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Nexterone FDA Alerts

The FDA Alert(s) below may be specifically about Nexterone or relate to a group or class of drugs which include Nexterone (amiodarone).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for amiodarone

Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up

Aug 31, 2020

Audience: Consumer, Health Professional, Pharmacy

August 28, 2020 -- Mylan N.V. today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials.

These batches are being recalled due to the potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. The individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection, USP or Tranexamic Acid Injection, USP. Both of these medications are administered in a hospital setting only by trained healthcare professionals. To date, Mylan has not received any reports of adverse events related to this recall.

Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP are used to treat different conditions. If Tranexamic acid is administered to a patient in place of Amiodarone or vice versa, it could present a risk to patient safety. If Amiodarone HCl Injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower than expected heart rate, which could have immediate life-threatening effects on cardiac function. If treatment with Amiodarone HCl Injection, when needed, is delayed this could result in continued irregular heartbeat and potential life-threatening effects on cardiac function. If Tranexamic Acid Injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with Tranexamic Acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events.

Amiodarone HCl Injection, USP is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients’ refractory to other therapy. Tranexamic acid injection is indicated in patients with hemophilia for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

These batches were distributed nationwide in the USA to wholesalers and hospital/clinical pharmacies between April 2020 and July 2020. The recalled batch information is as follows:

NDC # Material Description Strength Carton Size Lot No. Expiry
67457-153-09 Amiodarone HCl Injection, USP 450 mg/9 mL 10 x 9 mL single-dose vials 191207
191221
191223
200120
Nov. 2021
Nov. 2021
Nov. 2021
Dec. 2021
67457-197-10 Tranexamic Acid Injection, USP 1000 mg/10 mL 10 x 10 mL single-dose vials

Mylan is notifying its wholesalers and hospital/clinic pharmacies by letter and is arranging for return of recalled products to Stericycle. Wholesalers and hospital/clinic pharmacies that have product which is being recalled should stop use/further distribution or dispensing. Wholesalers and hospital/clinic pharmacies that are in possession of recalled product should contact Stericycle at 1-888-410-7505 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.

Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

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.

  • Complete and submit the report Online
  • Regular Mail or Fax: 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

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

About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

Source: FDA

Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter

Nov 15, 2017

Audience: Pharmacy, Cardiology, Risk Manager

ISSUE: Baxter International announced it is voluntarily recalling one lot of Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 6/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of particulate matter. The particulate matter may have entered the solution during the manufacturing process. The recalled lot number is NC109925.

The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which Nexterone is packaged.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization.

BACKGROUND: Nexterone is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform health care professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail user level. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, between 7 a.m. and 6 p.m. Central Time.

Customers with questions regarding this recall can contact Baxter Corporate Product Surveillance at 800-437-5176, Monday through Friday, between 8 a.m. and 5 p.m. Central Time. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

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:

[11/15/2017 - Press Release - Baxter]

Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone

Mar 24, 2015

Audience: Cardiology, Infectious Disease, Gastroenterology, Pharmacy

[Posted 03/24/2015]

 

ISSUE: FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. FDA is adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. FDA is recommending that health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone.

FDA review of submitted postmarketing adverse event reports found that patients can develop a serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi combined with another direct-acting antiviral is taken together with amiodarone. The reports included the death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker to regulate their heart rhythms. The other patients recovered after discontinuing either the hepatitis C drugs or amiodarone, or both (see Data Summary). The cause of these events could not be determined. FDA will continue to monitor Harvoni and Sovaldi for risks of serious symptomatic bradycardia and further investigate the reason why the use of amiodarone with these hepatitis C drugs led to the heart-related events.

BACKGROUND: For a Data Summary and additional recommendations for health professionals and patients, see the FDA Drug Safety Communication.

RECOMMENDATION: Health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone. However, in cases where alternative treatment options are unavailable, FDA recommends heart monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.

