Approved by the U.S. Food and Drug Administration in July 2009, Multaq (dronedarone) is a prescription drug used to keep the heart beating normally in people with irregular heart rhythm.
Developed by Sanofi-Aventis, Multaq was designed to be a safer antiarrhythmic drug than its predecessor, amiodarone, and is most commonly used to treat disorders of the atrium — called atrial fibrillation (AFib) or atrial flutter. It is also given to reduce the need for hospitalization due to diabetes, high blood pressure, a history of stroke or being over 70 years old.
An estimated one million prescriptions for Multaq were dispensed between July 2009 and June 2011, and approximately 241,000 patients filled Multaq prescriptions at retail pharmacies in the United State, according to the FDA. The only recommended dosage of Multaq is 400 mg twice daily in adults.
The most common side effects of Multaq are diarrhea, nausea, abdominal pain, vomiting, and weakness.
Multaq contains a black-box warning — the strictest allowed by law — due to the potential increased risk of death in people with severe heart failure. In 2011, the FDA notified healthcare professionals and patients about the possibility of severe liver injury, including two cases of acute liver failure. To learn more about your eligibility for filing a claim, contact our Multaq lawyers today.
What Are the Complications Of Multaq?
Two independent studies, conducted by Sanofi-Aventis, found high death rates in certain patients, which has cast serious doubt about the drug’s future.
In 2011, the European Medicines Agency (EMA) recommended restricting the use of Multaq. The committee stated that because of the increased risk of liver, lung, and cardiovascular adverse events, dronedarone “should only be prescribed after alternative treatment options have been considered.”
Patients currently taking dronedarone should have their treatment reassessed by their physician at their next scheduled visit, according to the EMA.
Multaq has been associated with increased risks of serious side effects that should be documented and discussed with your lawyer, including:
- Acute liver failure
- Interstitial lung disease (ILD)
- Sudden cardiac death
- Blood vessel inflammation
- Systemic embolism (blood clot)
- Hospitalization for heart failure
- Pulmonary toxicity
- Shortness of breath
- Chest pain, wheezing, trouble breathing, dry cough
- Breathing problems while laying down or trying to sleep
- Severe dizziness, fainting, fast/pounding heartbeats
- Slow heart rate, feeling like you may pass out
- a new or worsening irregular heartbeat pattern
- Signs of kidney problems: little or no urinating, painful or difficult urination, blood in your urine, swelling in feet or ankles and jaundice
Numerous studies have linked Multaq (dronedarone) to heart damage.
In 2005, a clinical trial of Multaq in patients with heart damage but no atrial fibrillation was stopped because Multaq doubled the risk of death due to worsening of the existing heart failure.
Since the controversial drug’s approval, more than 100 new or worsened heart damage cases have been reported.
In 2011, the U.S. Food and Drug Administration revised the warning section of the Multaq label to note cases of worsening heart damage in some patients taking the drug. The FDA also warned of possible signals linking Multaq to a form of heart arrhythmia called torsade de pointes.
If you have any pre-existing heart conditions before taking Multaq, the use of Multaq could double your chance of death.
Numerous studies have linked Multaq (dronedarone) to acute liver damage.
In 2011, the U.S. Food and Drug Administration released a safety communication about severe liver damage associated with Multaq. The agency recommended that health care professionals advise patients “to contact a healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity while taking dronedarone.”
The FDA received reports of liver damage in patients who took Multaq pills, including two reports of patients undergoing liver transplants. Both patients who required liver transplantation were over 70 years old, had no preexisting liver problems, and ingested Multaq between 4-6 months.
Prior to a 2011 FDA safety communication alerting medical professionals and patients of Multaqs connection to the development of severe liver complications, Sanofi-Aventis had refused to disclose any information regarding a possible connection between their drug and this deadly side-effect.
Since the initial safety communication regarding Multaq caused liver damage, hundreds of reports have surfaced from Multaq users detailing instances ranging from minor quickly treated liver complications to patients requiring a liver transplant.
Public reports identified a variety of symptoms that indicate related liver damage. Users of Multaq should be aware of and remain alert for these symptoms which include:
- Not feeling well
- Yellowing of the skin or the whites of eyes
- Dark-colored urine
- Stomach pain
- Loss of appetite
If Multaq liver complications are quickly detected and treated by a medical professional, victims have a significant chance at making a full recovery.
