Since its approval last year, the Sanofi-Aventis Multaq heart drug has been controversial. For instance, a study published last spring found the pill is only modestly effective and has no clear safety benefits (see this) and more recently, questions were raised about the study that led to FDA approval ( look here).
Now, a new analysis of FDA adverse event reports indicate Multaq may cause or worsen heart failure, trigger potentially lethal irregular heartbeats and impair kidney function. There is also a glaring discrepancy between the language in the Med Guide given docs and patients, and the warning label about pregnant patients. And the findings led The Institute for Safe Medicine Practices, which conducted the analysis, to conclude that "we have seldom seen a drug with so many issues in so many areas of its safety profile."
Why? The non-profit points out that development stopped several years ago after a study of patients with severe heart failure found the drug doubled the risk of death; other data found signals of cancer and birth defects in animals; there are potentially serious interactions with other drugs used to treat atrial fibrillation, and Multaq causes new heart rhythm disturbances in some patients.
In its analysis, ISMP found 387 domestic serious adverse events cited Multaq as he primary suspect in reports involving 24 deaths, two cases of disability, and 361 other serious reactions. Overall, 25.8 percent indicated new or worsened heart failure. "This was of concern given that worsened heart failure was identified as the reason for increased mortality in the company’s trial in heart failure patients; the current prescribing information cautions doctors to consider discontinuing or suspending the drug if heart failure develops," ISMP writes.
Heart rhythm disturbances were also reported, including 18 potential cases of abnormally slow heartbeats, 47 cases of rapid heartbeats and 13 cases of ventricular tachycardia. ISMP says this was determined after noticing earlier this year that Multaq accounted for more reported cases of these kinds of rhythm disturbances than any other drug it monitors. There were also 15 cases of kidney failure or impairment, including four cases of acute kidney failure, but computer excerpts did not provide sufficient info to evaluate them, ISMP reports.
And so ISMP asked Sanofi-Aventis for a reply and this came back: "The company said it believed that some studies showed that the reporting rate for adverse drug events may be higher during the first two years after introduction." In other words, wait a few years and adverse events may drop? The drugmaker acknowledged, though, that the FDA is evaluating "at least two signals" in the adverse event data - heart failure and Torsades de Points, a lethal form of ventricular tachycardia.
One final note: ISMP found the Medication Guide has a "serious lapse." The non-profit notes the FDA classified Multaq is teratogenic, or a risk for pregnant women. The label says: Multaq may cause fetal harm when administered to a pregnant woman...(and) is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus."
Yet, the Med Guide says: "It is not known if Multaq will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant." ISMP writes that "we raised this issue with Sanofi-Aventis, which told us the company believed the current wording was appropriate."
25 Comments
Any heart failure should be analyzed quickly and can not continue with a drug or an analgesic for pain, definitely good for the FDA is still evaluating the product and perform quality control often can rely on this drug We market and are approved in the U.S. by the regulator.
David Garrard Findrxonline
Yet more evidence to support that new treatments should be approached with great caution. This one looks like a 3-5 year window will be all that is needed to better understand the risks. When it comes to medicines, newer is (increasingly) rarely better.
If the FDA actually studied the Adverse Events Reports connected with many of these major drugs they would have to pull the drugs off the market. But with the FDA so deeply in the pockets of the pharmaceutical industry this is not going to happen any time soon. And I completely agree with M Helm, MD that newer rarely seems to be better these days when it come to pharmaceutical products.
By the way, a little plug here, please take a look at my website PrescriptionDrugProblems.com for two recent Ebooks about prescription drug overdose and prescription drug addiction.
This is the usual process followed by most conventional medical drugs. First, they are fast tracked to approval because they have such amazingly beneficial results. Then, and only after 1000s or millions of patients suffer, it is discovered they cause disease and death.
All ConMed drugs should be avoided, and safer medical therapies found, like homeopathy.
Sometimes it does take time to elicit the full profile of an antiarrhythmic drug. The Cardiac Arrythmia Suppression Trial (CAST), begun in 1989, was a large postmarketing trial of standard anti-arrythmia drugs, which showed that a number of these drugs promoted arrythmias rather than suppress them. Thus, if you study them closely, many of the agents in this category of drugs have been problematic.
http://www.nejm.org/doi/full/10.1056/NEJM198908103210629
I have been on multaq 2 days. It has made me feel very ill. Dizzy,faint, upset stomach nervous. I am stopping it immediatly!!!
My doctor switched me from Rythmol to Multaq and I immediately had increasingly severe diarrhea, and went from a mild episode of arrythmia every ten days or so on the rythmol to very strong episodes almost every day. I felt terrible all the time. I knew it wasn't good for me almost from the beginning, but my doctor kept saying it would get better and sometimes it just took a while for it to kick in. Then I developed a severe, terrible incredibly itchy skin rash from mild exposure to the sun, which I have never had any sensitivity to at all, so I told him I wasn't going to take it any more and wanted to go back to the rythmol. I can't tell you how much better I felt within a couple of days. I was on it for about a month in all, and I didn't really realize how bad I felt until I stopped taking it and felt so much better..
when the pharmacuetical companies say the benefits outway the risks and they always do say that,they are talking about their profit.they may be sued for millions of dollars but they will make hundreds of millions of dollars in profit.(except here in michigan)our elected prostitutes passed a law that guards the pharmaceutical companies against lawsuits.
