FDA MedWatch – INRatio and INRatio2 PT/INR Monitor System by Alere

KCER Release Date: July 13, 2016 Audience: ESRD Networks and Facilities, Nephrologists, Dialysis Staff http://www.kcercoalition.com/en/alerts-recalls/ INRatio and INRatio2 PT/INR Monitor System by Alere: Recall – Potentially Inaccurate INR Results ISSUE: Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System. BACKGROUND: In December 2014, Alere initiated a voluntary …

Read more

FDA MedWatch – Canagliflozin and Dapagliflozin

Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication – Strengthened Kidney Warnings AUDIENCE: Endocrinology, Internal Medicine, Nephrology, Pharmacy ISSUE: FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).  Based on recent reports, we have …

Read more

FDA MedWatch: Over the Counter Antacid Products

FDA MED WATCH Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication – Serious Bleeding Risk AUDIENCE: Consumer ISSUE: The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products …

Read more

FDA MedWatch-Loperamide (Imodium)

FDA MedWatch Loperamide (Imodium): Drug Safety Communication – Serious Heart Problems With High Doses From Abuse and Misuse AUDIENCE: Pharmacy, Cardiology, Internal Medicine, Pain Management, Consumer ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, …

Read more

FDA MedWatch- Canagliflozin (Invokana, Invokamet)

KCER Release Date: May 18, 2016 Audience: ESRD Networks and Facilities www.kcercoalition.com/resources/alerts-and-recall-notifications/ Canagliflozin (Invokana, Invokamet): Drug Safety Communication – Clinical Trial Results Find Increased Risk of Leg and Foot Amputations ISSUE: FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly …

Read more

FDA MedWatch: Fluoroquinolone Drugs

KCER Release Date: May 13, 2016 Audience: ESRD Networks and Facilities www.kcercoalition.com/resources/alerts-and-recall-notifications/ Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with …

Read more

FDA MedWatch: Olanzapine

FDA MedWatch KCER Release Date: May 11, 2016                                    Audience: ESRD Networks and Facilities www.kcercoalition.com/resources/alerts-and-recall-notifications/ Olanzapine: Drug Safety Communication – FDA Warns About Rare but Serious Skin Reactions Including Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax ISSUE: FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress …

Read more

FDA MedWatch: Class I Recall – Defective Conductivity Sensors

KCER Release Date: May 4, 2016 Audience: ESRD Networks and Facilities www.kcercoalition.com/resources/alerts-and-recall-notifications/ Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall – Defective Conductivity Sensors AUDIENCE: Risk Manager, Nephrology ISSUE: B. Braun Medical Inc. is recalling the Dialog+ Hemodialysis System due to cracks in conductivity sensors that may allow air to enter into the …

Read more

FDA MedWatch: Brintellix (Vortioxetine)

KCER Release Date: May 4, 2016 Audience: ESRD Networks and Facilities www.kcercoalition.com/resources/alerts-and-recall-notifications/ Brintellix (vortioxetine): Drug Safety Communication – Brand Name Change to Trintellix, to Avoid Confusion with Antiplatelet Drug Brilinta (ticagrelor) ISSUE:  FDA has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from …

Read more

FDA MedWatch: G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers by Dexcom

FDA MedWatch KCER Release Date: April 12, 2016 Audience: ESRD Networks and Facilities www.kcercoalition.com/resources/alerts-and-recall-notifications/ G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers by Dexcom: Class I Recall – Audible Alarm Failure ISSUE: Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when …

Read more

FDA MedWatch: Metformin

KCER Release Date: April 8, 2016 Audience: ESRD Networks and Facilities www.kcercoalition.com/resources/alerts-and-recall-notifications/ Metformin-containing Drugs: Drug Safety Communication – Revised Warnings for Certain Patients With Reduced Kidney Function AUDIENCE: Pharmacy, Nephrology, Internal Medicine, Patient ISSUE: FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with …

Read more

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 …

Read more