Sanofi-Aventis, determined to keep Multaq on the market and prove that it is safe and effective to use, has announced that researchers are getting ready to conduct another clinical trial to see if Multaq can be used with Ranexa.
This new trial is going to be referred to as HARMONY, and will be performed by collecting data from 150 patients across North America and Europe. The researchers who will be conducting the HARMONY study are from the Masonic Medical Research Laboratory in Utica, New York. The drug that Multaq will be tested alongside is Ranexa, which is a Gilead Sciences drug that is being used to treat patients who have angina. The HARMONY trial is going to the fourth clinical trial that will have included Multaq.
Of the first three clinical trials involving Multaq, only one — ATHENA — showed any positive results. The other two studies, named ANDROMEDA and PALLAS, had to be stopped after patients kept dying. Those patient deaths caused many doctors to stop prescribing Multaq unless it was used as a last resort. In addition, many healthcare professionals are calling for the drug’s overall recall.
For now, this new trial has some people wondering if there are going to be any extra safety precautions taken during the HARMONY study in order to avoid more patient deaths and another potentially halted study. So far, no such precautions have been announced.
Multaq was originally approved for use in July 2009. Within five months, the FDA had decided to issue a safety warning against Multaq when the increased heart attack risks became evident. The drug was also found to double the chances of patients suffering from strokes and heart failure and liver failure in AF patients. This HARMONY study is Sanofi’s newest efforts to prove that the drug is safe despite much evidence to the contrary. At this point it just seems as if Sanofi is just grasping at straws, but only time will tell if it will be the patients who will pay the price.
If you or a loved one has developed liver failure or a worsening of your heart condition after taking Multaq, contact the attorneys at Greg Jones today for a free consultation. We are experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.