Recall Notice: Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results
(including Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, ReliOn Ultima)
On December 22, 2010, The FDA and Abbott Diabetes Care issued a recall notification to healthcare professionals and patients regarding the recall of 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima. The issue relates to the insufficient absorption of blood into the test strip. Test strips included in the recall may give falsely low blood glucose results, which can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading. The recalled test strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The test strips, which were manufactured between January and May 2010, are sold both in retail and online settings directly to consumers, but are also used in health care facilities. Patients with diabetes should be aware of this problem and take steps to prevent it from affecting their health. Customers can check if they have tests trips from the recalled lots by visiting Abbott’s website to look up their product lot number: http://www.precisionoptiuminfo.com/. Click here for more information.

Recall Notice: B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag

On November 30, 2010, B Braun Medical Inc. issued a reiteration of a prior June 28, 2010 recall on use of its addEASE Binary Connectors. The organization identified that when an addEASE Binary Connector is inserted into a partial additive bag (PAB) stopper, fragments of the stopper may enter the bag, resulting in a small amount of visible particles in the solution. These particles can potentially enter a patient’s body and lead to serious injury and/or death. It is recommended that anyone currently using this product discontinue doing so immediately. Click here for more information.

Recall Notice: Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

On November 15, 2010, the FDA and Sigma International Gerneral Medical Apparatus, LLC reiterated an earlier recall notice from September 15, 2010 regarding Sigma Spectrum Infusion Pump Model 35700. The recall includes pumps that have serial numbers from 706497 to 724065. The recall was issued because these units may fail suddenly, causing inaccurate flow conditons during use, ranging from back flow to over-infusion, including free flow. Also, of concern in that the pump does not issue and alarm when this occurs which could result in the serious injury of death of the user.

Should you be in possession of a recalled pump, Sigma is requiring the return of the devices. For questions and return information please, contact the company at 1-866-482-2893, Monday through Friday, 8 AM though 5 PM (Eastern Time). Click here for more information.

Recall Notice: Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem

On October 8, 2010, WalkMed Infusion LLC. and the FDA notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500 and serial numbers TR1401 through TR 2559, manufactured and sold before June 2010. The issue stems from a problem with the latch alarm on the pump door which if gone unnoticed could potentially lead to an over infusion of medication to the patient. It is requested that consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer. Click here for more information.

Recall Notice: Heparin Sodium (B. Braun): Recall - Trace Contaminant

On October 29, 2010, B. Braun Medical Inc. and the FDA notified healthcare professional of a nationwide recall of certain lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010. Should you be in possession of this product discontinue use immediately. To identify product lot numbers, expiration dates, and further recall instructions, please reference the Recall Notice contained in the following link. Click here for more information.

FDA Proposes Withdrawal of Low Blood Pressure Drug: Companies failed to provide evidence of clinical benefit of midodrine hydrochloride

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.

The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.

To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.

Orthostatic hypotension is a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up.

Generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories. According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009.

Access the FDA information at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm

Disasters, crush syndrome, and acute kidney injury to be featured at Renal Week 2010: Denver, CO

In a terrorist attack, crush injury and crush syndrome may result from structural collapse after a bombing or explosion. Crush injury is defined as compression of extremities or other parts of the body that causes muscle swelling and/or neurological disturbances in the affected areas of the body. Typically affected areas of the body include lower extremities (74%), upper extremities (10%), and trunk (9%). Crush syndrome is localized crush injury with systemic manifestations. These systemic effects are caused by a traumatic rhabdomyolysis (muscle breakdown) and the release of potentially toxic muscle cell components and electrolytes into the circulatory system. Crush syndrome can cause local tissue injury, organ dysfunction, and metabolic abnormalities, including acidosis, hyperkalemia, and hypocalcemia.

Previous experience with earthquakes that caused major structural damage has demonstrated that the incidence of crush syndrome is 2-15% with approximately 50% of those with crush syndrome developing acute renal failure and over 50% needing fasciotomy. Of those with renal failure, 50% need dialysis.

