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Multaq side effects leads to lawsuits

According to the U.S. Food & Drug Administration, Multaq (dronedarone) has been associated with liver damage and severe liver failure. The agency announced in 2011 an addition to the black box label for Multaq to warn patients of risk of severe complications and death. Doctors use Multaq to treat patients who have had an abnormal heart rhythm during the past six months. The FDA does not recommend Multaq for patients with recent severe heart failure or those referred to specialized heart failure clinics for the condition. Atrial fibrillation results from abnormal electrical activity in the upper chambers of the heart, leading to an irregular heart rhythm. According to the National Heart, Lung and Blood Institute, an estimated 2 million people in the U.S. suffer from atrial fibrillation, or a rapid and irregular heart beating.

You or a loved one may have suffered liver damage, severe liver failure or other adverse effects while taking Multaq. Contact Greg Jones Law as you may be entitled to compensation for medical bills, lost wages and pain and suffering.

Multaq Side Effects:

  • Nausea
  • Weight loss
  • Diarrhea
  • Abdominal pain
  • Vomiting
  • Weakness
  • Shortness of breath
  • New or worsening heart failure
  • Pain in the upper right quadrant
  • Lowered blood calcium and magnesium when taken with potassium-depleting diuretics
  • Irregular heartbeats
  • Fatigue
  • Itching
  • Liver problems
  • Jaundice
  • Dark urine

Multaq Adverse Reactions

The FDA cleared Multaq (dronedarone) for sale in 2009. Since its approval, Sanofi-Aventis has received multiple complaints of liver function test abnormalities and hepatocellular liver injury in patients. In two cases, two women of about 70-years of age required a full liver transplant. Since its introduction, about 200,000 patients worldwide received treatment with Multaq. Approximately 147,000 United States patients received and filled their Multaq prescriptions.

Among liver damage, Multaq has other risks including heart failure, irregular heartbeats, serious interactions with other drugs and impaired kidney function. According to a large drug study called Andromeda Study, patients with severe heart failure or heart-failure hospitalization were 2.5 times as likely to die if taking Multaq. According to clinical trials, study participants had their medication discontinued due to adverse reactions before the end of the studies.

According to the Independent Institute for Safe Medicine Practices, its quarterly update on drug safety included reports that Multaq (dronedarone) had more associated cases of slow heartbeat, a rapid heartbeat in the heart’s main chamber, and an uncontrolled arrhythmia in the atria than any other drug monitored by the institute.

The FDA warned healthcare professionals to monitor serum liver enzymes during the first six months of Multaq treatment. The agency also warns that patients should contact their healthcare professional immediately if they experience signs of liver injury, including weight loss, nausea, vomiting, fever, fatigue, jaundice, dark urine and itching.

Dronedarone and amiodarone health risks

Sanofi developed Multaq (dronedarone) as a derivative of amiodarone. Amiodarone is an antiarrhythmic agent used to treat irregular heartbeats. Amiodarone has an increased risk of pulmonary toxicity, which could potentially be deadly. As it is associated with fatal toxicities, the FDA recommends amiodarone for treating life-threatening, recurrent ventricular arrhythmias that have not responded to other treatment. According to the FDA, pulmonary toxicity is fatal approximately 10 percent of the time, although rates of 17 percent occurred in patients with ventricular arrhythmias who took doses of 400 mg a day. While the chemical structures of dronedarone and amiodarone are similar, they have significant differences. Dronedarone is usable with warfarin without adverse reactions, but warfarin dosages require a decrease when used with amiodarone.

FDA Issues a Warning Letter to Sanofi

The FDA issued a warning letter to Sanofi earlier this year and made the letter public. The FDA accuses Sanofi of failing to give the agency serious and unexpected adverse drug reactions within 15 calendar days of receiving them, as required. The agency further claims that Sanofi failed to turn over all post-marketing studies on some drugs and adverse event evaluations. The FDA reported 13 instances of where Sanofi received notification of adverse events while taking Multaq but did not report those concerns to the agency within the 15-day limit. Severe liver damage was among three of those reported events. Several cases went unreported for two years after Sanofi received notification.

Multaq is a high-profit drug, according to Bloomberg reports. Sanofi may reach revenue of $1.1 billion by 2013 according to Bloomberg’s analysts. Sales of Multaq in the U.S. reached $115 in the first nine months of 2010.

Multaq received approval in 2009, yet the dangerous drug has had a high number of adverse effects, 387 recorded, and fatalities, 24 Multaq-related deaths reported. If you or a loved one suffered a liver injury, liver failure, or required a liver transplant while using Multaq (dronedarone) we urge you to call Greg Jones law today to protect your legal rights. Our firm can help you get the compensation you deserve.

Call Greg Jones Law at 855-566-3752 or contact us online.

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