Millions of people all over the world depend on dialysis treatments to ensure their blood supply remains clean. Without the assistance of healthy kidneys, synthetic chemicals are used regularly to keep patients alive and free of sickness. Unfortunately, it was discovered that the largest manufacturer of these chemicals, Fresenius Medical Care, had been making two brands that carried severe risks with them. If you or a loved one has been taking NaturaLyte (the other medicine in question is GranuFlo), you should seek legal representation immediately as you may be entitled to damages.
Granuflo/NaturaLyte Has Been Recalled
First and foremost, you should be taking NaturaLyte only after speaking to your doctor about potential risks associated with it as it was recalled back in 2012. Originally, it seems Fresenius Medical Care changed the labeling on their product in such a way that it was seen as an attempt at a recall. However, this wasn’t good enough for the FDA, who initiated a Class I recall, the most serious kind that exists. The FDA sited that NaturaLyte could drop blood pressure dangerously low or even cause cardiac arrhythmia. Both conditions can be fatal.
The Problem with NaturaLyte
In order to replace the job of your kidneys, dialysis introduces chemicals into your bloodstream that essentially clean it of dangerous toxins. One of the chemicals that does this is bicarbonate. NaturaLyte works by giving your body medicine it can then turn into bicarbonate and use to clean the blood supply.
Plenty of medications do this. The problem is that the ones made by Fresenius Medical Care have twice the amount of the chemical used to make bicarbonate. It seems as though this wasn’t made clear to the doctors using it, meaning they were giving their patients twice what they needed with every dose. As studies have since shown, this can lead to cardiac arrest.
Unfortunately, that’s exactly what it did too. In 2010, alone, over 900 patients succumbed to heart attacks while they were in the care of Fresenius Medical Care facilities.
The Internal Memo
Who knows how long it would have taken to learn about this problem if not for an internal memo that went out in 2011. The medical department at Fresenius Medical Care had become aware of the threat posed by NaturaLyte and alerted their doctors that steps needed to be taken right away to address this problem.
That internal memo would be plenty damning all on its own. However, making matters worse is that the memo never made it to all the other companies using NaturaLyte. Something like 140,000 patients gets dialysis from third-parties using Fresenius Medical Care products. None of them were made aware of this newfound risk associated with NaturaLyte.
Fortunately, someone leaked the memo to the FDA who finally intervened. As we mentioned above, they actually imposed the strictest type of recall possible for NaturaLyte.
Disturbingly, many more may have suffered or even died had it not been for whoever anonymously sent the memo to the FDA. The company clearly knew something was wrong but, according to the medical department there, they didn’t have the means to alert their consumers. This is debatable, but certainly the products department at Fresenius Medical Care would have.
Another claim that the company has made is that there wasn’t enough evidence to mandate a voluntary recall. Again, this doesn’t add up. There was enough evidence to tell their own doctors, so clearly there was enough for telling others.
Speak with an attorney today if you believe you or your loved one suffered heart problems from using NaturaLyte. Obviously, Fresenius Medical Care has a lot to answer for and this could mean help with your medical bills and more.