Multaq: Don’t Ignore These Safety Signals

| January 28, 2013
MULTAQ

Multaq – still considered safe despite its life-threatening side effects

Would you take a drug if you knew this about it:

  • “Multaq doubles the rate of cardiovascular death, stroke, and heart failure” in patients with permanent atrial fibrillation (AF) – the American Food and Drug Administration (FDA).
  • “A clinical study in patients with permanent atrial fibrillation (AF) and cardiovascular risk factors was stopped early due to an excess of cardiovascular death, stroke and heart failure in patients receiving MULTAQ.” – Sanofi (Multaq’s manufacterer) website.

Despite it’s terrible safety profile and trials being stopped early because of patient safety, Multaq (Dronedarone) was approved in the UK and Europe back in 2010, and is prescribed as an antiarrhythmic drug (for the treatment of abnormal heart rhythm or AF) with a recommended dose of 400 mg twice daily.

When you look at the facts, the mind boggles as to why this drug was  allowed on the market in the first place?

The issue with Multaq is not that its manufacterer withheld any drug trial data prior to its release. In fact on their website, Sanofi has published comprehensive and extensive information about Multaq’s drug interactions, side effects, clinical trial results and contraindications. However, the real point of concern is that the medical authorities are fully aware of this drug’s dangers, which aren’t mild side effects or minor adverse reactions… and yet in typical Big Pharma style, they turn a blind eye.

Shortly after Multaq’s approval in the UK, a US Institute for Safe Medicine Practices (ISMP) investigation linked Multaq to potential impaired kidney function and fatal irregular heartbeats.

The ISMP concluded: “We have seldom seen a drug with so many issues in so many areas of its safety profile.”

And they are right. Stroke, heart failure, kidney failure and death aren’t ‘side effects’ to take lightly.

Was Multaq removed from the market as a result of the ISMPs investigation? No.

In fact, a year later a Europe-wide review of the risks and benefits of treatment with Multaq began in January 2011 because of concerns over reports of liver injury, including two cases of liver failure requiring transplantation.

Following the review, medical authorities concluded that the benefits of treatment with Multaq continue to outweigh the risks!

Patients on this medication are also advised to have an ECG every three months and they should also receive appropriate antithrombotic therapy. (Antithrombotic therapy refers to the use of medications which interfere with blood clot formation). That’s apart from the fact that they should also have regular monitoring of cardiac, liver, and renal function during treatment.

Who in their right mind would take this drug? More importantly, why is this train wreck of a drug still on the market? It certainly can’t be because it is saving lives…


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Sources:

“FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events” FDA Safety Announcement, 12/19/11, fda.gov

“FDA revises Sanofi Multaq label on heart risks” Anna Yukhananov, Reuters, 12/19/11, reuters.com

“Effect of Dronedarone on Cardiovascular Events in Atrial Fibrillation” New England Journal of Medicine, Vol. 360, 2/12/09, nejm.org

“Heartstopping News? More Multaq Safety Signals” Ed Silverman, Pharmalot, 11/8/10, pharmalot.com

Dronedarone (Multaq▼): cardiovascular, hepatic and pulmonary adverse events – new restrictions and monitoring requirements, published online October 2011, mhra.gov.uk/

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Category: Drugs On Our Radar

Comments (3)

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  1. Marlene says:

    If stroke, heart failure, kidney failure and death are ‘side effects’ of this drug then these guys are guilty of manslaugher!

  2. Erin says:

    Did you see what GSK is up to in China? these pharma companies have no shame.

  3. Adam says:

    Thanks for flagging up the dangers of this drug. I wonder for how long the mainstream is going to try and keep it under wraps.