-Centers for Disease Control and Prevention
http://www.bt.cdc.gov/masscasualties/blastinjury-crush.asp

Nephrology in Natural Disasters: What to Do with Acute Kidney Injury and End-stage Renal Disease Patients during Disasters
November 19, 2010 | 04:30 PM - 06:30 PM
Presented by the American Society of Nephrology – Renal Week 2010
Denver, Colorado

Session Description
This topic serves to educate physicians living in at-risk areas about how to respond to a natural disaster, prepare a dialysis unit, assess nephrology needs (e.g., continue chronic dialysis for existing patients, need for acute dialysis for acute kidney injury patients), how to respond appropriately to minimize renal injury, how to manage crush victims following disasters, and complications. The International Society of Nephrology (ISN) has spearheaded these efforts with the Renal Disaster Relief Task Force. ASN recently developed its own task force. The merging of experience may be of great value to the physicians from many countries who attend the Renal Week.

Session Objectives
Upon completion of this session, the participant will be able to: be better equipped to develop algorithms for: 1) evacuation; 2) recognizing and forming support networks; and 3) treatment plan for renal patients.

Moderators
Jeffrey B. Kopp, MD, FASN
Ricardo Correa-Rotter, MD

Lectures
Nephrology Experience in Natural Disasters
04:30 PM - 05:00 PM

Impact of Disasters on Dialysis Patients' Health
05:00 PM - 05:30 PM
Kenneth D. Lempert, MD

Haiti Earthquake from a Nephrology Point of View
05:30 PM - 06:00 PM
Didier Portilla, MD

Recommendations for the Management of Crush Victims Following Mass Disasters
06:00 PM - 06:30 PM
Raymond C. Vanholder, MD, PhD

Please see the registration information at http://www.asn-online.org/education_and_meetings/renal_week/2010/program-session-details.aspx?sess_id=36

NOAA Still Expects Active Atlantic Hurricane Season; La Niña Develops

The Atlantic Basin remains on track for an active hurricane season, according to the scheduled seasonal outlook update issued today by NOAA’s Climate Prediction Center, a division of the National Weather Service. With the season’s peak just around the corner – late August through October – the need for preparedness plans is essential.

NOAA also announced today that, as predicted last spring, La Niña has formed in the tropical Pacific Ocean. This favors lower wind shear over the Atlantic Basin, allowing storm clouds to grow and organize. Other climate factors pointing to an active hurricane season are warmer-than-average water in the tropical Atlantic and Caribbean, and the tropical multi-decadal signal, which since 1995 has brought favorable ocean and atmospheric conditions in unison, leading to more active seasons.

“August heralds the start of the most active phase of the Atlantic hurricane season and with the meteorological factors in place, now is the time for everyone living in hurricane prone areas to be prepared,” said Jane Lubchenco, Ph.D., under secretary of commerce for oceans and atmosphere and NOAA administrator.

Across the entire Atlantic Basin for the whole season – June 1 to November 30 – NOAA’s updated outlook is projecting, with a 70 percent probability, a total of (including Alex, Bonnie and Colin):

• 14 to 20 Named Storms (top winds of 39 mph or higher), including:
• 8 to 12 Hurricanes (top winds of 74 mph or higher), of which:
• 4 to 6 could be Major Hurricanes (Category 3, 4 or 5; winds of at least 111 mph)

These ranges are still indicative of an active season, compared to the average of 11 named storms, six hurricanes and two major hurricanes; however, the upper bounds of the ranges have been lowered from the initial outlook in late May, which reflected the possibility of even more early season activity.

“All indications are for considerable activity during the next several months,” said Gerry Bell, Ph.D., lead seasonal hurricane forecaster at NOAA’s Climate Prediction Center. “As we’ve seen in past years, storms can come on quickly during the peak months of the season. There remains a high likelihood that the season could be very active, with the potential of being one of the more active on record.”

