At the beginning of the year, Affsaps indicated that two patients under treatment with Multaq had to undergo a transplant after having observed a hepatic insufficiency, causing in particular a decrease in bile secretion by the liver. The health authority then recommended that patients treated with this drug (marketed in France since October 2010) to contact their doctor for any liver symptoms, such as abdominal pain, anorexia, nausea or dark urine.
These two cases of transplantation have taken place in Germany and the United States, but numerous cases of liver damage have been observed, and sometimes very soon after the start of treatment with Multaq.
On June 22, the health authorities (and more precisely the Transparency Commission) issued an “unfavorable opinion to maintaining inclusion on the list of reimbursable drugs” for Multaq. “The actual benefit [par le médicament] is insufficient to justify maintaining its coverage by national solidarity “ruled the body, responsible in France to assess the therapeutic interest of drugs offered for reimbursement.
And finally, yesterday it was the Minister of Health himself who announced that he would not oppose the delisting of Multaq, which was so far reimbursed at the maximum rate of Social Security, at 65%.
It remains to be seen whether the drug will continue to be marketed. The decision is the responsibility of the European Medicines Agency, which is currently studying the benefit / risk profile of Multaq.