Please contact your doctor if you have or have had any lund disease in the past...my grandfather recently passed away due to an adverse reaction of lung toxicity from multaq that was not "known" to the company..the doctors have told my family that it will be pulled from the market, but has yet been done...so just be careful when taking the drug
I had Cardioversion on Dec 22nd of this year 2010. The doctor put me on Multaq, taking 2 tablets @ 400mg twice a day. Kind of worries me after reading other comments. I am a very healthy 82 year old that works out at the gym three days a week on bike, tread and weights with no dizziness or weakness ever. I had my first cardioversion in October of 2009, it lasted for 11 months, while also taking the same amout of Multaq with no problems. The only disappointment was that it didn't last longer. Kind of makes you wonder as to which doctor is right, or which medicine is less detrimental.
I am a 40yr old male. I took Multaq from May 2010-July 2010. Only side effect for me was skin sensitivity while in the sun. I live in CO so sun is intense at our altitude. I have since been taken off as I have successful mitral valve repair 3 weeks ago at the Cleveland Clinic. Now dealing with post op Atrial tachycardia. Its annoying but supposedly not dangerous.
Have been on multaq sine Dec.2009 (March2011). I have had excessive weight gain plus dizziness since taking this drug. I have also suffered with constipation.
I'm a 50y/o diagnosed Nov. 2010 and started on Rythmol, had horrible side effects of extreme fatigue, continued arrythmias, thigh pain, and a feeling of a tight band around my chest. Was on it for 1.5 months, switched to Multaq and my symptoms diappeared in 2 days and I haven't felt this good in a long time! I can breath, my muscle pain disappeared totally and I have more energy than I've had in months. I do worry about liver damage and other mentioned issues so will have labs monitored periodically and just see how it goes.
I'm 70 y/o diagnosed with AFib in 2007,same symptoms misdiagnosed twice in 2004. Was put on diltiazin in 2008 and symptoms of fatigue, light-headedness, inability to function well became continually worse to where I was spending about 1 day out of every week in bed. Have been on Multaq now for 6 mo. and though sometimes quite tired, have not had to spend any daytime in bed during this time. I'm attributing 10-15 pound weight gain and some muscle aches in forearms and calves as side effects of this drug....like the previous commentor (Candi), I will have the potential for liver damage monitored.
I was put on multaq in the spring or summer of 2010 after having several a-fib ocurrences in a 3-month time frame.After 6 weeks or so on multaq i starting experiencing all the bad symptoms the drug info said to immediately inform your doctor about.I sudenly couldn't breathe and was weak,agitated and sweaty.My wife had to drive me to emergency where they knocked me out and inserted breathing tubes for 28 hours.I spent 4 days in the hospital and i believe i would have died had i not gone to emergency.
My husband was put on Multaq in October 2009 after cardioversion. He had had a Ablasion done in March 2007, which helped but not as successful as hoped. He had some weight gain, but he felt very good for several months. In January 2011 for whatever reason his heart went out of rythm, enlarged, and he passed away. Did the Mutlaq not do it's job???,
I'm a 52 yr old male....recently had a stent...I was given Multaq for irregular heartbeat....I have been taking multaq for several weeks...3 weeks ago out of the blue my arms swelled up, turned fire red and so itchy it made me cry...I'm also on blood thinners so everytime I would scratch the rash....It would open up and bleed...I have been been to the doctor and have been give predisone cream to releive the rash....I have been told that Multaq is to blame so i'm not going to take it anymore...there has to be something better out there....so if anyone has these symptoms odds are its the Multaq....
I tried taking Multaq & took 3 pillls & was in bed sick for 4 days. I quit taking it. Now my sister is in the Hospital in the ICU unit with Congestive Heart Failure & has been on Multaq for 7 months. We both have A-Fib (inherited) and never any history of Congestive Heart Failure. My sister has "every" side effect of the Multaq & they still try to give her the medicine! We are now fighting to keep her alive!
I posted on 7/26/11 about my sister. Well NOW she has kidney failure and was put on dialysis yesterday evening. We are now fighting to save her life!
Today my cardiologist wrote out a prescription for Multaq, 400mg twice a day. After reading all the comments about this drug, I am afraid to take it! I have paroxysmal atrial fibrillation, and am currently taking Metoprolol, 100mg a day, and my doctor said I should decrease it to 50mg daily while taking the Multaq. I noticed most of the comments posted are negative regarding this medication. My family said that I should not even think about taking a drug that can potentially cause severe reactions and even death. I think I will not take this medication and listen to my family and friends.
My husband passed away in June 2011,he was taking Multaq since December 2010. Never did feel good while taking.He developed congestive heart failure ,liver failure and kidney failure. all this was acute. I am sure this drug killed him and needs to be taken off the market
I have been taking Multaq for 3 months. I read in the WSJ last week about Multaq concerns. I spoke to my doctor on 9/26/11. I have not had any noticeable side effects but I was very concerned abojut liver damage. The doctor decided to discontinue the drug as Multaq has not been shown to be beneficial in permanant A-Fib.
I was recently put on Multaq because the anti-rhymthic I was taking, caused me to have a heart attack. But I too can not take it! My eyes burn like they are on fire especially in bright light. My heart also beats wildly. This is not for me!!!
My Multaq legacy involves weakness, fatigue, spaced out feelings, brain dead fog, memory problems, terrible sleep patterns, eyesight problems, stomach issues, and constantly feeling just plain sick. It's been a nightmare, but all I hear back when I mention all of this is "well, at least you're not in Afib."
Poor tradeoff - sorry. I can't see being this way the rest of my life. I'll take my chances going back into occasional Afib.