However, reports indicate that because of the previous undisclosed nature of liver complications as a Multaq side-effect, many victims suffered prolonged damage that required extended treatment.
Those who suffered from prolonged liver complications were subjected to numerous health risks including:
- Bleeding easily
- Mental disorientation or confusion
If not quickly addressed, the above complications can have detrimental long-term effects on victims.
In the most extreme cases, a need for a liver transplant was reported due to irreparable Multaq related liver damage.
In response to these claims, Sanofi-Aventis conducted two independent studies. These studies discovered that Multaq carried a high death rate in certain patient demographics.
The existence of a manufacturer executed study indicating a severe health risk in taking Multaq has caused many medical professionals and consumers to approach any use of the drug with extreme caution.
Complications can take months to show noticeable side effects. Once they are identified, it is important that you immediately contact a medical professional to minimize any possible long-term damage.
However, liver complications are not the only previously undisclosed dangerous health complication associated with Multaq use.
If you believe that are suffering from or are currently suffering from any Multaq related health complication, contact a medical professional immediately to switch medication and begin treatment to resolve the health issue.
Less Severe Side Effects
More common and less severe side effects associated with the use of multaq include:
- Stomach pain, indigestion, nausea, vomiting, diarrhea
- Feeling weak or tired
- Skin rash, itching or redness
The U.S. Food and Drug Administration officially approved Multaq for the treatment of people who have had atrial fibrillation or atrial flutter in 2009.
There has not been a Multaq recall, but the FDA has issued warnings to doctors and patients about the potential risk of Multaq side effects, suggesting doctors should no longer prescribe the controversial drug to patients with permanent problems with abnormal heart rhythms.
Patients should stop taking the drug in cases of hepatic injury, according to the FDA. If doctors suspect a toxicity issue, they should discontinue use of the drug, and test the patient’s liver enzymes. It is not yet known how often Multaq liver damage or liver failure may occur.
The FDA also issued a safety announcement and black-box warning that data from a clinical trial demonstrated that patients with permanent atrial fibrillation who took Multaq had double the risk of serious side effects and death over patients taking a placebo.
What Are The Requirements and Criteria For Filing a Multaq Lawsuit?
The requirements for filing a lawsuit against Sanofi-Aventis, the manufacturer of Multaq, can be explained in-depth by a knowledgeable lawyer. They include:
- Severe liver failure or injury, requiring hospitalization*
- Liver transplant
- Death with liver failure — identified as a primary or secondary cause of death
- No pre-existing history of severe liver injury or hepatic dysfunction
- Concurrent use of Multaq at the time of diagnosis**
* Visitation to a physician’s office is not considered hospitalization.
**Elevated liver labs (example: ALT, AST, SGoT) alone are not sufficient for inclusion.
Seek the Services of an Experienced Multaq Attorney
Due to the recent filing nature of most Multaq dangerous drug lawsuits, drug manufacturer Sanofi-Aventis has yet to publicly issue any settlement offers to active plaintiffs.
However, as more lawsuits are filed, it will become increasingly likely that Sanofi-Aventis will begin issuing settlement offers to Multaq dangerous drug plaintiffs.
If the amount of Multaq dangerous drug lawsuits sees a significant increase, it is possible that a class action lawsuit will become active. If this does not occur, there will be a possibility for a Multaq lawsuit multidistrict litigation to be assigned.
Oftentimes, either of these occurrences increases the chances of receiving significant settlement offers. This is due to drug manufacturers desire to avoid risky public trials incurring additional financial burden and negative awareness.
Once settlement offers are issued, it is likely that they will provide compensation for the following Multaq-related damages, all of which could be calculated with the help of an experienced Multaq lawyer:
- Costs of lawsuit incurred
- Compensatory and general damages
- Punitive damages
- Special and incidental damages, including medical expenses and lost wages
- Loss of enjoyment of life, pain, and suffering, and disability
- Wrongful death damages, if the person died due to this dangerous drug
The nature of the allegations against Sanofi-Aventis — neglecting to disclose dangerous drug risks to medical professionals and consumers — could lead to a desire from the manufacturer to quickly settle cases to avoid negative headlines regarding their conduct.