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U.S. Department of Health and Human Services

Show #97, April 2010

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Show #97, April 2010

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 Recalls and Safety Alerts

April2010FDA Patient Safety News Homepage
Caution on Zyprexa in Adolescents (Video, print, and e-mail functions)
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The FDA is recommending that healthcare professionals use caution when considering Zyprexa (olanzapine) for treating adolescents 13 to 17 years old for schizophrenia and bipolar disorder.

Physicians, patients and caregivers should understand that adolescents may experience weight gain and hyperlipidemia with Zyprexa. In fact, they have a greater risk of these effects than adults. They are likely to gain more weight than adults and have greater increases in total cholesterol, LDL cholesterol, triglycerides, prolactin, and hepatic transaminase levels. Adolescents are also more likely to experience sedation than adults. Clinicians should take these effects into account when deciding on antipsychotic medications for adolescents, and they may want to consider trying other drugs first.

If Zyprexa is prescribed for adolescents, it should be part of a comprehensive treatment program that often includes psychological, educational and social components. It is also important to note that Zyprexa has not been approved for patients under the age of 13.

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April2010FDA Patient Safety News Homepage
Certain Powerheart/CardioVive/CardioLife AED Recalled (Video, print, and e-mail functions)
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In February, Cardiac Science Corporation initiated a recall of several models of automated external defibrillators because manufacturing problems may make them susceptible to failure. If that happens, they might not be able to deliver therapy during a resuscitation attempt, and that could lead to serious adverse health consequences or death.

The company says this action affects more than 12,000 AEDs manufactured or serviced between October 19, 2009 and January 15, 2010 with the following model numbers:

• Powerheart G3 Series, models 9300A, 9300E, 9300P, 9390A, and 9390E

• CardioVive model 92532 and

• CardioLife models 9200G and 9231

Anyone who has one of the recalled devices should take it out of service immediately because it might fail to deliver therapy. Contact Cardiac Science to get a replacement at 1-888-402-2484.

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April2010FDA Patient Safety News Homepage
Recall of Q-Syte Luer Access Devices (Video, print, and e-mail functions)
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Here's an alert about certain lots of Q-Syte Luer access devices. These are split -septum needleless valves used with other infusion therapy products to administer IV fluids. The Q-Syte devices are sold by themselves and are also sometimes packaged with other devices as part of systems or kits, including certain IV and central venous catheter sets.

Becton Dickinson, the manufacturer of the Q-Syte device, initiated a recall of certain lots in October 2009 because of complaints of air entering through the bottom disk of the device's septum. Using the recalled devices may cause an air embolism or may cause blood or therapy fluids to leak, which could result in serious injury or death. After investigating the complaints, the company determined that a manufacturing deviation was the cause of the problem.

The company says that the recalled Q-Syte devices were distributed worldwide from November 2008 through November 2009. Certain catalog and lot numbers of the following kits and systems are also being recalled because they contain the affected Q-Syte devices.

To date, these include:

• Nexiva Closed IV Catheter Systems sold by BD

• IV Extension Sets sold by Acacia Inc.

• Central Venous Catheter Kits sold by Arrow International

• IV kits sold by Medical Action Industries

Several million units are affected. Anyone who has the affected devices should not use them, remove them from inventory and contact the company.

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April2010FDA Patient Safety News Homepage
Cardiovascular Risk with Meridia (Video, print, and e-mail functions)
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FDA is alerting healthcare professionals that Meridia (sibutramine) is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Meridia is used to manage obesity.

In November 2009, an early communication from FDA reported preliminary study results suggesting that patients on Meridia had a greater frequency of cardiovascular events than those not taking the drug. Additional data from the study has shown that the excess risk occurred in patients with a history of cardiovascular disease.

Based on this information, Meridia is now contraindicated in patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack (TIA), cardiac arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled hypertension. Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using Meridia and discontinue the drug if there are sustained increases in these measurements.

They should also discontinue Meridia in patients who do not lose at least 5 percent of their baseline body weight within the first three to six months of treatment, because further treatment is not likely to be effective and exposes the patient to unnecessary risk. Patients using Meridia should talk with their healthcare professional about whether to continue using the drug.

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April2010FDA Patient Safety News Homepage
SafeSheath CSG Hemostatic Introducer Recalled (Video, print, and e-mail functions)
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Thomas Medical Products Inc. has recalled the SafeSheath Coronary Sinus Guide Introducer. This device is a hemostatic introducer system with an infusion side port that's used to insert various types of pacing or defibrillator leads.

The company is recalling these products because the soft radiopaque tip may fracture while the lead is being implanted and leave fragments in a patient's vasculature, which could embolize. The company has received over three dozen reports of these fractures to date.

The recall covers products distributed from December 1, 2005 to December 14, 2009; the company initiated the recall in December 2009. Anyone who has the recalled devices should segregate them to ensure they won't be used. Contact Thomas Medical to arrange for return and replacement at 1-866-466-3303.

