FYI.....Multaq (dronedarone)- Risk of Severe Liver Injury:Reports include two cases of liver failure leading to liver transplant

[Guest guest]

Multaq (dronedarone) - Drug Safety Communication: Risk of Severe Liver Injury

AUDIENCE: Cardiology, Gastroenterology

ISSUE: FDA notified healthcare professionals and patients about cases of rare,

but severe liver injury, including two cases of acute liver failure leading to

liver transplant in patients treated with the heart medication dronedarone

(Multaq). Information about the potential risk of liver injury from dronedarone

is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of

the dronedarone labels.

BACKGROUND: Dronedarone is a drug used to treat abnormal heart rhythm in

patients who have had an abnormal heart rhythm during the past six months.

Dronedarone was approved with a Risk Evaluation and Mitigation Strategy (REMS)

with a goal of preventing its use in patients with severe heart failure or who

have recently been in the hospital for heart failure. In a study of patients

with these conditions, patients given dronedarone had a greater than two-fold

increase in risk of death.

RECOMMENDATION: Healthcare professionals were reminded to advise patients to

contact a healthcare professional immediately if they experience signs and

symptoms of hepatic injury or toxicity (anorexia, nausea, vomiting, fever,

malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching)

while taking dronedarone. Healthcare professionals should consider obtaining

periodic hepatic serum enzymes, especially during the first 6 months of

treatment. Additional information for Healthcare Professionals, for Patients and

a Data Summary is provided in the Drug Safety Communication.

Healthcare professionals and patients are encouraged to report adverse events or

side effects related to the use of this product to the FDA's MedWatch Safety

Information and Adverse Event Reporting Program:

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

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 complete MedWatch 2011 Safety summary, including a link to the Drug

Safety Communication, at:

http://go.usa.gov/rFA

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=1_14_2011_1600 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420

[Guest guest]

Multaq (dronedarone) - Drug Safety Communication: Risk of Severe Liver Injury

AUDIENCE: Cardiology, Gastroenterology

ISSUE: FDA notified healthcare professionals and patients about cases of rare,

but severe liver injury, including two cases of acute liver failure leading to

liver transplant in patients treated with the heart medication dronedarone

(Multaq). Information about the potential risk of liver injury from dronedarone

is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of

the dronedarone labels.

BACKGROUND: Dronedarone is a drug used to treat abnormal heart rhythm in

patients who have had an abnormal heart rhythm during the past six months.

Dronedarone was approved with a Risk Evaluation and Mitigation Strategy (REMS)

with a goal of preventing its use in patients with severe heart failure or who

have recently been in the hospital for heart failure. In a study of patients

with these conditions, patients given dronedarone had a greater than two-fold

increase in risk of death.

RECOMMENDATION: Healthcare professionals were reminded to advise patients to

contact a healthcare professional immediately if they experience signs and

symptoms of hepatic injury or toxicity (anorexia, nausea, vomiting, fever,

malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching)

while taking dronedarone. Healthcare professionals should consider obtaining

periodic hepatic serum enzymes, especially during the first 6 months of

treatment. Additional information for Healthcare Professionals, for Patients and

a Data Summary is provided in the Drug Safety Communication.

Healthcare professionals and patients are encouraged to report adverse events or

side effects related to the use of this product to the FDA's MedWatch Safety

Information and Adverse Event Reporting Program:

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

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 complete MedWatch 2011 Safety summary, including a link to the Drug

Safety Communication, at:

http://go.usa.gov/rFA

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=1_14_2011_1600 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420