Drug maker Sanofi makes the medication Multaq, which has the generic name dronedarone. It was first approved by the U.S. Food and Drug Administration (FDA) in 2009 for the treatment of cardiac arrhythmia, or irregular heartbeat, also known as atrial fibrillation. Studies have shown that Multaq can reduce hospitalization for patients with arrhythmias, but not fatalities. The label indicates this distinction.
Since the drug first came on the market the FDA has updated its labeling information to include more serious warnings for some of the risks of using Multaq. Patients with certain types of heart failure or arrhythmia should not take the drug because it can actually cause death. In Europe the use of the drug has been restricted over these and other issues. If you have been harmed by Multaq or lost a loved one because of it, you may have a case against Sanofi-Aventis.
Multaq is the generic drug dronedarone that was approved for use in the U.S. in 2009. Developed, manufactured, and marketed by French company Sanofi, it was designed to be an alternative to an earlier drug called amiodarone. Dronedarone belongs to the class of drugs called class III antiarrhythmic drugs. It is used to treat atrial fibrillation and atrial flutter, two types of arrhythmias. It is not indicated for reducing death due to these conditions, only for reducing hospitalizations.
The information for Multaq on its package insert includes a black box warning that certain patients may actually die from using the drug. This was updated in 2011, just two years after the medication came on the market. Since then the European Medicines Agency has recommended that Multaq not be used as a first line treatment for arrhythmias because of the risk of death and other serious potential complications.
Uses for Multaq
The only current indication for Multaq, approved by the FDA, is for reducing hospitalizations for patients with atrial fibrillation or atrial flutter. These patients must have a regular heart rhythm to be prescribed Multaq, but they have had these conditions in the past. The drug is contraindicated for patients whose arrhythmias are not controlled. Multaq helps patients’ hearts beat normally and regularly and in doing so reduces the need to be hospitalized.
It is important to control conditions like atrial fibrillation and atrial flutter because they can lead to serious complications otherwise. Atrial fibrillation, for instance, increases the risk of having a stroke, heart failure, and the formation of blood clots. Atrial flutter is a less serious arrhythmia, but can deteriorate and turn into an atrial fibrillation.
The most common side effects associated with Multaq are nausea, abdominal pain, diarrhea, vomiting, and asthenia, or weakness. Patients using the drug may also experience a rash or redness. These side effects are usually not serious unless they worsen.
Serious side effects may indicate a dangerous or life-threatening complication and should be reported immediately. These include shortness of breath and wheezing, difficulty breathing or swallowing, swelling in the face or throat, tightness in the chest, coughing that is either dry or frothy, quick weight gain, bleeding, jaundice, flu symptoms, vision loss, dark urine, light colored stool, pain in the upper right abdomen, and confusion.
Black Box Warning
The FDA included a black box warning with Multaq because of the possibility of death for certain patients using it. The warning states that patients with serious heart failure, Class IV or Class II or III accompanied by recent hospitalization or episode, are not supposed to use Multaq. Recent studies showed that these patients are at a greater risk of death by heart disease when using the drug. Heart failure severe enough to warrant discontinuation of Multaq is characterized by shortness of breath, even when resting.
Multaq is also contraindicated because of the risk of death for patients with an arrhythmia like atrial fibrillation that cannot be controlled or converted back to a regular rhythm. These patients, with permanent atrial fibrillation, may be at a greater risk for hospitalization, for a stroke or for death when using Multaq.
In addition to the less severe side effects and the black box warnings, Multaq also has the potential to trigger liver damage and failure. Patients should be tested for liver failure before being prescribed the drug and then evaluated later for liver enzyme levels. Signs of liver failure include nausea, vomiting, loss of appetite, a fever and other flu-like symptoms, yellowing of the whites of the eyes or skin, dark urine, and pain in the upper right area of the stomach. These should be reported immediately.
Use Restricted in Europe
In Europe the European Medicines Agency has taken the risks of Multaq seriously enough to warn the public and to restrict its use. The agency stated that it found the risk of liver damage and damage to the lungs seen in studies was serious enough that doctors should consider other treatments for patients before prescribing Multaq. The FDA has also issued warnings about the risks, but has stopped short of restricting its use beyond the indications listed for the drug.
There are no current lawsuits against Sanofi over Multaq, but that may soon change. As more studies indicate the very serious risks of using the drug, more patients are at risk of being harmed by it. Not all of the warnings about death, stroke, liver damage and other risks were clear when the medication first came on the market. This means that Sanofi may be held liable for the damage the drug has caused to patients who were not aware of the risks before using it.
If you think you have a case to make against Sanofi because of the damage Multaq caused you or because you believe it led to the death of a loved one, there are steps you can take. A lawyer can help you decide if your case is strong enough to proceed and can represent you as you move forward to seek the compensation you feel you are owed for not being warned about the risks of Multaq.
- http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/What-is-Atrial-Fibrillation-AFib-or-AF_UCM_423748_Article.jsp - .V7Rob_krJpg