Be prepared for the hurricane season with important information available online at hurricanes.gov/prepare and at FEMA’s ready.gov.

NOAA’s mission is to understand and predict changes in the Earth's environment, from the depths of the ocean to the surface of the sun, and to conserve and manage our coastal and marine resources. Visit us on Facebook.

Tropical Depression 3

11am Eastern Time

A TROPICAL STORM WARNING HAS BEEN ISSUED FOR THE FLORIDA EAST COAST FROM GOLDEN BEACH SOUTHWARD INCLUDING THE ENTIRE FLORIDA KEYS AND FLORIDA BAY...AND ALONG THE WEST COAST OF FLORIDA NORTHWARD TO BONITA BEACH.

A TROPICAL STORM WATCH HAS BEEN ISSUED FOR THE EAST COAST OF FLORIDA
FROM NORTH OF GOLDEN BEACH TO JUPITER INLET INCLUDING LAKE
OKEECHOBEE.

SUMMARY OF WATCHES AND WARNINGS IN EFFECT...

A TROPICAL STORM WARNING IS IN EFFECT FOR...
* FOR THE FLORIDA EAST COAST FROM GOLDEN BEACH SOUTHWARD INCLUDING THE ENTIRE FLORIDA KEYS AND FLORIDA BAY...AND ALONG THE WEST COAST OF FLORIDA NORTHWARD TO BONITA BEACH

A TROPICAL STORM WATCH IN IN EFFECT FOR...
* THE EAST COAST OF FLORIDA NORTH OF GOLDEN BEACH TO JUPITER INLET INCLUDING LAKE OKEECHOBEE

A TROPICAL STORM WARNING MEANS THAT TROPICAL STORM CONDITIONS ARE EXPECTED SOMEWHERE WITHIN THE WARNING AREA WITHIN 36 HOURS.

A TROPICAL STORM WATCH MEANS THAT TROPICAL STORM CONDITIONS ARE POSSIBLE WITHIN THE WATCH AREA...GENERALLY WITHIN 48 HOURS.

FOR STORM INFORMATION SPECIFIC TO YOUR AREA IN THE UNITED STATES...INCLUDING POSSIBLE INLAND WATCHES AND WARNINGS...PLEASE MONITOR PRODUCTS ISSUED BY YOUR LOCAL NATIONAL WEATHER SERVICE FORECAST OFFICE. FOR STORM INFORMATION SPECIFIC TO YOUR AREA OUTSIDE UNITED STATES...PLEASE MONITOR PRODUCTS ISSUED BY YOUR NATIONAL METEOROLOGICAL SERVICE.

DHS Launches "See Something, Say Something" Campaign

Department of Homeland Secretary’s (DHS) Janet Napolitano launched the first phase of DHS' nationwide "See Something, Say Something" campaign and announced a new national information-sharing partnership with Amtrak as part of the Department's Nationwide Suspicious Activity Reporting (SAR) Initiative during a whistlestop train tour—highlighting the public's role in keeping our country safe and the Obama administration's commitment to bolstering surface transportation security.

"Implementing a national suspicious activity reporting partnership with Amtrak and expanding the 'See Something, Say Something' campaign strengthens our ability to guard against terrorism and crime," said Secretary Napolitano. "These initiatives enable us to provide frontline security personnel with the latest information and intelligence to recognize behaviors and indicators associated with new and evolving threats."

In the coming months, DHS will expand the "See Something, Say Something" campaign nationally with public education materials, advertisements and other outreach tools to continue engaging travelers, businesses, community organizations, and public and private sector employees to remain vigilant and play an active role in keeping our country safe.

In support of DHS’s “See Something, Say Something” Campaign, FEMA’s Individual and Community Preparedness Division has partnered with the International Association of Chiefs of Police (IACP) to research how to improve the public’s response to suspicious activity. FEMA and IACP plan to present on the research findings and recommendations at the IACP Annual Conference in late October.

