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Friday, July 22, 2011

Multaq (dronedarone): Increased Risk of Death or Serious Cardiovascular Events

Here's another in the class of dangerous drugs that are used to mask the symptoms of serious heart disease.  Have you noticed that very often, the drugs we are prescribed actually cause the problem that they are ostensibly designed to heal?

Take Multaq, for instance.  This drug is supposed to help patients who are experiencing "paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL)."  

Yet, in the same breath we are being told that there is a two-fold (200%) increase in deathAND, a two-fold increase, "in strokes and in hospitalizations due to heartfailure,"  compared to people who were given a placebo.

Folks!  Translated, this means that patients would be four-times better off doing nothing at all!

If you are concerned about heart health, stroke, atherolsclerosis... you really need to read this book, Practicing Medicine Without A License? The Story of the Linus Pauling Therapy for Heart Disease (Pauling Therapy Handbook).  Linus Pauling is the only person to ever have been awarded two un-shared Nobel Prizes.  And this book is definitely worth your careful attention!

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:

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