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U.S. Department of Health and Human Services

Show #74, April 2008

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Show #74, April 2008

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 New Medical Products

April2008FDA Patient Safety News Homepage
Decellularized Allograft Heart Valve Approved (Video, print, and e-mail functions)
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FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed. It is called the CryoValve SynerGraft Pulmonary Heart Valve, and is manufactured by CryoLife, Inc.

Allograft valves are recovered from cadavers. Traditionally they are inspected, cleaned and decontaminated, but other than that, they are left unchanged. With the new valve, cells are removed during the manufacturing process. What's left is a scaffold of connective tissue that still functions like a human heart valve, but may be less likely to trigger an immune response and tissue rejection.

Clinical studies on the SynerGraft valve found that it performed at least as well as traditional CryoLife allograft valves with respect to mortality, re-operations, endocarditis, and blood clots.

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 Recalls and Safety Alerts

April2008FDA Patient Safety News Homepage
Fentanyl (Duragesic) Patches Recalled (Video, print, and e-mail functions)
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UPDATE: On March 3, 2008 Actavis recalled all remaining lots of Fentanyl transdermal patches as a precautionary measure. This is an expansion of Actavis’s February 2008 recall of fourteen lots of Fentanyl patches. For more details, see “Additional Information” below.

Several brands of fentanyl transdermal patches are being recalled because they may have defects that could allow the fentanyl gel to leak out of the patch. If the gel touches patient's or caregiver's skin, it could cause respiratory depression and possibly death.

One recall affects all U.S. lots of 25 mcg/hr Duragesic patches sold by PriCara, and its generic equivalent sold by Sandoz. All these patches are manufactured by the ALZA Corporation and have expiration dates of December 2009 or earlier. Anyone who has the recalled Duragesic patches should call 800-547-6446 for instructions on how to return them. Those who have the recalled Sandoz fentanyl patches should call 800-901-7236.

The second recall affects over a dozen lots of Actavis fentanyl patches in all strengths. [See UPDATE above.] Note that the pouch containing the fentanyl patch may have an Abrika Pharmaceuticals label, whereas the outer carton has the Actavis logo. Lot numbers can be found under "Additional Information" below. Anyone who has Actavis patches from the recalled lots should call 1-877-422-7452 for information on how to return them.

If you have a defective patch, dispose of it immediately by flushing it down the toilet, but be sure not to handle it directly. Anyone who comes in contact with fentanyl gel should rinse the exposed skin thoroughly with water. Do not use soap, because this could increase the drug's absorption through the skin.

As a reminder, fentanyl is a very strong opioid narcotic. The patches should only be used by opioid-tolerant patients with chronic pain that is not well-controlled by other shorter-acting analgesics.

In addition, patients and caregivers should be educated about the signs and symptoms of fentanyl overdose, which include respiratory distress, shallow breathing, fatigue, sleepiness, confusion, dizziness and fainting. And be sure that patients understand how to use the patches properly, including how often to apply the patch, reapplying a patch that's fallen off, replacing a patch, and disposing of the patch.

Finally, remember to tell patients that heat can increase absorption of the drug to dangerous levels, and so they should avoid heating pads, electric blankets, hot baths, sunbathing and other heat sources while the wearing the patch. And they should be cautioned to contact their doctor immediately if they develop a temperature above 102 degrees.

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April2008FDA Patient Safety News Homepage
New Safety Warnings about Chantix (Video, print, and e-mail functions)
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FDA is alerting healthcare professionals about new safety warnings for Chantix (varenicline), a drug used to help people stop smoking.

Chantix has been linked to serious neuropsychiatric problems, including changes in behavior, agitation, depressed mood, suicidal ideation and suicide. The drug may cause an existing psychiatric illness to worsen, or an old psychiatric illness to recur. The symptoms may occur even after the drug is discontinued.

People who are trying to give up smoking often experience mood swings, irritability and other changes in behavior. But as the reports accumulate, it becomes clearer that there is a link with the drug. For example, some of the patients who experienced these psychiatric symptoms hadn't actually quit smoking.

Physicians and patients have to make an informed decision about whether Chantix is suitable, but in order to do that, it's important that they exchange some important information. For example, physicians should inquire about past psychiatric illnesses before they prescribe Chantix, and patients should be educated to volunteer this information. The premarketing studies of Chantix did not include patients with serious psychiatric illnesses, so the safety of Chantix in these patients hasn't been established.

It is also important for everyone involved in the patient's care (including family members and caregivers) to be vigilant about changes in mood and behavior during the treatment. Things to watch out for include anxiety, nervousness, depressed mood, vivid or unusual dreams, and thinking about or attempting suicide. These changes should be immediately reported to the physician.

Patients should also know that the drug may impair their ability to drive or operate heavy machinery.

To help educate patients about all of these issues, FDA is working with Pfizer, the manufacturer of Chantix, to develop a Medication Guide that will be dispensed with each prescription.

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April2008FDA Patient Safety News Homepage
Early Communication on Adverse Events from Botox and Myobloc (Video, print, and e-mail functions)
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FDA has issued an early communication about serious adverse events, including respiratory failure and death, from Botox and Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B). These events were related to how the product was used, and not to a defect in the manufacturing process. The events occurred one day to several weeks after treatment, and from a wide range of dosages.

