FDA MedWatch: Diabetes Medications Containing Saxagliptin and Alogliptin

KCER Release Date: April 5, 2016

Audience: ESRD Networks and Facilities

www.kcercoalition.com/resources/alerts-and-recall-notifications/

Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication – Risk of Heart Failure

Including:

  • Onglyza (saxagliptin)
  • Kombiglyze XR (saxagliptin and metformin extended release)
  • Nesina (alogliptin)
  • Kazano (alogliptin and metformin)
  • Oseni (alogliptin and pioglitazone)

ISSUE: An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, FDA is adding new warnings to the drug labels about this safety issue.

This Communication is an update to the 02/11/2014 FDA Drug Safety Communication.

BACKGROUND: Saxagliptin and alogliptin are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, which are used with diet and exercise to lower blood sugar in adults with type 2 diabetes.

FDA evaluated two large clinical trials conducted in patients with heart disease. These clinical trials were also discussed at the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting in April 2015. Each trial showed that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo (see Data Summary in the FDA Drug Safety Communication for additional information). In the saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo. This is the same as 35 out of every 1,000 patients compared to 28 out of every 1,000 patients. Risk factors included a history of heart failure or kidney impairment. In the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group. This is the same as 39 out of every 1,000 patients compared to 33 out of every 1,000 patients.

RECOMMENDATION: Health care professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.

Patients taking these medicines should contact their health care professionals right away if they develop signs and symptoms of heart failure such as:

  • Unusual shortness of breath during daily activities
  • Trouble breathing when lying down
  • Tiredness, weakness, or fatigue
  • Weight gain with swelling in the ankles, feet, legs, or stomach

Patients should not stop taking their medicine without first talking to their health care professionals.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494252.htm

FDA Safety Communication

KCER Release Date: March 30, 2016 Audience: ESRD Networks and Facilities

www.kcercoalition.com/resources/alerts-and-recall-notifications/

OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc.: FDA Safety Communication – Do Not Use

ISSUE: The FDA is recommending consumers, businesses, schools, and healthcare providers stop using OxySure Portable Emergency Oxygen System, Model 615 because of several device malfunctions, including ineffective oxygen delivery, and chemical reactions in the canisters that could cause them to explode.

Due to adverse event reports to the FDA and the company’s failure to address the device’s safety issues noted during inspections and in the FDA’s warning letter, the FDA is concerned that patients and other users of OxySure Portable Emergency Oxygen System, Model 615 are at risk for serious adverse health consequences, such as burns and death.

The FDA will continue to work with OxySure Therapeutics, Inc. to bring these devices into regulatory compliance and will keep the public informed if significant new information becomes available.

BACKGROUND: OxySure Portable Emergency Oxygen System is intended to produce oxygen for emergency use.

Since June 2013, OxySure Therapeutics, Inc. has distributed at least 1,000 units of the OxySure Portable Emergency Oxygen System, Model 615 nationwide. These devices may be purchased without a prescription and can be used in businesses, schools, and other public places (e.g., gyms, shopping malls, and airports). See the FDA Safety Communication for additional information.

RECOMMENDATION: The FDA recommends customers stop using the OxySure Portable Emergency Oxygen System, Model 615 and immediately transition to an alternative FDA-cleared emergency oxygen device.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report

Download form or call 1.800.332.1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1.800.FDA.0178

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm492970.htm

 

FDA Safety Alert

Baxter Issues Voluntary National Recall of One Lot of 0.9% Sodium Chloride Solution for Irrigation Due to Presence of Particulate Matter

Consumers

Baxter International Inc.

1-800-422-9837 onebaxter@baxter.com

Baxter International Inc. of Deerfield, Illinois, is voluntarily recalling one lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle solution to the hospital/user level. This product is being recalled due to a customer complaint prior to use for the presence of particulate matter, identified as an insect.

Sodium Chloride Irrigation solution with foreign material contamination potentially could result in a series of complications dependent in which anatomic location the irrigation is used, which could include inflammatory reaction, foreign body reaction, and infection which could be life-threatening.

