Recall Notice: Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results

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: 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 professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated trace amounts 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 recall instructions please, reference the Recall Notice contained in the following link. Click here for more information.

KCER Team Leader to Present at Upcoming ASN Renal Week Conference in Denver

Kenneth Lempert M.D., M.S.P.H. and a team leader for the KCER Physician Placement and Assistance Response Team will be part of a panel of experts presenting on a topic entitled, “Nephrology in Natural Disasters: What to do with Acute Kidney and End Stage Renal Disease Patients During Disasters.” As part of this distinguished group, Dr. Lempert will lead a discussion focusing specifically on the Impact of Disasters on Dialysis Patients’ Health. For those interested in attending this session the date, time, and location are as follows:

Date – November 19th 2010

Time – 4:30 p.m. to 6:30 p.m. PT

Location – Denver Four Seasons 2/3

For more information click here.

Recall Notice: Excelsior Medical Identifies Potential Loss of Sterility and Leaking in 5ml Fill in 6cc Prefilled Saline Flush Syringes

On October 15, 2010, Excelsior Medical issued a recall notice that several models of its Prefilled Saline Flush Syringes had the potential to leak and/or lose sterility. The recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Please note that using syringes that have a sterility issue could result in systemic infection, which may lead to serious injury and/or death. Should you be in possession of any of these syringes, please discontinue use immediately and return them to your point of purchase. It is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

Recall Notice: CareFusion Corp. Issues Recall of Alaris PC Units (Model 8015) Due to Potential For Delay or Interruption of Therapy

On October 15, 2010, CareFusion Corporation issued a recall of its Alaris PC Units (Model 8015) manufactured between the time period of December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010. The organization identified that under certain wireless network conditions, a communication error can occur which can lead to the freezing/interruption of the PC Unit screen and a subsequent delay in therapy. Should the communication error occur during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy which could lead to serious injury or death. Any users experiencing this problem should remove the device from service and contact the CareFusion Recall Center immediately at 888.562.6018 or via email at SupportCenter@carefusion.com. Corrective action will require a hardware update to all affected units. Please also note that CareFusion does not require that the devices be returned. Click here for more information.

Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN ® and PROCRIT ®

Amgen announced September 24, 2010 that certain lots of EPOGEN(R) and PROCRIT(R) (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The recall is being conducted in cooperation with the United States Food and Drug Administration. Evaluations by Amgen and Centocor Ortho Biotech Products, L.P. found a low potential to impact patients who may have received the affected product. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity. Adverse events related to EPOGEN should be reported to 1-800-77-AMGEN. Adverse events related to PROCRIT should be reported to 1-800-547-6446. Consumers with questions regarding this recall can contact Amgen at 1-800-77-AMGEN (open 24 hours per day, 7 days per week) or Centocor Ortho Biotech Products at 1-800-547-6446 (open 24 hours per day, 7 days per week). Click here for more information.

Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients

The U.S Food and Drug Administration (FDA) is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrocholoride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight, low body surface area, and below normal serum creatinine. The revised dosing recommendations are being updated to include an upper limit on the calculated creatinine clearance using the modified Schwartz formula, which is used to calculate the pediatric dose of Valcyte. Valganciclovir is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant. Cytomegalovirus is a member of the herpes-type viruses that can cause disease in different parts of the body. Patients with weakened immune systems, such as organ transplant patients, are particularly susceptible to CMV infection and must take medications such as Valcyte to prevent the disease. Click here for more information.

BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class I Recall

Westmed, Inc. is initiating a nationwide recall of 24,834 units of BagEasy Manual Resuscitation Devices. Select lots of the BagEasy Device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation. This recall is classified by the FDA as Class I. Consumers who have units from the identified lots of BagEasy manual resuscitation devices which are being recalled should stop using them and return the product to Westmed or their distributor. To obtain a full listing of the part numbers and lo-t numbers, visit the FDA website (www.fda.gov), or contact Westmed customer service at 1-800-975-7987. Westmed voluntarily recalled these products after learning of units disconnecting at user facilities. The FDA has been apprised of this action. Westmed has become aware of potential for disconnection at the patient port retention during assembly of the BagEasy manual resuscitation device after receiving reports from three separate facilities regarding unit disconnecting during setup or use. The healthcare providers obtained another unit and continued with setup or treatment. The BagEasy manual resuscitation device was distributed to other medical device distribution companies as well as directly to hospitals and other treatment facilities. It can be identified by product labeling that contains part and lot numbers. Westmed is notifying its distributors and customers by certified mail and direct contact by sales representatives and is arranging for return of all recalled products. For more information, visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226014.htm.

Fresenius Urgent Recall for AC Power Cords

Fresenius Medical Care is initiating a recall for certain Fresenius devices that may have a defective plug, which is part of an AC power cord manufactured by Electri-Cord manufacturing company. This alert is being issued in response to a FDA Alert regarding customer reports of sparking, charring and fires of similarly designed AC power cords in non-dialysis products manufactured by other companies. Fresenius is advising all customers to assess whether their devices have the affected Electri-Cord AC power cords and inspect the cord plugs for evidence of damage (charring, discoloration of the plastic, broken or loose prongs). The potential risks from power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires, which may be exacerbated in an oxygen rich environment. Depending on the device, therapy, and environment, these failures may lead to potential serious injury or death. Fresenius Medical Care NA has not received any reports of serious patient harm related to the situation. Visit www.fmcna.com or www.fda.gov 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.

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/

Federal Government Shows Modest Progress in Disaster Planning for Children

FOR IMMEDIATE RELEASE

May 13, 2010

www.childrenanddisasters.acf.hhs.gov

Federal Government Shows Modest Progress in Disaster Planning for Children

The National Commission on Children and Disasters has delivered a report to the White House and Congressional leaders that revealed only modest progress of federal agencies in implementing recommendations designed to ensure better protections of children during major domestic disasters.

The new report (www.childrenanddisasters.acf.hhs.gov) measured the response of six federal agencies to an earlier commission report released in late 2009 that identified several shortcomings in disaster preparedness, response and recovery.

The Commission found signs of progress in the design of safer emergency sheltering environments for children. However, the report also showed federal agencies made limited progress in pediatric disaster medical care and training, disaster mental health research, and the need to encourage states and child care providers to improve their disaster preparedness plans.

“Hurricane Season is just around the corner. Kids are the most vulnerable Americans during disasters. To protect children, much more needs to be done, and it needs to be done now,” said Mark Shriver, Chairperson of the Commission.

Disasters are especially traumatic and disruptive for children. Following a catastrophic event like a hurricane, earthquake or flood, it is essential for schools and child care centers to have plans for evacuation and reunification with families. Shelters need to have age-appropriate supplies, like formula, diapers and cribs. All settings must have a plan for children with disabilities.

The Progress Report urges the Obama Administration and Congress to take bold and swift action to prepare and respond to the unique needs of children in disasters. The Commission calls for the White House to develop a National Strategy for Children and Disasters to command better integration, coordination and outcomes from federal agencies and state, Tribal, local, and non-governmental partners. Congress must provide adequate resources to support first responders, hospitals and a national disaster human services case management program to meet the recovery needs of children and families.

The National Commission on Children and Disasters is an independent, bipartisan Commission established to examine and assess the needs of children in the preparation for, response to, and recovery from all hazards. The next Commission report is due to the President and Congress in October 2010.

