Multaq FDA Warnings Over Heart Problems
The FDA has issued new warnings about the potential risk of Multaq side effects, indicating that doctors should no longer prescribe the drug to patients with permanent problems with abnormal heart rhythms, as that may double the risk of death, stroke and other heart problems.
Earlier this week, the agency finished a safety review of Multaq and announced that it is making label changes, as well as recommending limits on Multaq use. The FDA also said that it was looking at whether the risk of heart problems from Multaq is so severe that it outweighs the benefits. If the agency finds that to be true, FDA officials could call for a Multaq recall.
Even though Multaq has only been on the market since July 2009, it appears as though federal drug regulators are questioning whether it ever should have been approved. Earlier this year, the FDA chastised Sanofi, the manufacturer, for failing to notify health officials that it knew of reports of Multaq liver damage. Two Multaq users had to undergo liver transplant operations after liver failure believed to be linked to the drug.
Then this summer, Sanofi cancelled clinical trials involving Multaq after too many of the human test subjects began dying. Sanofi hoped that the trials, PALLAS would show that Multaq was safe and effective in the treatment of permanent atrial fibrillation. Instead, they found that twice as many Multaq users died or suffered strokes and heart problems than those given a placebo. Multaq is currently only approved to treat temporary atrial fibrillation.
The Multaq FDA review was launched after PALLAS was cancelled. The agency is now warning doctors to avoid giving Multaq to permanent atrial fibrillation patients, and also wants them to stop giving Multaq to patients while they are in an episode of atrial fibrillation, even if it is temporary. To ensure patient safety, the FDA urges doctors with Multaq patients to monitor their heart rhythms at least every three months.
MULTAQ HEART LAWSUITS
The Multaq lawyers at Saiontz & Kirk, P.A. are reviewing potential claims nationwide by individuals who have taken Multaq and suffered heart problems or liver damage that may have been caused by Multaq. It appears that Sanofi-Aventis failed to properly test Multaq before releasing it on the market, and also failed to provide adequate information to doctors and patients about Multaq risks such as liver problems, heart attack, stroke or sudden death.
Potential Multaq lawsuits are being reviewed for individuals throughout the United States and there are no attorney fees unless a recovery is obtained. To review a potential lawsuit for yourself, a friend or a family member, request a free consultation and claim evaluation.
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