Heart Drug Multaq Shown to Double the Risk of Serious Heart Problems in Some Patients
More and more dangerous drugs are being shown to cause more serious health conditions than the ones they are designed to treat. In some cases, the drug has even been shown to adversely affect the part of the body it is designed to treat.
A case in point is the popular drug Multaq. The brand name version of dronedarone was made by Sanofi-Aventis to treat atrial fibrillation (a fast or irregular heartbeat) or atrial flutter (a fast but regular heartbeat), but preliminary results from a clinical trial have shown that it doubles the risk of stroke, heart failure and death from cardiac causes in patients who had permanent atrial fibrillation or who were at risk for other cardiovascular events.
The Facts: Multaq and Dronedarone
- Multaq received FDA approval in 2009 as a treatment to maintain normal heart rhythms in patients with atrial fibrillation or atrial flutter and other accompanying conditions. The FDA authorized marketing the drug as a way to reduce hospitalizations, not deaths.
- Upon approval, the FDA issued a “Black Box” warning – its strongest possible warning – that patients with a history of heart failure should not take the drug as it increased the risk of serious health conditions, including death.
- In early 2011, the FDA issued an alert for healthcare workers about cases of severe liver damage associated with the use of dronedarone (Multaq). The drug’s label was changed to say that treatment should stop if liver injury is suspected.
Multaq and Increased Risk of Heart Failure
There have been several reports linking the use of Multaq to an increased risk of heart failure or other cardiac events.
The FDA warned of a possible connection between Multaq and congestive heart failure in early 2010, then followed up later that year about a link between the drug and a potentially fatal form of heart arrhythmia. Another warning followed that year about a potentially adverse reaction when Multaq is combined with the anti-clotting drug Warfarin.
In July 2011, the FDA issued a warning about Multaq after a clinical trial of patients with permanent atrial fibrillation had to be stopped because it showed that patients who took Multaq were twice as likely to suffer a stroke, heart failure or death than those patients who took only a placebo.
The results of the PALLAS study were preliminary, but regulators advised doctors not to prescribe Multaq to patients with permanent atrial fibrillation or severe heart failure.
Multaq Risks and Warnings
The FDA has advised patients taking Multaq to talk to their doctors about whether they should continue taking the drug and to report any adverse side effects right away. Regulators say that stopping the drug without a doctor’s guidance could be dangerous.
Those who are taking Multaq should report any of the following symptoms, as they could be a sign of more serious health conditions:
- Shortness of breath or wheezing
- Any problems breathing
- Irregular heart beat
- Slow or fast heart beat
- Swelling in ankles or feet
- Chest pain
- Rapid weight gain
- Dizziness or fainting
- Fatigue
- Fever or flu-like symptoms
- Nausea or vomiting
- Unusual bruising or bleeding
Patients should tell their doctors if they have a history of heart disease or heart problems, severe liver disease, or kidney disease. Pregnant and breastfeeding women should not take Multaq.
NC Multaq and Dronedarone Lawyers
Hundreds of thousands of patients have been prescribed Multaq since it was approved. If you or a loved one received Multaq to treat your atrial fibrillation or other health condition, and you believe you suffered serious health complications as a result, you may be entitled to compensation under the law. Call the Law Offices of James Scott Farrin at 1-866-844-4262 for a free case evaluation. Find out if one of our North Carolina Multaq lawyers can help you get the justice you may deserve!
