Multaq® and FDA
Prescribed to regulate the heartbeat of patients with cardiac arrhythmia, Multaq® is a 400 mg pill taken twice a day every day. The drug is intended to prevent hospitalization for patients with serious heart problems.
The drug has recently come under fire by researchers around the world because of reports of serious side effects in users. The drug, like many others, has temporary side effects, including skin irritation, hair loss, nausea, fatigue, wheezing and chest tightness.
The more serious side effects that have been reported include bradycardia (slow heartbeat), impaired liver function and kidney failure.
Multaq® FDA Black Box Warning
The US Food and Drug Administration (FDA) is tasked with approving medications prior to their release on the market. Multaq® underwent FDA review in 2008, when the drug was given priority review. Many were hopeful for a safer alternative to amiodarone in the treatment of patients with cardiac arrhythmias.
While Multaq® did receive FDA approval from the Cardiovascular and Renal Drugs Advisory Committee, it did not take long for complaints to begin coming in from patients suffering from adverse effects.
When the FDA first approved Multaq®, it required that the package label carry a Black Box warning to alert patients of the risk of death in patients with a history of heart failure. A boxed warning is the strongest warning the FDA gives.
Multaq® New Drug Application Information
When Sanofi-aventis, the manufacturer of Multaq®, applied for FDA approval, it completed a New Drug Application (NDA). Multaq®'s NDA was given priority review status, which is often assigned to applications for new medications that provide a safe alternative to riskier medications.
Patients with atrial fibrillation, atrial flutter or another cardiac arrhythmia had been prescribed amiodarone, a related antiarrhythmic associated with liver damage.
If you or a loved one has taken Multaq® and experienced permanent damage from its negative side effects, contact a qualified Multaq® attorney to review your case. You might be eligible to recover compensation for your injury.
