Important Medical Alerts

August 2011
Sensipar: Safety Labeling Changes Approved by FDA Center for Drug Evaluation Research. View the FDA warings and precautions.
August 27, 2011
H & P Industries and FDA notified health professionals and the public of a recall of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel due to inadequate microbial testing. See the Safety Alert including lot numbers.
August 3, 2011
The FDA notified healthcare professionals of a Class I recall of the Arrow NextStep Antegrade Chronic Hemodialysis Catheters, due to reports of breakage and/or separation of the stylet. See the Safety Alert with a link to the Recall Notice for a listing of affected product and lot numbers.
July 11, 2011
Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL). Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012). View the FDA Tamiflu safety alert.
June 24, 2011
FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease. View the FDA Safety Communication
March 18, 2011 (Update May 3, 2011)
H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination. View the FDA Safety Information.
February 5, 2011 (Update April 27, 2011)
American Regent Injectable Products: Recall - Visible Particulates in Products View the FDA Safety Alert.
February 1, 2011
B. Braun Announces Class I recall of Outlook 400ES Safety Infusion System. View the FDA safety information.
January 6, 2011
Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination. View the FDA announcement.
November 5, 2010
WalkMed Infusion Issues Nationwide Recall of Triton Infusion Pump. View the press release.
October 29, 2010
B. Braun Voluntarily Recalls Seven Lots of Heparin Manufactured in 2008. View Press Release Details.
September 24, 2010
Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN(R) and PROCRIT(R) (Epoetin alfa). View Press Release Details HERE.
June 28, 2010
Fresenius Medical Care has issued an urgent device recall for medical devices having AC power cords manufactured by Electri-Cord Manufacturing Company.
May 24, 2010
CMS has announced that Medicare beneficiaries will soon receive important information in the mail about the immediate benefits they may see from the enactment of the Affordable Care Act. Further information is in this brochure.
February 26, 2010
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.
February 16, 2010
The FDA has issued a Drug Safety Communication regarding Procrit, Epogen, and Aranesp. The FDA is requiring all drugs called Erythropoiesis-Stimulating Agents (ESAs) to be prescribed and used under a risk management program.
January 29, 2010
The FDA and Edwards Lifesciences have 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.
January 25, 2010
Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes
January 11, 2010
Rapamune (sirolimus): Wyeth Revises Drug Monitoring Recommendations—Switching between assays for the same patient can produce differing results that may be clinically significant .
October 3, 2009
Philips Issues Worldwide Recall of Select Heartstart Fr2+ Automated External Defibrillators.
October 1, 2009
FDA alerts healthcare providers of a Change in the Heparin USP monograph.
September 25, 2009
American Regent has warned healthcare professionals about risks and precautionary measures concerning Desferrum (iron dextran injection). The boxed warning has been modified.
September 3, 2009
FDA has added important safety information to the Warnings and Adverse Reactions sections of myfortic prescribing information.
August 21, 2009
Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes.
August 13, 2009
FDA has notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars.
These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.
May 9, 2008
Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement. Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used. There have been many reports of deaths associated with allergic or hypotensive symptoms after heparin administration (see FDA link at http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm). We ask that health professionals and facilities please review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all of the recalled heparin products have been removed and are no longer available for patient use. In addition, FDA would like to inform health professionals about other types of medical devices that contain, or are coated with, heparin. To read this update, and to learn how to report these problems to FDA, please go to: http://www.fda.gov/cdrh/safety/heparin-healthcare-update.html. Please report to FDA adverse reactions associated with these devices, as well as any reactions associated with heparin or heparin flush solutions. If you have questions or would like more information about this request, please contact the Division of Drug Information at 301-796-3400.
March 12, 2008
Amgen and FDA Announce Changes to Erythropoiesis Stimulating Agents Boxed Warnings
Information now describes the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs (Aranesp and EPOGEN/PROCRIT).
July 20, 2007
Update to March 12, 2007, posting: Medicare to Modify its Claims Monitoring Policy for Use of ESAs for Anemia Treatment in Dialysis
The Centers for Medicare & Medicaid Services (CMS) has announced that it is strengthening its erythropoiesis stimulating agent (ESA) Monitoring Policy (EMP) for claims for ESAs used to treat anemia in Medicare beneficiaries who are receiving dialysis treatment for end stage renal disease (ESRD).
March 12, 2007
FDA Revises Recommendations Regarding ESAs
The U.S. Food and Drug Administration (FDA) has revised the labeling information for Erythropoiesis Stimulating Agents (ESAs) and issued revised recommendations for dosing and monitoring patients using ESAs. Full details can be found on the FDA Web site. The Renal Physicians Association (RPA), the National Kidney Foundation (NKF), the American Association of Kidney Patients (AAKP), and the Centers for Medicare and Medicaid Services (CMS) have responded publicly to the FDA's recommendations. Patients who are concerned about their use of ESAs should consult their own health care team.
December 22, 2005
Pandemic Flu Information
Network 11 would like to keep you and your facility informed regarding a potential Pandemic Flu. All states have been required by the Centers for Medicare and Medicaid Services (CMS) to develop state-wide Pandemic Flu Plans. The Network 11 Pandemic Flu page contains links to each state's Pandemic Flu Plan and a variety of other resources.

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Important Medical Alerts