To date, Baxter has not received any reports of adverse events related to this recall. 0.9% Sodium Chloride for Irrigation USP – 500 mL is an isotonic solution intended for irrigation. This solution can be used to rinse debris and residue from wounds and as a single use for rinsing/irrigation during surgical procedures. It may also be used to flush or rinse medical equipment such as catheters. The recall affects the following lot:

Product Code Product Description Lot Number Expiration Date NDC
2F7123 0.9 % Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle G120162 11/30/2018 0338-0048-03

The lot being recalled was distributed to customers and distributors in the United States between November 12, 2015 and January 11, 2016.

Baxter is notifying its distributors and customers by letter that they should not use product from the recalled lot. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.

Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Baxter

Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

 

Content from:          http://www.fda.gov/Safety/Recalls/ucm486687.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

CDC Request

Undetermined Cause of Cardiac Arrest During Hemodialysis, 2015

The Connecticut Department of Public Health (CT DPH) has received reports of six patients that experienced sudden cardiovascular collapse leading to cardiac arrest during routine outpatient hemodialysis; three of the six expired.  Four cases occurred in one clinic on 12/18, 12/19, and 1/12.  There have been two other cases, one on 12/18 in a separate clinic, and one on 12/30, in a third clinic.  These events occurred 30 to 135 minutes after the initiation of the hemodialysis treatment and not immediately following administration of a medication.

The three cases who expired had findings suggestive of an anaphylactic reaction (airway edema noted clinically and/or during autopsy and elevated serum tryptase level).

While such events can occur among hemodialysis patients during their treatment, this number of these events clustered in time appears to be unusual; therefore, CT DPH and the Centers for Disease Control and Prevention (CDC) are collaborating on an investigation.  Possible etiologies under consideration include contamination of medications or medical devices.

Requested Actions

CDC is requesting notification about similar cases that may have occurred in other dialysis centers from November 2015 to present.

Specifically requesting notification of the following: (1) a patient who had cardiovascular collapse and/or cardiac arrest during hemodialysis with signs/symptoms of anaphylaxis; (2) a patient who had severe anaphylactic reaction during hemodialysis without cardiac arrest; or (3) two or more patients in the same facility who had cardiac arrest without anaphylaxis that occurred during hemodialysis and within 24 hours of each other; from November 2015 to the present.

Please forward this notification to haioutbreak@cdc.gov.

Flu Season Begins: Severe Influenza Illness Reported

CDC HEALTH ADVISORY

Distributed via the CDC Health Alert Network
February 1, 2016, 0850 EST (8:50 AM EST)
CDCHAN-00387

CDC urges rapid antiviral treatment of very ill and high risk suspect influenza patients without waiting for testing

Summary

Influenza activity is increasing across the country and CDC has received reports of severe influenza illness. Clinicians are reminded to treat suspected influenza in high-risk outpatients, those with progressive disease, and all hospitalized patients with antiviral medications as soon as possible, regardless of negative rapid influenza diagnostic test (RIDT) results and without waiting for RT-PCR testing results. Early antiviral treatment works best, but treatment may offer benefit when started up to 4-5 days after symptom onset in hospitalized patients. Early antiviral treatment can reduce influenza morbidity and mortality.

Since October 2015, CDC has detected co-circulation of influenza A(H3N2), A(H1N1)pdm09, and influenza B viruses. However, H1N1pdm09 viruses have predominated in recent weeks. CDC has received recent reports of severe respiratory illness among young- to middle-aged adults with H1N1pdm09 virus infection, some of whom required intensive care unit (ICU) admission; fatalities have been reported. Some of these patients reportedly tested negative for influenza by RIDT; their influenza diagnosis was made later with molecular assays. Most of these patients were reportedly unvaccinated. H1N1pdm09 virus infection in the past has caused severe illness in some children and young- and middle-aged adults. Clinicians should continue efforts to vaccinate patients this season for as long as influenza viruses are circulating, and promptly start antiviral treatment of severely ill and high-risk patients if influenza is suspected or confirmed.

