The popular anti-arrhythmic drug Multaq (dronedarone) is linked to severe, life-threatening side effects. The medication is often prescribed to elderly people with atrial fibrillation, a type of irregular heartbeat.
Unfortunately, Multaq side effects include heart injury, heart failure, heart attack, stroke, liver injury, liver failure, acute liver disease, lung disease, pulmonary toxicity, and death. Many people who were injured are now seeking legal guidance, justice, and compensation.
UPDATE
September 12, 2012 — The FDA and Sanofi-Aventis are currently in the process of updating the label on Multaq to warn about lung disease and Pulmonary Toxicity. Click here to read more.
Drug Overview
Multaq (dronedarone) is a drug that is often prescribed for the treatment for atrial fibrillation, or irregular heartbeat. This is when the heart beats too fast, too slow, or out of sync. Irregular heartbeat is also known as “heart flutter,” which occurs when the two upper chambers of the heart beat out of sync with the two lower chambers.
People who have an irregular heartbeat usually feel it occasionally. Sometimes, it is very painful and frightening. When these people visit a doctor, the doctor may perform an imaging scan of the heart called an “echocardiogram” (ECG). He or she may also perform a test of the electrical signals in your heart, called an “electrocardiogram” (EKG). These tests can help a doctor diagnose irregular heart rate, or atrial fibrillation.
If you are diagnosed with atrial fibrillation, you may be prescribed Multaq. Though this medication can help many people with heart problems, it also has significant side effects. If you have experienced any of these side effects, you may have a Multaq lawsuit and you should contact a lawyer, because you may be entitled to compensation for injury caused by this drug.
Multaq helps prevent atrial fibrillation by affecting the electrical impulses that go through a person’s heart. In a normal heart, the muscle cells transmit electrical impulses through potassium channels. Multaq works by inhibiting the transfer of potassium through these channels, thus slowing down a person’s heartbeat, and preventing irregular racing heart-rate.
For people with non-permanent atrial fibrillation, this can be very beneficial. The danger of having this heart disorder is that, sometimes, blood pools in the upper chamber. This blood can form blood clots. If the blood clots break loose, the heart could accidentally pump them through the body. If the blood clots get stuck in your heart, brain, lungs, or other major internal organ, they can cause death or other serious, debilitating injury. Unfortunately for people with permanent atrial fibrillation, Multaq actually increases the chance of suffering serious cardiovascular injury, liver injury, and death. That is why the FDA recommends that only people with a certain type of atrial fibrillation use Multaq — a type called “paroxysmal” or “persistent atrial fibrillation.”
European Agency Restricts Access to Multaq
On September 22, 2011, the European Medicines Agency’s Committee for Medicinal Products for human Use (CHMP) decided that they would advice physicians in Europe only prescribe Multaq as an alternative medicine after other options had already been exhausted. Their reasons for recommending against the use of the drug was the high risk of Multaq side effects, including liver and heart failure.
FDA Multaq Safety Warning for Liver Failure
On January 14, 2011, the FDA issued a new warning to consumers after receiving reports that two users of Multaq had suffered acute liver failure. Both people were females, approximately 70 years old, who had a history of atrial fibrillation and had been taking Multaq for 4.5 months and 6 months. Both women required a liver transplant. The Warnings and Precautions and Adverse Reactions section of the safety labeling information has been updated to include the new information about liver failure, liver damage, and liver toxicity. If you have suffered liver damage or any other liver injury, you may have a Multaq lawsuit.
The FDA recommended that patients learn the signs of liver problems, which include sudden weight-loss, nausea, vomiting, fever, tiredness, abdominal pain in the upper-right part of the stomach area, jaundice (yellowing of the eyes), unusually dark urine, and itching.
The FDA also recommended that physicians give new users of Multaq regular liver enzyme tests, at least once every three months. If liver injury is suspected, the patient should immediately stop using Multaq. Patients with a history of liver problems should not use the medication.
FDA Multaq Safety Warning after PALLAS Study
On July 21, 2011, the FDA issued the second Multaq safety warning following alarming results from a preliminary research study that was testing the use of Multaq in patients who had permanent atrial fibrillation. Sanofi-Aventis, the maker of Multaq, conducted the PALLAS study (Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy). The study followed more than 3,000 people over the age of 65 who had permanent atrial fibrillation. Half the group used a placebo, and half the group used Multaq. When the researchers reviewed preliminary data, they found that the Multaq-users had twice the risk of death, twice the risk of stroke or hospitalization for heart problems. The study was ended immediately and the FDA issued a safety warning.
If you have used Multaq and experienced a stroke, hospitalization, or know someone who died as a result of using this medication, you should contact a lawyer for a Multaq lawsuit.
FDA Multaq Safety Warning for Heart Attack, Stroke, Death
On December 19, 2011 the FDA issued a third safety warning to consumers and users of the anti-arrhythmic drug Multaq. After reviewing the results of the PALLAS study, the FDA found that Multaq was still beneficial for people who had non-permanent atrial fibrillation.
The FDA made the following recommendations:
- Multaq should only be used in people who have a 6-month history of non-permanent atrial fibrillation
- If a patient develops permanent atrial fibrillation, the use of Multaq should be ended immediately
- If a patient is using Multaq, the physician should monitor the patient every 3 months with an electrocardiogram (EKG) to find out of the patient is developing permanent atrial fibrillation.
- If a patient develops permanent atrial fibrillation at any time, the use of Multaq should be stopped immediately
- Physicians should prescribe Multaq in conjunction with an anti-clotting drug to reduce the chance that the patient will develop a blood clot or embolism that could cause heart attack, stroke, or death
Multaq 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 Clark Firm LLP. Serious Multaq side effects include:
- Stroke
- Hospitalization for heart failure
- Pulmonary Toxicity
- Lung disease
- Blood vessel inflammation, scarring, narrowing
- Acute liver failure requiring hospitalization and liver transplant
- New or worsening heart problems
- Heart attack
- Heart failure
- Systemic embolism (blood clot)
- Death
Symptoms of Liver injury:
- Loss of appetite, nausea, vomiting
- Fever, feeling unwell
- Unusual fatigue
- Itching
- Yellowing of the skin or white of the eyes (jaundice)
- Unusually dark urine
- Right upper abdominal pain or discomfort
Other Side Effects:
- Diarrhea
- Nausea
- Stomach pain
- Fatigue
- Vomiting
- Weakness
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