In keeping with all of the news surrounding a halted Multaq study, Sanofi-Aventis, the makers of the drug, has formally alerted doctors that one of the Multaq clinical studies for the drug had to be stopped because patients in the study’s Multaq group died twice as often as the patients taking the placebos.
“Healthcare professionals are advised to monitor patients regularly (at least every six months) in order to ensure that they remain within the approved indication and do not progress to permanent atrial fibrillation or new or worsening heart failure,” the letter to the doctors said.
The clinical trial was stopped on July 7. The study consisted of monitoring some of the patients who were over 65 and suffering from permanent atrial fibrillation as well as at least one more cardiovascular disease risk fact. When the study was halted, it caused the European Medicines Agency to lengthen a safety review that it began back in January. That safety review was conducted once it was found that Multaq could be linked to reports of liver failure.
The FDA chose to review Multaq’s potential link to heart complications after it was told that the trial was stopped. The FDA has stated that anyone currently taking Multaq should contact his or her doctor to see if they really need to. The FDA also sent a reminder to doctors not to prescribe the drug to anyone that has permanent atrial fibrillation. While Multaq was supposed to be a safer alternative to taking amiodarone for patients suffering from temporary atrial fibrillation, the drug still is associated with potentially life-threatening conditions.
If you or a loved one has suffer from Multaq liver failure, contact attorney Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.