Recommendations

  1. Clinicians should encourage all patients who have not yet received an influenza vaccine this season to be vaccinated against influenza. This recommendation is for patients 6 months of age and older. There are several influenza vaccine options for the 2015-2016 influenza season (see http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6430a3.htm ), and all available vaccine formulations this season contain A(H3N2), A(H1N1)pdm09, and B virus strains. CDC does not recommend one influenza vaccine formulation over another.
  1. Clinicians should encourage all persons with influenza-like illness who are at high risk for influenza complications (see list below) to seek care promptly to determine if treatment with influenza antiviral medications is warranted.
  1. Decisions about starting antiviral treatment should not wait for laboratory confirmation of influenza. Clinicians using RIDTs to inform treatment decisions should use caution in interpreting negative RIDT results. These tests, defined here as rapid antigen detection tests using immunoassays or immunofluorescence assays, have a high potential for false negative results. Antiviral treatment should not be withheld from patients with suspected influenza, even if they test negative by RIDT; initiation of empiric antiviral therapy, if warranted, should not be delayed.
  1. CDC guidelines for influenza antiviral use during 2015-16 season are the same as during prior seasons (see http://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm ).
  1. When indicated, antiviral treatment should be started as soon as possible after illness onset, ideally within 48 hours of symptom onset. Clinical benefit is greatest when antiviral treatment is administered early. However, antiviral treatment might still be beneficial in patients with severe, complicated, or progressive illness, and in hospitalized patients and in some outpatients when started after 48 hours of illness onset, as indicated by clinical and observational studies.
  1. Treatment with an appropriate neuraminidase inhibitor antiviral drugs (oral oseltamivir, inhaled zanamivir, or intravenous peramivir) is recommended as early as possible for any patient with confirmed or suspected influenza who
    • is hospitalized;
    • has severe, complicated, or progressive illness; or
    • is at higher risk for influenza complications. This list includes:

– children aged younger than 2 years;

– adults aged 65 years and older;

– persons with chronic pulmonary (including asthma), cardiovascular (except hypertension alone), renal, hepatic, hematological (including sickle cell disease), metabolic disorders (including diabetes mellitus), or neurologic and neurodevelopment conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability [mental retardation], moderate to severe developmental delay, muscular dystrophy, or spinal cord injury);

– persons with immunosuppression, including that caused by medications or by HIV infection;

– women who are pregnant or postpartum (within 2 weeks after delivery);

– persons aged younger than 19 years who are receiving long-term aspirin therapy;

– American Indians/Alaska Natives;

– persons who are morbidly obese (i.e., body-mass index is equal to or greater than 40); and

– residents of nursing homes and other chronic-care facilities.

  1. Antiviral treatment can also be considered for suspected or confirmed influenza in previously healthy, symptomatic outpatients not at high risk on the basis of clinical judgment, especially if treatment can be initiated within 48 hours of illness onset.
  1. Clinical judgment, on the basis of the patient’s disease severity and progression, age, underlying medical conditions, likelihood of influenza, and time since onset of symptoms, is important when making antiviral treatment decisions for outpatients.
  1. While influenza vaccination is the best way to prevent influenza, a history of influenza vaccination does not rule out influenza virus infection in an ill patient with clinical signs and symptoms compatible with influenza. Vaccination status should not impede the initiation of prompt antiviral treatment.

Background

Seasonal influenza contributes to substantial morbidity and mortality each year in the United States. In the most recent influenza season—the 2014-2015 season—CDC estimates that there were approximately 19 million influenza-associated medical visits and 970,000 influenza-associated hospitalizations [1]. The spectrum of illness observed thus far during the 2015-2016 season has ranged from mild to severe and is consistent with that of other influenza seasons. Although influenza activity nationally is low compared to this time last season, it is increasing; and some localized areas of the United States are already experiencing high activity. Further increases are expected in the coming weeks. Typically, influenza seasons begin with increases in influenza-like-illness and the percent of respiratory specimens testing positive for influenza in clinical laboratories. Those indicators are rising at this time. Increases in severity indicators tend to lag behind. At this time, national surveillance systems that track severity are not elevated, but CDC will continue to watch for indications of increased severity from influenza virus infection this season.

