Multaq (dronedarone) is a medication used to treat atrial fibrillation (or “heart flutter”). Unfortunately, it has been linked to an increased risk of liver failure, lung toxicity, heart problems, heart attack, stroke, hospitalization, and death.
Multaq (dronedarone) is a medication prescribed to people who have heart arrhythmia, which is when the heart beats either too quickly, too slowly, or irregularly. When the heart beats irregularly, it is said to be out of “normal sinus rhythm.” A person with arrhythmia often feel when their heart beats irregularly, and it may be painful. A doctor can monitor your heartbeat with a device called an echocardiogram (ECG) to take a picture of the heart, or an electrocardiogram (EKG) to monitor the heart’s electrical activity. If the doctor hears the heart beating irregularly, the patient may be diagnosed with atrial fibrillation.
In a person with atrial fibrillation, the two upper chambers of the heart beat out of sync with the two lower chambers of the heart. The problem is that sometimes blood can pool in the upper chamber, coagulate, and form a blood clot. If the heart then pumps this blood clot through the body, it may become stuck in the heart, brain, lungs, or other major internal organ, causing a stroke, heart attack, pulmonary embolism, or other deadly side effect. Blood clots that move through the body (called an “embolism”) are extremely dangerous and can cause death.
Multaq is an anti-arrhythmiac medicine, which means that it helps the heart beat in sync. It works mainly by blocking the channels through which charged particles of potassium move though muscle cells, including heart muscles. Sometimes, these charged particles produce too much electrical activity. This can lead to a heart beating too fast or an abnormal heart rhythm. Multaq inhibits the amount of potassium that can flow through the cells, thus lowering the heart rate and reducing atrial fibrillation.
European Agency Recommends Restricting Access to Multaq
On September 22, 2011, the European Medicines Agency’s Committee for Medicinal Products for human Use (CHMP) recommended that the sale and use of Multaq be restricted in Europe. Though they did not suggest an outright ban on the product, they said that it should only be used after alternative treatments had been attempted. They cited an increased risk of liver, lung, and cardiovascular adverse events.
FDA January 2011 Safety Announcement
On January 14, 2011, the FDA issued a safety alert following two reported cases of acute liver failure in patients treated with Multaq. The patients were two women approximately 70 years of age. They suffered liver injury 4.5 months and 6 months into treatment with Multaq. Both patients subsequently needed liver transplants. The FDA updated the Warnings and Precautions and Adverse Reactions section of the label to include the new information. If you have suffered a liver injury while taking this medication, you may have a Multaq lawsuit.
- The FDA is recommending that healthcare providers inform patients of the signs of liver injury or toxicity, including anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant abdominal pain, jaundice, dark urine, or itching
- Give patients a liver enzyme test within the first 6 months of Multaq treatment
- Discontinue Multaq if liver injury is suspected and monitor liver enzymes for signs of injury
- Patients with a history of liver problems should not use Multaq
FDA July 2011 Safety Announcement
On July 21, 2011, the FDA issued its second safety warning, after reviewing data from a clinical trial that was researching whether Multaq was effective at treating people with permanent atrial fibrillation (Multaq is only approved for non-permanent atrial fibrillation). The study was halted prematurely when researchers found that the drug doubled a person’s risk of death, and doubled the incidence of stroke and hospitalization for heart failure compared to patients taking a placebo.
The PALLAS study (Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy), conducted by the drug-maker Sanofi-Aventis, was a randomized, double-blind study compared the use of Multaq versus a placebo. The study enrolled more than 3,000 people 65 years or older, who had permanent atrial fibrillation for at least six months. In July 2011, the researchers reviewed the preliminary evidence, and found that the patients treated with Multaq had significantly higher rates of death, heart attack, stroke, systemic embolism, and heart failure. Many people who have suffered these side effects are now filing a Multaq lawsuit. After the researchers reviewed these findings, the PALLAS study was immediately stopped.
The FDA recommended that people with permanent atrial fibrillation not be prescribed Multaq, and it said that it would continue to review the use of Multaq for people with non-permanent atrial fibrillation.
FDA December 2011 Safety Announcement
On December 19, 2011 the FDA announced that it had completed its safety review of Multaq. Though the PALLAS study showed that Multaq should not be used in patients with permanent atrial fibrillation, the ATHENA study showed that it might still be beneficial for people with non-permanent atrial fibrillation. So far, the FDA has decided that people with non-permanent atrial fibrillation should still be prescribed this medication.
The FDA made the following updated recommendations:
- Multaq is only indicated for use in people with a history of non-permanent atrial fibrillation
- Heath-care providers should not prescribe Multaq to patients with permanent atrial fibrillation
- Health-care providers should monitor patients’ heart rhythm with an electrocardiogram (ECG) every three months. If the patient has developed permanent atrial fibrillation, Multaq should be stopped.
- Health-care providers should prescribe Multaq patients with anti-blood clot medicine to reduce the risk of thrombotic events such as heart attack or stroke
Serious Side Effects
If you have experienced any of the following side-effects, or any other side effect after taking Multaq, you may have a Multaq lawsuit and you should contact a lawyer at the Schmidt Firm LLP. Life-threatening side effects include:
- Lung disease
- Blood vessel inflammation
- Pulmonary Toxicity
- Hospitalization for heart failure
- Acute liver failure requiring hospitalization and liver transplant
- New or worsening heart problems
- Heart attack
- Heart failure
- Systemic embolism (blood clot)
Symptoms of Liver injury:
- Loss of appetite, nausea, vomiting
- Fever, feeling unwell
- Unusual fatigue
- Yellowing of the skin or white of the eyes (jaundice)
- Unusually dark urine
- Right upper abdominal pain or discomfort
Other Side Effects:
- Stomach pain