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U.S. Department of Health and Human Services

Show #91, October 2009

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Show #91, October 2009

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 New Medical Products

October2009FDA Patient Safety News Homepage
New Colchicine Product and Dosing Regimen (Video, print, and e-mail functions)
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FDA has approved the first single-ingredient oral colchicine product. The drug, called Colcrys, is approved to treat acute gout flares and familial Mediterranean fever. Oral colchicine has been used to treat gout in the past, but until now it had not been approved by FDA.

Colchicine has historically been given every hour for acute gout flares, either until the flare subsided or treatment had to be stopped because the patient developed gastrointestinal problems. But a dosing study conducted as part of the approval of Colcrys demonstrated that one initial dose and a single additional dose after one hour was just as effective and much less toxic. Healthcare professionals should use this lower recommended dosing regimen to treat acute gout flares.

Healthcare professionals should also be aware that colchicine interacts with other drugs, including P-glycoprotein and strong CYP3A4 inhibitors such as cyclosporine and clarithromycin. This can lead to serious or even fatal colchicine toxicity, particularly if a patient has renal or hepatic impairment. And so concomitant use of colchicine and P-glycoprotein or strong CYP3A4 inhibitors is contraindicated in these patients. For patients with normal renal and hepatic function, consider interrupting colchicine therapy or reducing the dose if the patient needs treatment with a P-glycoprotein or a strong CYP3A4 inhibitor.

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 Recalls and Safety Alerts

October2009FDA Patient Safety News Homepage
Potentially Fatal Errors with Certain Glucose Test Strips (Video, print, and e-mail functions)
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FDA is warning again that potentially fatal glucose monitoring errors can occur in patients who receive therapeutic products containing certain sugars other than glucose. These products include oral xylose, intravenous infusions that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin, such as Extraneal. A more specific product list can be found below.

The problem is that some glucose meters use a type of test strip (GDH-PQQ) that cannot distinguish between glucose and these other sugars, so the reading on one of these test strips will reflect both the patient's actual blood glucose and the other sugar the patient received. These falsely elevated readings can mask significant hypoglycemia, or they can lead to excessive insulin administration. This can result in severe hypoglycemia, coma and death. Other glucose test strip methodologies are not affected by the presence of non-glucose sugars.

FDA has received 13 reports of deaths associated with GDH-PQQ test strips that had documented interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities. Ten of the 13 patients were receiving Extraneal peritoneal dialysis solution for renal failure. Three of the 13 patients were receiving maltose-containing substances. Patients were treated with insulin doses or insulin drips that were guided by falsely elevated blood sugar results. Six of the 13 deaths have occurred since 2008, despite previous warnings from FDA and others.

FDA is now recommending that healthcare facilities avoid using GDH-PQQ glucose test strips, which include several types of ACCU-CHEK, TRUEtest and Freestyle test strips.

If a facility does use GDH-PQQ test strips, FDA recommends additional precautions:

• Determine whether patients are receiving products that contain other sugars when they are admitted and periodically during their stay at the facility.

• If patients are receiving one of these interfering products, never use GDH-PQQ test strips to monitor their blood glucose. Instead, use only laboratory-based glucose assays. This also holds true for patients who are unresponsive or cannot communicate adequately.

• Educate the staff about this potentially fatal problem, and consider safeguards such as drug interaction alerts in computer order entry systems, patient profiles and charts. And for patients who are not receiving interfering products, periodically verify glucose meter readings with laboratory-based results.

FDA is working with glucose monitoring manufacturers to address problems with GDH-PQQ glucose test strips, and will continue to monitor adverse events associated with these products.

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October2009FDA Patient Safety News Homepage
Certain Lots of Teva Propofol Recalled (Video, print, and e-mail functions)
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Teva Pharmaceuticals is recalling certain lots of Propofol Injectable Emulsion 10 mg/mL because some of the vials in these lots contain elevated endotoxin levels.

The company says that it has received over 40 reports of patients treated with propofol who experienced fever, chills and other flu-like symptoms post-operatively. Based on available information, these febrile or flu-like reactions were self-limited and spontaneously resolved. However, patients exposed to high endotoxin levels could experience serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death.

The recall affects lot numbers 31305429B and 31305430B, which contain 100 mL vials. Anyone with propofol from these lots should not use it and return it to the distributor. For more information, contact Teva Pharmaceuticals at 1-866-262-1243.

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October2009FDA Patient Safety News Homepage
Alaris (Medley) Infusion Systems Recalled (Video, print, and e-mail functions)
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CareFusion is alerting healthcare professionals about a number of safety problems with several models of Alaris infusion systems. These problems could cause patients to be over or under-infused, which could lead to serious injury or death.

Certain units of the following Alaris devices are affected:

• Point-of-care Units, Models 8000 and 8015

• Pump Module, Model 8100

• Patient-Controlled Analgesia Module, Model 8120

• Inter-Unit Interface Connectors for the Alaris System

These devices were formerly sold under the "Medley" name.

The company notified customers about these potential problems in June, and described its plans to provide software and hardware corrections over the next several months. Until then the company's notice advises pump users to take certain steps to mitigate the problems.