Due to the long half-life of amiodarone, patients discontinuing amiodarone just prior to starting Harvoni, or Sovaldi in combination with another direct-acting antiviral, should also undergo similar cardiac monitoring as outlined above.

Patients taking either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone should seek medical attention right away if they experience signs or symptoms of symptomatic bradycardia such as:

  • Near-fainting or fainting
  • Dizziness or light-headedness
  • Malaise
  • Weakness
  • Excessive tiredness
  • Shortness of breath
  • Chest pains
  • Confusion or memory problems

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:

[03/24/2015 - Drug Safety Communication - FDA]

Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems

May 6, 2011

Audience: Critical Care Medicine, Emergency Medicine, Cardiology, Risk Manager

Reports Received on Adenosine and Amiodarone Products

 

[UPDATED 05/06/2011] FDA recommends that, to reduce the potential risks to patients, healthcare professionals and risk managers stock crash carts, ambulances, and emergency rooms with adenosine and amiodarone supplied in vials or pre-filled plastic syringes, if possible. The use of needleless pre-filled glass syringes in emergency situations should be avoided.

Refer to the May 2011 FDA Drug Safety Communication, featuring photos, a list of affected adenosine and amiodarone products, and IV access systems known to be incompatible with adenosine and amiodarone pre-filled glass syringes.

 

[Posted 11/17/2010]
 

ISSUE: FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems. Most of the reports have been related to pre-filled needleless glass syringes that contain adenosine, often when attempting to connect to some pin activated needleless IV access systems. Adenosine is a cardiac drug that is administered when a patient has a rapid or irregular heart rhythm in an attempt to return their heart rhythm to normal. Adenosine must be injected rapidly into the blood stream in emergency situations and this failure could delay treatment.

In some cases where an attempt is made to connect to pin activated needleless IV access systems, the syringe may cause the pin to break thus clogging the syringe, or damaging the IV tubing and/or the needleless connector and requiring reestablishment of a new intravenous access. These failures can cause a delay in administration of the medication, which could potentially result in serious harm to patients.

BACKGROUND: Adenosine pre-filled glass syringes are marketed by Teva, Sagent, Baxter, and Wockhardt. FDA has also received reports of problems related to certain pre-filled needleless glass syringes containing the cardiac drug amiodarone. See the FDA letter for a list of affected adenosine and amiodarone products. 

RECOMMENDATION: Healthcare professionals, risk managers, and staff who purchase, stock, or administer emergency crash cart medications, operating room medications, emergency drug boxes, or types of emergency drug caches should be alerted to this incompatibility problem and potential for damage or blockage of the IV line and delay in administering the medication. Healthcare organizations currently using glass prefilled syringes should consider stocking adenosine supplied in vials or pre-filled plastic syringes as a back up measure.

FDA has expanded the scope of its review to include all currently marketed pre-filled needleless glass syringes intended for use with needleless intravenous access systems, where delay in administration could potentially result in a life threatening event. FDA is working with manufacturers to correct the problem and identify additional mitigation strategies.

Healthcare professionals and healthcare organization managers are encouraged to report adverse events or problems experienced with the use of needleless pre-filled glass syringes to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. FDA is interested in receiving information on the type, manufacturer and NDC numbers of the prefilled syringes and type and manufacturer of needleless IV access devices. FDA is especially interested in any description of the nature of the syringe failure, any adverse patient outcomes, and any mitigation strategies that have been identified or implemented by users of these products. 

 
[05/06/2011 - Drug Safety Communication - FDA] 
[11/17/2010 - Letter to Stakeholders - FDA]

Simvastatin Used With Amiodarone

Aug 8, 2008

Audience: Cardiologic healthcare professionals, pharmacists, other healthcare professionals

[Posted 08/08/2008] FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

[August 08, 2008 - Drug Information Page - FDA]
[August 08, 2008 - Information for Healthcare Professionals - FDA]

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