Pharmaceutical Lawsuits in the News: Was Multaq Approved by the FDA Too Soon?

Pharmaceutical Lawsuits in the News: Was Multaq Approved by the FDA Too Soon?

Pharmaceutical Lawsuits in the News: Was Multaq Approved by the FDA Too Soon?

Although, to date, no class action lawsuits have been filed against the makers of Multaq, Sanofi-Aventis, there are currently individual lawsuits that have yet to receive an official settlement offer and the number of suits being brought against the manufacturer is mounting exponentially. Like many other ‘wonder drugs,’ some experts are saying that Multaq was approved by the FDA too early without adequate research or clinical trials and so this leaves the question, was it really approved by the FDA too soon? A bit of background information may help you decide for yourself.

Multaq Approved by the FDA in 2009

One of the contributing factors to a growing number of Multaq lawsuits is the fact that the FDA approved the drug in 2009 and by early 2011 complaints were already mounting. Two people suffered severe enough liver damage to require transplants, the cause being cited as dronederone, the generic name for Multaq. This is only after having been on the medication for a few months and not over a long period of time that is typical of drug related liver failure. Within just about one and a half years, patients were already suffering severe consequences.

Liver Failure Is Only One Serious Side Effect

In 2011 the FDA mandated the first black box warning be printed on packaging and shortly thereafter a second black box warning was also ruled necessary. It was the FDA’s findings that the drug could possibly pose other health-related risks such as:

  • Stroke
  • Cardiac arrest resulting in death
  • ILD – Interstitial lung disease
  • Blood clots
  • Inflammation of the blood vessels
  • Pulmonary toxicity
  • Heart failure requiring hospitalization

These are serious side effects, many of which require immediate and long term medical attention. With the risk of death looming in the air and due to the fact that these risks were observed only after the drug was approved, many question whether or not the FDA simply streamlined the approval process before having all the statistical data to make a well-informed decision.

The Likelihood of a Class Action Lawsuit Exists

Although no one is prescient enough to know whether there ever will be a class action lawsuit, it stands to reason that there is every likelihood for this to happen. Based on previous pharmaceuticals that posed similar risks, many believe that such a case will inevitably evolve because the drug is still being prescribed and sometimes for the very same patients who are at greater risk per the FDA’s warnings. For example, Multaq is meant to normalize the heart rhythm in a patient who doesn’t have a permanent diagnosis of irregular heartbeats. This is a drug that is not meant to treat patients with a history of arrhythmia but rather those with a newly developed and perhaps temporary diagnosis.

You Are Not the First to Question If Drugs Are Being Approved Too Quickly

Way back in a 2012 Forbes online publication, the author questioned whether the FDA was making hasty approvals. It is the contention of that author that a great deal of pressure is placed on the FDA by big pharma and as a result, they are speeding up the approval process. On the other hand, the FDA is also tackling citizens’ advocacy groups who are lobbying for the latest treatments to be released quicker in the hopes of saving lives with new products and technology. This leaves the FDA between the proverbial rock and hard place because on the one hand they are being urged to speed up the process but on the other hand are criticized when something goes wrong as it invariably does when sufficient trials haven’t been undertaken.

What You Can Deduce

Actually, it is logical to deduce from the above that Multaq was in reality approved too quickly by the FDA but can they bear the brunt of fault? When big pharma is pushing them to approve new drugs and patients’ advocacy groups are urging the release of new medications to offer new hope in treating their illnesses, it would be unfair to place the entire ‘blame’ on the FDA. However, as the government watchdog that is supposed to protect the public from situations like this, it would perhaps fall on them to be stronger in refusing to rush things through due process.

So yes, the FDA probably did release Multaq much too quickly but in an effort to save lives based on initial results provided by the makers of the drug. Should more tests and research have been conducted? Absolutely! Maybe this will be a lesson well learned going forward when presented with other drugs and even when being pressured to streamline the process. Safety can’t be rushed.

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