Gulf of Mexico Oil Spill: is my drinking water safe?

Drinking Water

Is my drinking water safe?

Is my water safe to drink?
The oil spill is not currently expected to affect drinking water. The closest drinking water intake in use in Southeastern Louisiana on the Mississippi River is 49 miles upstream from the mouth of the river. The oil is not expect to migrate that far upstream. If you have any concerns about your water, contact your water utility.

Will my private well be impacted by the oil spill?
No. The oil sheen is not expected to impact domestic wells.

How will I know if my water isn't safe to drink?
Your water supplier must notify you by newspaper, mail, radio, TV, or hand-delivery if your water doesn't meet EPA or state standards or if there is a waterborne disease emergency. The notice will describe any precautions you need to take, such as boiling your water. Follow the advice of your water supplier if you ever receive such a notice.

My water tastes or smells different. What should I do?
If you have any concerns about your water, you should contact your water supplier. The oil spill is not expected to affect drinking water. If your water supply does not meet EPA or state standards your water supplier must notify you by newspaper, mail, radio, TV, or hand-delivery.

Deepwater Horizon Response Unified Command (BP Gulf oil spill response)

http://www.deepwaterhorizonresponse.com/

Hurricane Forecasts

Colorado State University meteorologists are continuing to foresee above-average activity for the 2010 Atlantic hurricane season. There are eight hurricanes predicted for the Atlantic Hurricane Season, with four major hurricanes (Category 3 or higher).

For more information on Dr. Klotzbach and Dr. Gray's forecast, visit: http://tropical.atmos.colostate.edu/forecasts/2010/april2010/apr2010.pdf

For more information on the National Hurricane Center's changes and updates to this year's hurricane forecasts, visit: http://www.nhc.noaa.gov/pdf/nhc_new_2010.pdf

Safety Announcement From FDA - High-Dose Zocor and Increased Risk of Muscle Injury

FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor* (simvastatin) and increased risk of muscle injury

[3-19-2010] Based on review of data from a large clinical trial and data from other sources, the U.S. Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class.

The clinical trial data being reviewed is from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The agency is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury (see Data Summary below).

The muscle injury, also called myopathy, is a known side effect with all statin medications. Patients with myopathy generally have muscle pain, tenderness or weakness, and an elevation of a muscle enzyme in the blood (creatine kinase). The higher the dose of statin used, the greater the risk of developing myopathy. The risk of myopathy is also increased when simvastatin, especially at the higher doses, is used with certain drugs (see Simvastatin Dose Limitations below).

The most serious form of myopathy is called rhabdomyolysis. It occurs when a protein (myoglobin) is released as muscle fibers break down. Myoglobin can damage the kidneys. Patients with rhabdomyolysis may have dark or red urine and fatigue, in addition to their muscle symptoms. Damage to the kidneys from rhabdomyolysis can be so severe that patients may develop kidney failure, which can be fatal.

Known risk factors for developing rhabdomyolysis include age (> 65 years), low thyroid hormone levels (hypothyroidism), and poor kidney function. Myopathy and rhabdomyolysis are listed as possible side effects in the simvastatin and other statin drug labels.

Healthcare professionals should:

· Understand that rhabdomyolysis is a rare adverse event reported with all statins.

· Be aware of the potential increased risk of muscle injury with the 80 mg dose of simvastatin compared to lower doses of simvastatin and possibly other statin drugs.

· Follow the recommendations in the simvastatin label regarding drugs that may increase the risk for muscle injury when used with simvastatin (see Simvastatin Dose Limitations below).

Patients should:

· Not stop taking simvastatin unless told to by their healthcare professional.

· Talk to their healthcare professional about any questions they have about the use of simvastatin.

· Call their healthcare professional if they experience any of the following: muscle pain, tenderness or weakness, urine that is dark or red-colored, or unexplained tiredness.