###

The Nashville Flood of 2010

Health and Safety Information

• Metro Public Health Department Information and Updates
• Community Health Information for re-entering your home after a flood / Spanish version
• Skin and wound care after contact with flood water / Spanish version
• Protect yourself from mold after a flood / Spanish version
• Food safety after a flood / Spanish version
• Animal care after a flood

The Metro Health Department is currently out of tetanus vaccine, but expects 2,400 doses to arrive at the Lentz Public Health Center by 12 p.m. today. Vaccines will then be available at the Lentz clinic, and doses will also be sent to the following locations:

Lentz Public Health Center (615) 340-5616
311 23rd Avenue North, Nashville, TN 37203

East Clinic (615) 862-7916
1015 East Trinity Lane, Nashville, TN 37216

Woodbine Clinic (615) 862-7940
224 Oriel Avenue, Nashville, TN 37210

• Flood waters may contain sewage and other hazardous substances – there is some risk of disease from eating or drinking anything contaminated with flood water.
• If you have any open cuts or sores that will be exposed to flood water, keep them as clean as possible by washing well with soap to control infection. If a wound develops redness, swelling, or drainage, seek immediate medical attention.
• Do not allow children to play in flood water areas, wash children's hands frequently (always before meals), and do not allow children to play with flood-water contaminated toys that have not been disinfected. You can disinfect toys using a solution of one cup of bleach in 5 gallons of water.
• If you smell the odor of natural gas in your home (similar to rotten eggs) do not turn appliances on or off, and do not use your home phone. Leave the premises immediately and call Piedmont Natural Gas from a neighbor’s home or your cell phone. Do not try to turn off your natural gas service on your own.
  Piedmont Natural Gas Safety Bulletin
• If you see a downed power line wires, assume it is live and report the emergency to 911.
• Be sure to turn off all power to flooded areas in your home containing electrical wires or appliances.

Oil Spill Notice to Dialysis and Transplant Providers

Dear Southern Louisiana Dialysis / Transplant Providers:

(Medical Directors, Nurse Managers, & Facility Administrators)

This email to provide available information and resources in regards to the Oil Spill in the Gulf of Mexico. Louisiana state officials are stressing that there is “no risk to water systems” at present. Having said that, all dialysis providers should continue to monitor your dialysis and water systems as per your routine. Please note that any disruption in normal water supply and/or maintenance issues (pressure) requires vigilance with regards to water for dialysis services. Pay extra attention to your water tests and cultures.

Be cognizant that your patients may have questions and/or concerns and your staffs should be ready to answer them accordingly. For those of you that work with peritoneal dialysis (PD) and home hemodialysis (HD) patients, please remind them to stay vigilant about their monitoring, as well. Share the air quality information listed below (e.g., odor) with your staffs and patients. The Network will continue to monitor communications from Louisiana state officials and provide updates as necessary.

Louisiana Response Information: In response to the oil leaking in the Gulf of Mexico and out of an abundance of caution, state agencies are on alert to ensure that we work to protect Louisiana’s coastline and natural resources in the event that oil reaches our shores. The state took immediate steps this week to protect our wildlife and fisheries by requesting the placement of protective barriers, called “booms” around areas of our coastline. Leaders of our affected agencies, who deal with the coast and our natural habitat, are in constant contact with the federal officials, including the United States Coast Guard. Working together, we will respond to any threat to our shores. The federal government has launched an informational website about the response to the oil leak. It is online at www.deepwaterhorizonresponse.com

Statement by Louisiana Department of Health and Hospitals / Louisiana Department of Environmental Quality Regarding Petroleum Odor in Onshore Communities:

The Louisiana Department of Health and Hospitals and the Louisiana Department of Environmental Quality are reporting that residents of coastal areas of southeast Louisiana, including New Orleans, may be detecting an odor possibly resulting from the oil spill approaching the Louisiana coast. DHH and DEQ have requested continuous air quality testing and monitoring from the EPA, and DEQ will be assisting the EPA by increasing the frequency of air sampling at its Kenner and Chalmette monitors. These samples will receive expedited turnaround by EPA labs. If it is determined that air quality issues exist, DEQ and DHH will communicate these issues immediately to local authorities or take any other action deemed appropriate to protect public health and safety.

Some people may be sensitive to any change in air quality, which could cause symptoms, such as nausea, vomiting, or headaches. If you have these symptoms, you should consider staying indoors, ventilating your home with air conditioning and avoiding strenuous outdoor activity. If these symptoms do not improve, you should then consider contacting your primary care physician or other health care provider for medical advice. If you have pre-existing medical conditions, such as asthma or other respiratory illness, you should consider communicating with your physician if you feel symptomatic.