Laboratory data so far show that most circulating flu viruses are still like the viruses recommended for the 2015-2016 influenza vaccines. CDC will continue to monitor circulating influenza viruses for changes that might impact vaccine effectiveness and publish these data weekly in FluView (http:/www.cdc.gov/flu/weekly/summary.htm). CDC also is conducting epidemiologic field studies to determine vaccine effectiveness this season.

For more information:

  1. Summary of Weekly U.S. Influenza Surveillance Report (http:/www.cdc.gov/flu/weekly/summary.htm)
  2. People at High Risk of Developing Flu–Related Complications (http://www.cdc.gov/flu/about/disease/high_risk.htm)
  3. Clinical Signs and Symptoms of Influenza (http://www.cdc.gov/flu/professionals/acip/clinical.htm)
  4. ACIP Recommendations for the Prevention and Control of Influenza with Vaccines, United States, 2015-16: Summary for Clinicians (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6430a3.htm)
  5. Influenza Antiviral Medications: Summary for Clinicians (http://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm)
  6. Guidance for Clinicians on the Use of Rapid Influenza Diagnostic Tests (http://www.cdc.gov/flu/professionals/diagnosis/clinician_guidance_ridt.htm)
  7. Prevention Strategies for Seasonal Influenza in Healthcare Settings (http://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm)
  8. Guidance for the Prevention and Control of Influenza in the Peri- and Postpartum Settings (http://www.cdc.gov/flu/professionals/infectioncontrol/peri-post-settings.htm)
  9. Interim Guidance for Influenza Outbreak Management in Long-Term Care Facilities (http://www.cdc.gov/flu/professionals/infectioncontrol/ltc-facility-guidance.htm)
  10. Patient Education: Influenza Brochures, Fact Sheets, and Posters (http://www.cdc.gov/flu/freeresources/index.htm)

Endnotes

  1. Centers for Disease Control and Prevention. Estimated influenza illnesses and hospitalizations averted by influenza vaccination – United States, 2014-15 influenza season. (http://www.cdc.gov/flu/about/disease/2014-15.htm)

The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.

CDC HEALTH ADVISORY

CDC Urging Dialysis Providers and Facilities to Assess and Improve Infection Control Practices to Stop Hepatitis C Virus Transmission in Patients Undergoing Hemodialysis

Distributed via the CDC Health Alert Network
January 27, 2016, 1030 EST (10:30 AM EST)
CDCHAN-00386

Summary The Centers for Disease Control and Prevention (CDC) has received an increased number of reports of newly acquired hepatitis C virus (HCV) infection among patients undergoing hemodialysis. Infection control lapses in dialysis care could expose patients to HCV. Any case of new HCV infection in a patient undergoing hemodialysis should prompt immediate action. CDC is urging dialysis providers and facilities to:

1) Assess current infection control practices and environmental cleaning and disinfection practices within the facility to ensure adherence to infection control standards; 2) Address any gaps identified by the assessments; 3) Screen patients for HCV, following CDC guidelines, to detect infections, determine treatment potential, and halt secondary transmission; and 4) Promptly report all acute HCV infections to the state or local health department.

Background CDC has received an increased number of reports of acute HCV infection among patients undergoing hemodialysis. Between 2014 and 2015, CDC has been contacted about 36 cases of acute HCV infection in 19 different hemodialysis clinics in eight states. While investigations are ongoing, so far, HCV transmission between patients has been demonstrated at nine of those clinics, based on epidemiologic and viral sequencing evidence. Lapses in infection control (e.g., injection safety, environmental disinfection, and hand hygiene) were commonly identified at these facilities. Although the exact means of transmission could not be discerned, these lapses all could potentially contribute to HCV transmission. The increase in acute HCV infections might be due, in part, to improved screening and awareness of the potential for HCV infection in the hemodialysis setting. Regardless, this increase underscores the widespread potential for patients to acquire serious infections during dialysis care.

Dialysis facilities should actively assess and continuously improve their infection control, environmental cleaning and disinfection, and HCV screening practices, whether or not they are aware of infections in their clinic. Any case of new HCV infection in a patient undergoing hemodialysis is likely to be a healthcare-associated infection and should be reported to public health authorities in a timely manner. A recent publication describes a dialysis facility where an outbreak of HCV continued for five years before being detected, highlighting the importance of HCV screening to identify these infections early and prevent further transmission.1  HCV transmission can be prevented when proper infection prevention and environmental disinfection practices are consistently followed.