This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.

*Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin; and niacin as Simcor.

Additional Information for Patients

Patients currently using 80 mg simvastatin should:

· Know that rhabdomyolysis is a rare side effect reported with all statin medications.

· Not stop taking simvastatin unless told to by their healthcare professional.

· Review their medical history and current medications with their healthcare professional to determine if they should continue using simvastatin.

· Talk to their healthcare professional about any questions or concerns they have about simvastatin.

· Call their healthcare professional if they have muscle pain, tenderness or weakness, dark or red colored urine, or unexplained tiredness.

· Report any side effects with simvastatin to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.

Additional Information for Healthcare Professionals

FDA recommends that healthcare professionals should:

· Understand that rhabdomyolysis is a rare adverse event reported with all statins.

· Be aware of the potential increased risk of muscle injury with the 80 mg dose of simvastatin compared to lower doses of simvastatin and possibly other statin drugs.

· Review patients' medical history and medications to determine if simvastatin is clinically appropriate.

· Discuss with patients the benefits and risks, including the risk of myopathy and rhabdomyolysis, of simvastatin therapy.

· Be aware of potential drug-drug interactions with simvastatin.

· Report any adverse events associated with the use of simvastatin to FDA's MedWatch program using the information in the "Contact Us" box at the bottom of the page.

Data Summary

FDA's review of the SEARCH trial is part of the agency's continuing effort to evaluate the risk of muscle injury with simvastatin; this review includes evaluating data from clinical trials, observational studies, and adverse event reports, as well as data on prescription use of simvastatin.

The SEARCH trial evaluated over 6.7 years the number of major cardiovascular events (heart attack, revascularization, and cardiovascular death) in 6031 patients taking 80 mg of simvastatin compared to 6033 patients taking 20 mg of simvastatin. All patients in the study had previously had a heart attack.

Preliminary SEARCH trial results revealed that more patients in the simvastatin 80 mg group developed myopathy compared to patients in the simvastatin 20 mg group (52 [0.9%] cases compared to 1 case [0.2%]). Further, FDA's preliminary analyses of the primary data suggest that 11 (0.02%) of the patients in the simvastatin 80 mg group developed rhabdomyolysis compared to no patients in the simvastatin 20 mg group.

In 2008, the agency alerted the public about an increased risk of developing rhabdomyolysis when doses greater than 20 mg of simvastatin are given with amiodarone. The agency also included information about this drug interaction in its Summer 2008 issue of the FDA Drug Safety Newsletter¹ and in its November 2008 Patient Safety News broadcast².

In March 2010, FDA approved a labeling revision for simvastatin based on interim results from an ongoing clinical trial – the Heart Protection Study 2 (HPS2). The revised label states that patients of Chinese descent should not receive simvastatin 80 mg with cholesterol-modifying doses of niacin-containing products. Further, the revised label recommends caution when such patients are treated with simvastatin 40 mg or less in combination with cholesterol-modifying doses of niacin-containing products. The interim HPS2 results showed that the incidence of myopathy was higher in patients of Chinese descent (0.43%) compared with patients not of Chinese descent (0.03%) taking 40 mg simvastatin plus cholesterol-modifying doses (≥1 g/day) of a niacin-containing product. It is not known if the increased risk for myopathy observed in these patients applies to other patients of Asian descent.

Moreover, FDA has requested that the sponsor of simvastatin change the product labeling to instruct healthcare professionals to avoid prescribing simvastatin doses greater than 40 mg daily when patients are taking the medication diltiazem, due to an increased risk for myopathy.

A 2010 review of prescription drug use data conducted by FDA found that, despite dose limitations and drug-drug interaction precautions included in the simvastatin drug label, patients are continuing to be prescribed higher doses of simvastatin with other medications that are known to increase the risk for rhabdomyolysis (see Simvastatin Dose Limitations below).