Additional Resources:

· Environmental Protection Agency (EPA): http://www.epa.gov/safewater/index.html

· USGS public water utility information: http://water.usgs.gov/owq/FAQ.htm

· Louisiana Emergency Management Agency: http://emergency.la.gov/

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

FLOOD SAFETY: No matter what time of year it is, there is always a risk for flooding. There are many states being impacted by floods. Be sure to listen to your local news and weather for safety information specific to your area. For more information, visit the following sites:

• http://www.weather.gov/ahps/
• http://emergency.cdc.gov/disasters/floods/
• http://www.fema.gov/hazard/flood/index.shtm

Class I Recall: Baxter's HomeChoice Peritoneal Dialysis Cycler

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.

RECALL: OneTouch SureStep Test Strips (LifeScan)

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.

Disaster Preparedness Award: Call for Nominations

The Kidney Community Emergency Response Coalition (KCER) invites you to nominate an individual or organization that has provided outstanding leadership and service to the renal community in disaster preparedness and response. Please download the Disaster Preparedness Award nomination form and submit your entry today!

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

International Renal Community Coordinates Disaster Response to Earthquake in Haiti

TAMPA – A magnitude 7.0 earthquake struck outside Port-au-Prince, Haiti on January 12, 2010. Disasters can severely limit the availability of chronic dialysis treatments for individuals living with end stage renal disease (ESRD), or kidney failure. The situation in Haiti was additionally compounded by the scarcity of dialysis before the earthquake. Following the catastrophic damage, healthcare providers were limited in providing lifesaving chronic or acute dialysis treatments.

In response, the American Society of Nephrology (ASN) initiated a task force consisting of partners from the ASN Acute Kidney Injury (AKI) and Dialysis Advisory Groups, the International Society of Nephrology, the Kidney Community Emergency Response (KCER) Coalition and the Florida ESRD Network, the National Kidney Foundation, the Sociedad Latino-Americana de Nefrologia e Hipertension, dialysis providers, industry leaders, and the U.S. Departments of State and Health and Human Services.

The KCER Coalition assisted in coordinating daily teleconferences and disseminating critical information to response agencies on the ground in Haiti and the Dominican Republic. This collaboration provided a timely and effective humanitarian response to Haitian earthquake victims. Due to being pinned under collapsed buildings, individuals who survive earthquakes and are pulled from rubble may develop rhabdomyolysis, or crush syndrome. Crush syndrome can lead to acute kidney failure or death if not quickly identified and treated. According to the Centers for Disease Control & Prevention (CDC), crush syndrome occurs in 2-15% of earthquake victims. Half of the victims of crush syndrome will experience acute renal failure and half of those patients will need dialysis.

KCER will use this experience to develop best practices and outreach efforts to educate the U.S. renal community on how similar disasters could impact the provision of dialysis care. The response to Haiti and the impact of acute kidney injury will be topics of interest at this year’s KCER Summit. Held annually since the devastating impact of Hurricane Katrina, the Summit enables the renal community to stay abreast of current issues in disasters and provides a collaborative environment to advance the readiness of the renal community. This meeting is free and open to the public. The 2010 KCER Summit will be held from 1:00 to 5:00 p.m. on Tuesday, April 13 in Orlando, Florida. This meeting is being held in conjunction with the National Kidney Foundation Spring Clinical Meetings.

The Florida End Stage Renal Disease Network (Network 7) provides administrative support for the volunteer-driven KCER Coalition.

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This material was prepared by FMQAI, the End Stage Renal Disease Network for Florida (Network 7), under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy.

The Kidney Community Emergency Response (KCER) Coalition provides technical assistance to ESRD Networks, Medicare organizations, and other groups to ensure timely and efficient emergency preparedness, response, and recovery for the kidney community. KCER strives to provide resources to save lives, improve outcomes, empower patients and families, educate healthcare workers, build partnerships with stakeholders, promote awareness in the community, and support the ESRD Network Program.