What is Multaq?
Multaq (dronedarone) is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter). Multaq can reduce the risk of being hospitalized for these heart problems.
Multaq is manufactured by the drug company Sanofi-Aventis, based in Paris, France.
In January 2011 the FDA issued a drug safety alert for Multaq concerning severe liver injury, such as liver failure requiring liver transplantation, associated with Multaq use.
In July 2011 the FDA issued a second and different drug safety alert for Multaq. This one had to do with its review of new data from a medical study which indicated there was a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving Multaq compared to patients taking a placebo.
In December 2011 the FDA said Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF).
In September 2012 the FDA approved label changes for Multaq, including one about certain types of lung disease such as pneumonitis and pulmonary fibrosis being serious side effects of Multaq use.
Lastly, cases of renal impairment and kidney damage in patients using Multaq have been reported.
Our law firm represents people in personal injury and wrongful death cases that involve certain adverse medical events which might have been caused by Multaq, such as:
- Liver transplant
- Acute liver or hepatic failure
- Liver damage
- Liver disease
- Drug-induced hepatitis
- Renal impairment
- Kidney damage
- Cardiovascular (CV) Death
- Heart Failure (HF) Hospitalization
- Stroke (CVA)
- Lung / Pulmonary disease
- Pulmonary fibrosis
We continue to monitor this emerging drug-safety issue involving Multaq and will be updating this Multaq Information page accordingly.
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Multaq Liver Injury Side Effects: Updates From FDA And Health Canada In March 2011
The FDA approved a change to the Multaq package insert, or label, and Health Canada posted on their web site two new documents with Multaq safety information from Sanofi-Aventis: (1) a Public Communication for patients; and, (2) a so-called "Dear Doctor" letter for health care professionals.
Heart Drug Multaq Linked To Severe Liver Injury, Including Acute Liver Failure With Liver Transplant
There have been several case reports of liver injury and liver failure in patients treated with Multaq, including including two cases of acute liver failure requiring liver transplantation, according to "Dear Doctor" letter from Sanofi-Aventis.
Multaq: FDA Approved In July 2009 For Two Heart Rhythm Disorders, Atrial Fibrillation And Atrial Flutter
Multaq drug safety warnings from FDA include 2009 label "black-box" warning about heart failure patients and 2011 label change to warn about drug-induced liver injury including liver failure.
Multaq Class Actions: An Individual Lawsuit Is Better
Multaq litigation information from Multaq lawyer about legal compensation claims for liver failure, liver transplant, and other adverse reactions associated with Multaq.
Multaq and Legal Compensation
Drug injury law firm explains why individual Multaq lawsuits are better than Multaq class actions for liver failure and liver transplant. Free Multaq case evaluation by experienced lawyer will help you determine whether you have a possible lawsuit.
Drug Injury Watch: Multaq News And Commentary
Multaq Associated Lung Disease And Pulmonary Toxicity Pointed Out By New Safety Warnings In September 2012 Revised Label
Heart Drug Multaq Can Cause Pulmonary Fibrosis And Pneumonitis; Symptoms Are Inflammation Of The Lungs, Including Scarring And Thickening
SUMMARY: In September 2012 the FDA approved more label changes for the safety-challenged heart drug Multaq (dronedarone), including one about certain types of interstitial lung disease such as pneumonitis and pulmonary fibrosis being serious side effects of Multaq use.
[Read this article in full at original source]
Earlier Multaq articles by attorney Tom Lamb on the Drug Injury Watch blog:
Sanofi Heart Drug Multaq Found To Be Dangerous For Patients With Permanent Atrial Fibrillation
European Medicines Agency (EMA) Recommends Multaq Use Should Be Restricted For Safety Reasons
Multaq: August 2011 Update: Another Liver Failure Case Report Article In Medical Journal
Multaq Cardiovascular Deaths Overshadow Earlier Liver Injury Concerns For Drug Regulators
Sanofi Heart Medication Multaq Has Constantly Been On FDA's Radar During 2010 And 2011
Multaq Update: European Safety Review Expanded To Cardiovascular Side Effects Risk In July 2011
Sanofi-Aventis "Dear Doctor" Letter Will Warn Heart Drug Multaq Associated With Liver Failure
All content by attorney Tom Lamb