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With more than a million people residing in the two states, residents of Kentucky and Tennessee are exposed to a multitude of potential accidents. Freeways, highways, and city streets pose a daily threat to residents. As the traffic grows so do the number of motor vehicle accidents.
The following is a list of practice areas in which the attorneys at Hughes and Coleman are experienced and proven. Click on an area to discover a wealth of information on each topic. If you have been affected by any of the following, contact Hughes and Coleman Injury Lawyers today for a free consultation.
Multaq® is the brand name for the drug dronedarone, which is manufactured by French pharmaceutical Sanofi S.A., formerly known as Sanofi-Aventis. Multaq® is used to prevent arrhythmias that require the person to be hospitalized because in the past 6 months they have suffered atrial flutter or atrial fibrillation.
The FDA issued a Drug Safety Communication warning to the public and healthcare professionals on January 14, 2011, that Multaq had caused a number of hepatocellular liver injury and hepatic failure cases. In two of these incidents, the patients required liver transplants after using the Multaq® for just four-and-a-half months and six months. Prior to taking Multaq® their livers were healthy. Upon explanting these livers there was evidence of extensive hepatocellular necrosis.
Multaq® Side Effects
In July 2009, the FDA approved the sale of Multaq® in 400 mg oral tablets and manufactured by Sanofi. According to FDA records, from the approval date for Multaq® until October 2010, there have been 492,000 Multaq® prescriptions filled by 147,000 people.
The Drug Safety Communication lists the following symptom from the use of Multaq®:
|• Fatigue||• Yellow eyes or skin (jaundice)||• Light-colored stools||• Itching||• Vomiting||• Nausea|
|• Fever||• Dark urine||• Loss of appetite||• Anorexia||• Right upper quadrant pain|
The FDA recommends Multaq® users who have experience one or more of these symptoms immediately report them to their doctor, who will conduct liver tests. The FDA has updated the “Warnings and Precautions” section of the Multaq® drug label to reflect these concerns.
Multaq® and the FDA
Two weeks after the Drug Safety Communication, the FDA sent a warning letter to Sanofi, because it the drug-maker failed to comply with FDA postmarketing regulations, specifically, “inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events;” failure to submit serious and unexpected adverse drug experience (ADE) reports within 15 calendar days to the FDA;” and “failure to include all postmarketing studies in the Annual Report to FDA.”
The FDA now requires that the Multaq® drug label contain a black box warning, which is the most serious advisory available. The FDA advises physicians to not prescribe Multaq® if a patient has been diagnosed with New York Heart Association (NYHA) Class IV heart failure, or who have been diagnosed with NYHA Class II and III heart failure after a recent hospitalization.
The black box Multaq® warning is the result of a study that tested 627 people with symptoms of heart failure. The researchers gave 310 of them Multaq and 317 a placebo. After 63 days, they discovered that 8.1% of the Multaq® had died compared to 3.8% in the placebo group. It was discovered that Multaq® users required hospitalization at a much higher rate.
Our Drug Injury Lawyers Can Help
If you or someone you know has been affected by a drug injury, Hughes & Coleman wants to help. We help people nationwide get the compensation they deserve. Call 800-800-5200 or fill out a free consultation form today.