For example, one failure can affect the Alaris PC unit when it is used with the PCA module. The pump is supposed to verify that the volume of medication in the syringe will deliver the infusion that is programmed. But if the infusion rate exceeds the volume of therapy in the syringe, a warning is displayed. If the pump user confirms the infusion and the patient presses the button on his handset to deliver medication, the pump may deliver the entire contents of the syringe to the patient, which could cause serious injury or death.

The company says that if the syringe volume warning appears, you must first take the dose request handset from patients to keep them from pressing the button. Then, press the “CONFIRM” key, then the “PAUSE” key to halt the infusion. Remove the syringe, verify the concentration, and reprogram the infusion. Do not return the handset to the patient until you have reprogrammed the infusion and confirmed that it's been programmed properly.

Another example involves the possible failure of the circuitry that protects against electrostatic discharge in certain Alaris PC units. Because of this, there could be problems with the entry keypad, including the possibility that the keypad could not respond to key presses, or that key entries could register incorrectly or could occur without keys being pressed. Pump users should always verify the drug name, concentration, and programmed infusion parameters before starting an infusion. If a keypad does not perform correctly, take the pump out of service and return it to the company.

You can get more information about the Alaris System recall by calling the CareFusion recall center at 888-562-6018.

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October2009FDA Patient Safety News Homepage
Recall of Certain Hospira Devices (Video, print, and e-mail functions)
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Hospira, Inc. has issued an alert about a number of the company's medical devices that have defective AC power cords. These devices include infusion pumps, compounders, monitoring devices and printers.

This action comes after reports of sparking, charring and fires on the plug of the power cord. Hospira has determined that the power cord's prongs may crack and fail at or inside the plug. That could lead to fire, electrical shock, device failure, and interference with therapy. Depending on the device and the type of therapy, these failures could cause potentially serious injury or death.

Hospira is working with its customers to replace the power cords on all the affected devices, regardless of their condition. The complete list of these devices can be found below.

In the meantime, Hospira is advising users of the affected devices to inspect their power cords. The defective cords have a prong and ground-pin insert design, with a black plastic bridge connecting the terminal prongs on the plug. Devices with power cords that don't have this black bridge connecting the terminal prongs are not affected.

Anyone who finds a cord with bent or cracked prongs, burnt plastic, or excessive wear and tear should immediately stop using the device and contact Hospira to find out how to get replacement parts or devices. The company can be contacted at 1-800-241-4002. Power cords that don't show any of these potentially dangerous characteristics should be monitored regularly until they can be replaced.

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October2009FDA Patient Safety News Homepage
“Nuby” Gel-filled Teethers Recalled (Video, print, and e-mail functions)
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Parents and other caregivers of small children should be aware that the company Luv N' Care Ltd. has recalled almost 20 styles of gel-filled teethers because they might be contaminated with bacteria.

The gel inside these teethers may contain Bacillus subtilis and Bacillus circulans. Adults exposed to these bacteria generally do not get sick. However, if the teether is punctured and infants or children with weakened immune systems ingest the gel containing these bacteria, they could suffer stomach pain, vomiting, diarrhea, and occasionally more serious disease.

The recall affects 15 styles of gel-filled teethers sold under the brand name "Nuby", two sold under the "Cottontails" name and one sold under the "Playskool" name. UPC codes for these styles can be found below. Consumers who have these teethers should stop using them immediately and either throw them away or return them to the place of purchase for a refund. For questions, contact the company at 1-800-256-2399, ext. 3106.

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October2009FDA Patient Safety News Homepage
Safety Warning on Certain Body-building Products (Video, print, and e-mail functions)
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11/4/09 UPDATE - Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company's website, www.bodybuilding.com.

FDA is warning the public not to use body-building products that claim to contain steroids or steroid-like substances, because they can cause serious health problems. These products, which are sold online and in retail stores, are promoted as alternatives to anabolic steroids for increasing muscle mass and improving sports performance. Although these products are often marketed as dietary supplements, they are actually unapproved new drugs containing synthetic steroids or steroid-like substances that have not been reviewed for safety and effectiveness by the FDA.

FDA has received reports of serious injuries associated with these products, including liver damage, stroke, kidney failure and pulmonary embolism. It is also known that products containing anabolic steroids can cause a variety of long-term effects, including shrinkage of the testes, infertility and breast enlargement in men, masculinization in women, and short stature in children. They can also produce adverse effects on blood lipids, with increased risk of heart attack and stroke.

FDA has sent a warning letter to American Cellular Laboratories, a company that has marketed these body-building products under a number of brand names. A list of these products can be found below. FDA is also gathering additional information about other products that claim to contain steroids or steroid-like substances.

FDA recommends that healthcare professionals ask patients about their use of any over-the-counter products, including supplements, and that they be alert to patients presenting with the warning signs of steroid use.

Consumers should immediately stop taking any product that claims to contain steroids or steroid-like substances, or to have hormone-like effects in the body. They should seek medical attention if they experience symptoms that might be associated with these products, including nausea, weakness, fatigue, fever, abdominal or chest pain, shortness of breath, jaundice, or discolored urine.

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