Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious

Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events


ISSUE: FDA notified healthcare professionals that it is reviewing data from a clinical trial that evaluated the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation. The study was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving Multaq compared to patients taking a placebo. FDA is evaluating whether and how the preliminary results of the PALLAS study apply to patients taking Multaq for paroxysmal or persistent atrial fibrillation or atrial flutter. The PALLAS study results are considered preliminary at this time because the data have not undergone quality assurance procedures and have not been completely adjudicated. FDA will update the public when more information is available.

BACKGROUND: Multaq is approved for use to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.

RECOMMENDATION: At this time, patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation. Patients should not stop taking Multaq without talking to a healthcare professional. Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation. See the Data Summary in the Drug Safety Communication for additional details.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264204.htm

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

For any of you who have not gone to the Heart.org. You really need to review the PALLACE data. For no other reason than this company will not show this information. The CV outcomes were terrible and death and hospitalization was through the roof.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

So I would assume this to be another "Dear Doctor Letter".... CPR here we come...

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

People, how can we ethically promote this crap which was not properly researched? I refuse to be that robot without a heart. This is sad and scary.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

Who cares?

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

You should!

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

Absolutely you should care. You would care if it were a family member or good friend you know who is now on Multaq. Or you would care, if you were concerned about your credibility. But since you don't care, I can only guess that you are a Kool-Aid drinking DSM, RSD, or you are in Mulatq marketing and you're trying to figure out how to blaim the rep for all of this.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

You again? Don't you have some Mortal Combat tournament or something?

Why don't you leave this discussion to the folks that actually work instead of those that live off the scraps of SA legacy.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

Who cares?

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

You are one disturbed individual dude.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

Who cares?

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

This is the voice of this company.

We work for them because we like the money, the benefits and the 25 hour week. You can not say you have doubts about the harm this drug can do to some people. We take the money so we should shut up. I am not proud of it but i am not hypocrytical about it.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

25 hrs a week? i doubt you put in half that, does not matter, drug will be pulled shortly and you'll have plenty of time to not be proud collecting unemployment.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

Sorry, not Multaq rep. Will continue to collect paycheck and not be proud of working for a company that fights pulling a drug that kills people. Look, its not the first time we have sold a bad compound. We are also not the only company. So if you are proud of working for this company then good for you.

I am just saying that in this shitty economy. After doing this for double-digit years. With responsibility for sole support of a family. I am hanging on like many of us. I just don't think that coming on an anonymous board and verbally castigating the company while taking the paycheck is hypocritical. And I don't hope, or wish, you have to collect unemployment. I don't wish that on anybody in this economy. So stay righteous, proud, and employed

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

No problem killer. One thing though, work 40 hours a week or you're the hypocrite. Also, it is hypocritical not hypocrytical you slug.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

Poster you make some good points. I am a Multaq rep, have a great teamate, even better manager, but am fighting the mental side of this whole job... I try to do my best, but I cant be anything but honest with my customers and I hate having to be evasive and GET back to them with a Pharm D (KML) or have them call. Nobody can see 8 to 9 docs a day, so you just BS it and put in fake calls. This is not sales, has not been for years, and upper management does not inspire anybody. SO I stay employed, but its hard to be proud doing this, almost like stealing from a bank. The one thing it has done , got me to re-do my resume and actively look outside pharma.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

Unless driving around to justify being in the field is considered work, no one in sales works 40 hours in this industry. Work is the effort applied to produce a deliverable. do killer, no matter how you spell it, you are a hypocrite if you say you work 40 hours a week.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

You are a hypocrite, and you do not produce a deliverable.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

I left SA two years ago and I am relishing the way this company is imploding. My last three years there were a total nightmare. The upper management deserves to go down the tubes. Any of you still there after seeing the warning signs over the last two years are too dumb, lazy or stupid to survive. You deserve your fate.

 

Re: Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Seri

been here for many years and in many ways you are right. My problem is a big salary and I have tried to blast my 401k savings up. Knew it was coming and I got complacent. I am taking a huge risk - waiting for a package and timing another job within 3 months of the package. It will be hard and stressful but if it goes well I will make a lot of extra cash and I will be semi retired. We will see. So, you will either be calling me dumb, stupid, or rich in the near future.