It is important for healthcare professionals to consider the potential risks and known benefits of simvastatin compared to other cholesterol-lowering therapies when deciding to use simvastatin. Healthcare professionals should also carefully review patients' medications for potential drug-drug interactions before prescribing or dispensing simvastatin.

This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.

Ongoing Safety Review of High-dose Zocor (simvastatin) and Increased Risk of Muscle Injury http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm204882.htm

FDA Classifies Baxter's January HomeChoice Peritoneal Dialysis Cycler Field Corrective Action as a Class I Recall

Baxter is Deploying Revised Labeling, Training and Upcoming Software Revisions to Further Assist Clinicians and Patients

DEERFIELD, Ill., March 2, 2010 – Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. This action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with this issue.

About IIPV

IIPV may result in serious injury or death from conditions such as: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function and pericardial effusion. Children and non-verbal patients may be at increased risk because of their smaller size and/or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.

Patients and caregivers should watch for the potential signs of IIPV. These include: difficulty breathing; vomiting or spitting up; a child complaining of a “funny feeling” in the abdomen; a child crying during therapy without other apparent reasons; difficulties feeding; feeling full, bloated, or overfilled after treatment; abdominal pain or discomfort; expanded or tense abdomen; localized swelling around the genital area (labia, scrotum) or groin region, belly button, the tunnel tract of the peritoneal dialysis catheter or the PD catheter exit site; leakage of fluid from the PD catheter exit site; and unexpected increase in blood pressure.

If patients or caregivers notice any of these symptoms, they should stop the device, initiate manual drain, and contact their healthcare provider immediately. Additional information that will be relevant in assessing patients for IIPV includes: careful monitoring of pre- and post-treatment weight; evaluating vital signs including heart rate and blood pressure; review of the recorded ultrafiltration from the device; and development of symptoms of respiratory distress or increased effort in breathing. For patients in a clinic, hospital, or critical care setting, clinicians should consider increased monitoring. This would include evaluating oxygen saturation and evidence of abdominal tenseness.

Baxter is continuing to investigate the causes, fixes, and mitigations associated with IIPV and use of the HomeChoice device. Current mitigations under development and implementation include changes to device labeling and software, which are intended to address issues such as prescription and patient errors, including bypassing alarms. Patients will receive new Patient At-Home Guides, which contain expanded information about IIPV, the symptoms, warnings and cautions, and how to address IIPV, should it occur. Baxter has also developed and is validating a software modification to address this issue and plans to submit a 510(k) to the FDA midyear. The software update will include additional user interface messages and alarms, and change default settings and allowable ranges to reduce risk of excessive accumulation of fluid in the peritoneal cavity.

HomeChoice systems are intended for automatic control of dialysis solutions exchange in the treatment of adult and pediatric renal failure patients undergoing peritoneal dialysis. The recall notice does not require the physical return of HomeChoice units and patients may continue using them. Affected model numbers include: 5C4471, 5C4471R, 5C8310, 5C8310R, 5C4474, 5C4474R, R5C8320, R5C8320R, T5C4441, T5C4441R, T5C8300, T5C8300R, 5C4474D and 5C4474DR. It is important that clinicians rev the prescription settings for devices to help reduce prescription errors and weigh the risks and benefits of continued use of this device by their patients.

Baxter sent recall notices to clinicians and patients informing them of this action and identifying steps that are intended to reduce the harm associated with IIPV. These January 2010 letters contain more detailed information about device usage and are available at www.baxter.com. Customers or patients with questions regarding this notice may contact Baxter 24 hours a day, seven days a week at 1-800-553-6898. Any adverse reactions experienced with the use of this product, and/or quality problems, should be reported to Baxter’s Renal business at 1-888-736-2543, prompt 3, and the FDA's MedWatch Program at 1-800-FDA-1088 or www.fda.gov/MedWatch/report.htm .

