may cause them to malfunction, and in some cases this may prevent the defibrillator from analyzing a patient's ECG properly. If that happens, the device may fail to deliver a shock.

The affected AED 10 devices were manufactured between March 29, 2007 and August 9, 2007 and have part numbers 970302E, 970308E, 970309E, 970310E, and 970311E. The company plans to replace all affected units and has set up a call center for customers. To arrange for a replacement for a recalled device, contact Welch Allyn at 1-800-462-0777 (option 4).

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January2008FDA Patient Safety News Homepage
Marketing of Trasylol Suspended (Video, print, and e-mail functions)
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UPDATE 5/14/08: Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.

Bayer Pharmaceuticals has suspended the marketing of Trasylol (aprotinin) which is used to reduce perioperative blood loss during cardiac surgery with cardiopulmonary bypass. Preliminary results of a Canadian study indicate that while patients given Trasylol experience fewer serious bleeding events, they may also have a greater risk of death than patients taking either of two other antifibrinolytic drugs.

Sales of Trasylol will be suspended until FDA can conduct a thorough analysis of the study and gain a better understanding of the risks and benefits of the drug. Because there are few treatment options for patients at risk for excessive bleeding during cardiac surgery, FDA is working with Bayer to gradually phase Trasylol out of the marketplace so that it doesn't cause shortages of other drugs used for this purpose.

FDA is also exploring ways that physicians may continue to have access to Trasylol in specific cases where the benefits of the drug outweigh the risks.

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January2008FDA Patient Safety News Homepage
Warning on Fentora Buccal Tablets (Video, print, and e-mail functions)
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FDA is warning healthcare professionals about deaths and patient injuries from Fentora (fentanyl buccal tablets) a drug used to treat breakthrough cancer pain.

Some of these events occurred because the drug was prescribed for patients who should not have received it. Fentora should only be used for breakthrough pain in opioid-tolerant cancer patients who are already taking around-the-clock opioids. Life-threatening respiratory depression can occur if the drug is used in patients who are not opioid-tolerant, and so it should not be prescribed for acute or postoperative pain, migraines, headaches, or pain due to injuries.

Other adverse events occurred because the dosing instructions in the product labeling were not followed. The labeling states that if the breakthrough pain episode is not relieved within 30 minutes of the first dose, patients may take only one additional tablet of the same strength for that episode. If the breakthrough pain continues even after the second dose, no more Fentora may be used for that episode. In other words, patients should never take more than two doses of Fentora to treat an episode of breakthrough pain. And they must wait a minimum of four hours after the second dose before treating another episode of breakthrough pain.

Adverse events also occurred when prescribers or pharmacists substituted Fentora for Actiq without adjusting the dose. Actiq is an oral transmucosal product containing fentanyl, but its bioavailability is lower than Fentora. So Fentora cannot be substituted for Actiq on a mcg-for-mcg basis. In making the switch from Actiq to Fentora, the dose must be adjusted downward by following the table in the product label.

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January2008FDA Patient Safety News Homepage
Recall of Thoratec Implantable Ventricular Assist Devices (Video, print, and e-mail functions)
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The Thoratec Corporation is recalling some of its implantable ventricular assist devices (IVADs) because air leaks could develop in the driveline when the device is used outside the patient's body. Five injuries and one death have been reported as a result of this problem.

These IVADs were designed to be implanted in the body. However, they have sometimes been used externally when certain patient characteristics prevent implantation. In the external position, damage can occur to the pneumatic driveline if it is bent at a sharp angle where the driveline meets the pump housing. One patient died when the driveline severed at its connection to the pump.

The recalled devices, which were distributed to 87 hospitals in the U.S. and abroad, have serial numbers 488 or higher. The serial numbers can be found on the sterile package and on the Y-connector at the end of the percutaneous driveline.

Thoratec is recommending that these IVADs not be placed in the external position. Patients who already have them in this position should be instructed to contact their doctors immediately. Additional information can be obtained from the company by calling 1-800-528-2577. Note that the recall does not affect IVADs that are implanted within the patient's body.

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January2008FDA Patient Safety News Homepage
Ongoing Safety Review of Maxipime (Video, print, and e-mail functions)
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FDA has notified healthcare professionals about a recent study that raises the possibility of an increased risk of death among patients taking cefepime, which is marketed as Maxipime. The study, reported in the journal, The Lancet Infectious Diseases, is a meta-analysis that shows a significant difference in mortality from all causes when Maxipime is compared with other beta-lactam antibiotics.

This notification is part of FDA's commitment to inform people about safety evaluations of drugs in their early stages, in some cases before new findings are fully confirmed and before their clinical significance is established.

In this case, FDA is working with the manufacturer of Maxipime to further evaluate the study's findings, and has requested additional data on the mortality risk associated with this drug. As soon as this evaluation is finished, FDA will make the findings known.

In the meantime, prescribers who are considering using Maxipime should be aware of the risks and benefits described in the prescribing information, and the new information from this meta-analysis.

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 Preventing Medical Errors

January2008FDA Patient Safety News Homepage
Avoiding Hazards from Using Cleaners and Disinfectants on Electronic Medical Equipment (Video, print, and e-mail functions)
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FDA, CDC, EPA and OSHA have issued a Public Health Notification on how to avoid hazards when using liquid cleaners and disinfectants on electronic medical equipment. The Notification covers a wide range of equipment, including infusion pumps, ventilators, analgesia pumps, computer workstations and monitoring equipment.

This action was prompted by reports of fires and other equipment damage, as well as burns to healthcare workers, when these types of liquids were used inappropriately on equipment that has unsealed electrical circuits. In many cases, healthcare workers routinely sprayed the equipment with disinfectants or wrapped the housings with disinfectant-soaked towels, causing damage to the circuitry.

The Notification provides a number of recommendations to reduce the risk. Here are some of the highlights:

• Protect equipment from contamination during use, which can help avoid the need for disinfection.

• If equipment becomes contaminated, remove it from use and be sure it's serviced before returning it to use.

• Clean equipment surfaces according to the instructions from both the equipment manufacturer and the chemical manufacturer.

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January2008FDA Patient Safety News Homepage
What to Do about Unretrieved Device Fragments (Video, print, and e-mail functions)
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A recent FDA article in the journal Nursing2007 alerts healthcare personnel about the potential dangers posed by fragments of medical devices that are left in a patient's body. FDA receives more than a thousand reports each year of device fragments breaking off during invasive procedures or from devices already implanted in the body. The fragments may have been left in the body because they could not be retrieved or because the risk of removing them was greater than the risk of leaving them in place.

Many of these reports involve fragments of catheters and guidewires that are left in the patient's body, and some have caused death. In one case, a patient died from cardiac tamponade after a fractured guide wire lodged in a coronary artery and could not be removed.

The article also points out that metallic fragments in the patient's body can move or become heated during MRI exams, and if the fragment is near a vital organ or blood vessel, this can cause injury.

Several dangerous techniques can increase the likelihood of device breakage, such as using too much force during insertion or withdrawal, bending a device to conform to the patient's anatomy, and using old or worn devices.

The article lists several steps healthcare personnel can take to minimize the risks associated with unretrieved device fragments. Here are some of them:

• Make sure that the presence of the fragments is noted in the patient's record.

• Let patients know about any device fragments they may have, and instruct them to report this to other caregivers in order to avoid future complications during testing or treatment.

• When treating a patient, ask about a history of unretrieved device fragments.

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