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April2010FDA Patient Safety News Homepage
Measuring Rapamune Blood Concentrations (Video, print, and e-mail functions)
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Wyeth is cautioning healthcare professionals about therapeutic drug monitoring for Rapamune (sirolimus). Rapamune is used to prevent organ rejection in certain renal transplant patients.

The company points out that Rapamune blood concentrations can be assayed using either chromatographic or immunoassay tests, and that the results of these two methodologies are not interchangeable. If the assay method were switched during a patient's treatment with Rapamune, the dose of the drug might be adjusted improperly - too low a dose could lead to allograft rejection, and too high a dose could expose the patient to toxic side effects.

Wyeth is advising clinicians who manage patients on Rapamune to determine which assay is used in their laboratory, if there has been any change in the assay or in the laboratory's reference range, and if the institution or referring center has changed its recommended range. The bottom line is that it is critical for clinicians to communicate with their laboratories about any changes in the assays used to measure blood concentrations in Rapamune patients.

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April2010FDA Patient Safety News Homepage
Plastic Rotors for Hettich Centrifuges Recalled (Video, print, and e-mail functions)
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Hettich Instruments has recalled the plastic hematocrit rotors used with some of the company's centrifuges. These rotors may crack apart and explode through the centrifuge housing, which could be a safety hazard. There's been one report where a rotor broke apart and destroyed the centrifuge housing. Although no one was hurt, the projectiles from the explosion caused damage in the surrounding area.

The recall affects plastic rotor models 2050 and 2076 that are used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. Model numbers are stamped on the rotors.

In November 2009, Hettich notified its customers about the recall. Hospitals, clinics and laboratories that have these products should stop using them and contact the company to replace the plastic rotors with metal ones. For more information call Hettich at 1-866-370-4388.

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April2010FDA Patient Safety News Homepage
Serious Liver Disorder with Videx (Video, print, and e-mail functions)
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FDA is notifying healthcare professionals about cases of a rare but serious complication, non-cirrhotic portal hypertension, in patients taking Videx (didanosine) or Videx EC, to treat HIV infection.

Clinicians should monitor patients on Videx for portal hypertension and esophageal varices. They should also be aware that Videx has been associated with other hepatic effects, including lactic acidosis, hepatomegaly with steatosis, and liver failure.

FDA believes that for certain patients, the clinical benefits of Videx continue to outweigh its risks, and that the decision to use the drug must be made on an individual basis.

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April2010FDA Patient Safety News Homepage
GlucoPro Insulin Syringes Recalled (Video, print, and e-mail functions)
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Nipro Medical Corporation has recalled the company's GlucoPro insulin syringes because the needle may detach from the syringe. If that happens, the needle could get stuck in the insulin vial, or get pushed back into the syringe, or even stay in the skin after injection.

According to a company press release issued in January, the recall covers all product codes and lot numbers with expiration dates before November 1, 2011. It does not apply to GlucoPro syringes that are specified for use with Nipro's Amigo insulin pump. Anyone who has the recalled syringes should stop using them and return them to point of sale for reimbursement. For more information call 305-599-7174 Ext. 249.

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 FDA Consumer Corner

April2010FDA Patient Safety News Homepage
Potentially Fatal Salmonella Infections from Pet Turtles (Video, print, and e-mail functions)
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Turtles may look like cute pets, but they could be responsible for over 70,000 cases of salmonella infections every year in this country. Turtles commonly carry the Salmonella bacteria, and although the turtle doesn't get sick, people can become very ill if they're exposed to a contaminated turtle. You don't even need to touch a turtle to become infected, because turtles shed the bacteria into their water and housing.

For example, a four week-old infant died of a Salmonella infection that was traced to a pet turtle in the home. In another case, two teenage girls became very ill after they swam in an unchlorinated family pool where pet turtles had been allowed to swim.

Because of these concerns, FDA is warning people about the danger of having turtles as pets. FDA's warning applies to young children, whose immune systems may be less able to resist infection. Also, young children are likely to handle the turtles, and then handle food or touch their mouths, and of course that increases the chance of taking in the bacteria. But FDA's warning isn't just about children. People with weakened immune systems, the elderly and pregnant women are also at high risk.

Here's what FDA is recommending:

• Don't buy small turtles as pets or as gifts. You can prevent the problem completely that way.

• If you already have a pet turtle, here are some things you can do to minimize the risk of illness. If your family is expecting a child, remove the animal from the home before the baby arrives. Keep turtles out of homes with children under five, the elderly, or those with weakened immune systems. Always wash hands thoroughly with soap and water after touching the turtle or any object it's come in contact with. Use bleach to disinfect the area where the turtle tank is cleaned, and don't clean turtle tanks or other supplies in the kitchen sink. Be aware that children can contract Salmonella infections from turtles in petting zoos, parks, classrooms and daycare facilities. And watch for symptoms of Salmonella infection, such as diarrhea, abdominal pain, nausea, vomiting, fever and headache, and call your doctor if these occur.

The bottom line is that thousands of turtle-related Salmonella cases each year are totally preventable, simply by not buying these animals, and not bringing them into your home.

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