Recommendations In response to the increased identification of HCV transmission in dialysis clinics, CDC recommends the following actions be followed:

Dialysis providers

  • Evaluate infection control practices in each facility and ensure adherence to infection control standards.
  • If gaps are identified, promptly address any issues to protect patients’ health and safety (http://www.cdc.gov/dialysis/).
  • Ensure staff are aware of and trained to implement infection control guidelines (http://www.cdc.gov/dialysis/guidelines/index.html) for hemodialysis settings.3,4 Facilities should provide regular (e.g., annual) training (http://www.cdc.gov/dialysis/clinician/index.html) of staff to ensure adherence to infection control recommendations.3,4
  • Follow CDC recommendations for HCV screening of hemodialysis patients and management of patients who test positive:
    • CDC recommends that chronic hemodialysis patients be screened for HCV antibody12,13 (anti-HCV) (http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm) upon admission to the dialysis clinic and every six months thereafter if susceptible to HCV infection.5
    • For those patients with a positive anti-HCV test result, the test should be followed with a Nucleic Acid Test (NAT) for HCV RNA.6 Follow CDC recommendations for interpretation of test results and further actions.7 Ensure patients identified to have HCV infection are aware of the diagnosis and are referred to appropriate care and evaluation. Persons with chronic HCV infection, including those with end-stage renal disease, may benefit from treatment.
  • Immediately report any case of new HCV infection among patients undergoing hemodialysis to the state or local health department.5,8
    • New HCV infection can present as a change in anti-HCV status from negative to positive, in the absence of signs or symptoms.
    • Communicate test results to the patient and arrange for clinical evaluation for possible treatment of HCV infection.
    • Determine the HCV infection status of all other patients receiving care in the facility.
  • Be transparent. Inform patients if HCV transmission is suspected to have occurred within the facility, and explain steps being taken to address the problem.

Health departments

  • Investigate any acute HCV infection in a hemodialysis patient for a possible healthcare-associated etiology.9

Patients

  • If you do not know if you have or might have hepatitis C, ask your healthcare provider.
  • Ask your healthcare providers questions about your dialysis care, such as:
    • Do you follow CDC recommendations?
    • Do I need to be tested for hepatitis C virus?
    • What can be done to prevent me from getting an infection during my dialysis treatment?
  • Review educational resources for patients (http://www.cdc.gov/dialysis/patient/index.html) on dialysis safety and hepatitis C10,11(http://www.cdc.gov/hepatitis/hcv/cfaq.htm) provided by CDC and other partners.

Additional Resources

The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

IPRO Wins Four Regional Dialysis Quality Improvement Contracts

 (Lake Success, NY) December 9, 2015 – IPRO has won four regional End-Stage Renal Disease (ESRD) Network quality improvement contracts to support dialysis patients, families and providers in 13  states across the U.S.

Last week the U.S. Centers for Medicare & Medicaid Services (CMS), announced it was awarding five-year contracts totaling $110 million in Medicare funding to seven entities nationwide.

IPRO will be responsible for Network 1 (Maine, New Hampshire, Vermont, Rhode Island, Connecticut and Massachusetts); Network 2 (New York); Network 6 (North Carolina, South Carolina and Georgia); and Network 9 (Ohio, Indiana and Kentucky). IPRO was the incumbent ESRD Network contractor in New England and New York but is a first-time awardee in Networks 6 and 9.

“We’re pleased and grateful that CMS has renewed our contracts in New York and New England while extending our Network leadership responsibilities to two other regions of the U.S.,” says IPRO Chief Executive Officer Theodore O. Will.

”With the assistance of our large volunteer community, our organization will be responsible for supporting 117,000 patients, 1684 facilities and 52 transplant facilities, across the four regions,” says IPRO ESRD Network CEO Susan Caponi, RN, MBA. “That translates to one-quarter of our nation’s ESRD patient population.”

For more information please see full  Press Release