In the affected patients, the botulinum toxin may have spread beyond the injection site and caused symptoms associated with botulism, including dysphagia and respiratory insufficiency. The most severe effects were seen in children, and the most commonly reported use in children was for limb spasticity in cerebral palsy, which is an unapproved use. Adverse reactions also occurred in patients receiving the drug for approved indications.

FDA is evaluating all the adverse event reports, as well as the medical literature in this area, and will let health professionals and the public know about any new information or conclusions.

In the meantime, healthcare professionals who use botulinum toxins should be alert to the potential for systemic effects from local injections, including dysphagia, dysphonia, weakness, dyspnea, or respiratory distress. They should tell patients and caregivers about the symptoms of botulism and to seek immediate medical attention if they occur.

Finally, practitioners should understand that the potency of botulinum toxin, which is expressed in "Units" ("U"), is not comparable from one botulinum toxin product to the next.

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April2008FDA Patient Safety News Homepage
New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch (Video, print, and e-mail functions)
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The prescribing information for the Ortho Evra Contraceptive Transdermal Patch is being updated with results of a new study on the risk of venous thromboembolism. This study found that women aged 15-44 who used the birth control patch were at higher risk of developing venous thromboembolism than women using birth control pills.

These findings support an earlier study that also concluded that women in this group were at higher risk of venous thromboembolism. Another earlier study found that women using the patch did not have a greater risk.

However, the results from the two positive studies support concerns that the patch could increase the risk of blood clots in some women. The label continues to recommend that women with concerns or risk factors for thromboembolic events talk with their healthcare provider about using Ortho Evra versus other contraceptives.

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 Preventing Medical Errors

April2008FDA Patient Safety News Homepage
Remembering to Re-Activate a Patients’s Defibrillator (Video, print, and e-mail functions)
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A recent FDA article in the journal "Nursing2008" describes the case of a patient who died, possibly of ventricular fibrillation, following elective surgery. This happened because after the procedure, his implantable cardioverter defibrillator (ICD) wasn't reactivated.

ICDs are subject to interference from MRI and CT machines, and also from sources such as electrocautery devices. This interference can cause inappropriate shocks to the patient, and so ICDs are often turned off prior to medical and surgical procedures. But unless they're turned back on immediately afterwards, the patient will be unprotected against potentially lethal arrhythmias.

To prevent these kinds of errors, here's what the article recommends:

• Document information about the patient's ICD in the medical record.

• As the patient moves through the system, be sure other personnel know that the patient has an ICD and whether it is on or off.

• While the ICD is inactivated, provide continuous cardiac monitoring and have emergency equipment close by.

• Ensure that the ICD is reactivated after the medical or surgical procedure is finished.

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April2008FDA Patient Safety News Homepage
Mixups between Insulin U-100 and U-500 (Video, print, and e-mail functions)
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The Institute for Safe Medication Practices (ISMP) recently described an increase in reports about mixups between insulin U-100 and insulin U-500. These errors could result in dangerous hyperglycemia or hypoglycemia. Mistakes have occurred when prescribers accidentally selected U-500 regular insulin from computer screens instead of U-100.

ISMP has identified several possible reasons for these kinds of errors. For example, sometimes the two dosage forms appear one line apart on the screen, which makes it easy to select the wrong one. Also, depending on the screen size, the prescriber may see only the first few words of the product listing, so the drug concentration may not be visible. And finally, since the use of U-500 insulin is not common at present, prescribers may just assume that the only regular insulin that's available is U-100 and not even look for the concentration on the screen. ISMP suggests that the use of U-500 insulin may be increasing due to the higher prevalence of obesity, the use of insulin pumps, and tight glucose control protocols in hospitalized patients.

ISMP says that the major suppliers of drug information systems have agreed to add the word "concentrated" on their selection screens, immediately following the drug name and preceding "U-500", which should help solve the problem. Until these updates appear in your system, here's what ISMP recommends.

• If U-500 isn't commonly used in your facility, consider listing it differently from other insulins, so it doesn't appear on the same screen as other insulin products.

• Consider adding a hard stop to all orders for U-500. This requires prescribers and pharmacists verify that the patient should be getting the U-500.

• Pharmacies should consider not stocking U-500 if they don't have patients who use it.

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 Advice for Patients

April2008FDA Patient Safety News Homepage
Caution Giving Children Cough and Cold Medicines (Video, print, and e-mail functions)
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FDA is cautioning parents and caregivers about giving their children cough and cold medicines.

FDA strongly recommends that cough and cold medicines NOT be given to children younger than 2 years old because serious and potentially life-threatening side effects can occur, including convulsions, rapid heart rates, decreased levels of consciousness and death.

FDA is currently reviewing the use of these medicines in children aged two to 11. While the review is being completed, here are some recommendations for parents and caregivers if they give cough and cold medicines to children two and older:

• Understand that these medicines won't cure or shorten the duration of the common cold. They're just intended to relieve symptoms.

• Be sure to follow the dosing directions on the label.

• Check the "Drug Facts" label to learn which active ingredients are in the products. Using two medicines that have the same or similar active ingredients could give a child too much of that drug.

• Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs. Otherwise, the wrong amount could be given.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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