“We are committed to providing peritoneal dialysis patients with the safest and most effective therapy possible,” said Bruce McGillivray, president of Baxter’s Renal business. “We stand ready to support our patients and the nephrology community as we develop and implement measures intended to reduce the occurrence of IIPV.” The company does not expect the corrections required to address the IIPV issue to be financially material.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the company’s HomeChoice systems, including expectations with respect to the cost of addressing the IIPV issue identified in this release. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: future actions of regulatory bodies and other governmental authorities, including the FDA and foreign counterparts that could substantially affect the nature or timing of the company’s actions; additional product development steps, including software development; product quality or patient safety issues; and the other factors identified in the company’s most recent filing on Form 10-K and other SEC filings, all of which are available on the company’s web site. The company does not undertake to update its forward-looking statements.

March is National Kidney Month!

http://www.nkdep.nih.gov/kidneymonth/

Kidneys filter your blood. They remove wastes and extra water. When the kidneys are diseased, they stop doing these jobs and wastes build up, damaging the body. If not treated, kidney disease can lead to kidney failure. But you can prevent kidney failure.

Early kidney disease has no symptoms. Most people don't know something is wrong until their kidneys are about to fail. The only way to tell if you have kidney disease is to get tested. Simple blood and urine tests are used to detect kidney disease.

OneTouch SureStep Test Strips (LifeScan): Recall

LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death. The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm's press release. Lot numbers are located on the outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010. It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher. Read the complete MedWatch 2010 Safety summary, including a link to the firm's press release.

Drug Safety Communication : Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp

FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer.

Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.

Patients with chronic kidney failure (includes patients on dialysis and those not on dialysis) using ESAs should:

• Know that the use of ESAs can increase the risk for stroke, heart attack, heart failure, blood clots, and death.
• Read the Medication Guide to understand the benefits and risks of using an ESA.
• Get blood tests while using ESAs. The test results may help guide the course of therapy and lower the risks of using these drugs. Patients' healthcare professionals should make them aware of how often to have blood tests.
• Talk with their healthcare professional about any questions they have about the risks and benefits of using ESAs.

Read the complete MedWatch 2010 Safety summary including links to the Drug Safety Communication and current Prescribing Information for these products, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200391.htm

RECALL: Edwards Lifesciences Aquarius Hemodialysis System

FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.

The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius.

The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.

The company received reports of clinically significant fluid imbalance.

When a certain level of fluid imbalance is detected the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. By repeatedly overriding the balance alarm without solving the issue, such as a closed clamp or kinked line, it is possible to remove too much fluid from or replace too much fluid to the patient.

In extreme cases, this could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death. Public Contact: Baxter International, Inc. is the U.S. distributor of the Aquarius.

For questions regarding the Aquarius, contact the Baxter Clinical Help Line at 1-888-736-2543.

Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes

Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump).

These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.

Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.

This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011). The firm voluntarily recalled the products after learning of the possibility of needle detachment.

FDA has been apprised of this action. No injuries have been reported to date.

Product was distributed nationwide, including Puerto Rico.

Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products.

Consumers with questions may contact the company at 305.599.7174 x249.

Helping Haiti

President Bill Clinton and President George W. Bush have established the Clinton Bush Haiti Fund for donations for the relief and support of Haiti.

The American Red Cross is working with its partners to assist those affected by this disaster. To contribute, please visit the RedCross online.

Health professionals wishing to go to Haiti, individuals, organizations, and companies wishing to make monetary contributions, or donate medical supplies or equipment, should register and indicate what resources they have at http://www.cidi.org.

For more ways to help, visit the Center for International Disaster Information (CIDI) site.

Preparing for Disasters makes Renal & Urology News' "Top 10" List

http://www.renalandurologynews.com/dialysis-chains-prepare-for-disaster/article/123903/

Dialysis Chains Prepare for Disaster

For most patients with end-stage renal disease, dialysis centers provide crucial, even lifesaving, treatment. But are dialysis facilities prepared for emergencies?