As of March 2012, the Food and Drug Administration (FDA) has been monitoring Fresenius Medical Care (FMC), due to several anonymous accusations that its dialytic drugs known as Ganuflo and NaturaLyte cause significant health risks. After beginning its investigation, the FDA discovered that FMC had previous data and knowledge of the potential health risks, but had kept it within the company instead of sharing the life-saving information with the public. According to an article in the New York Times, the FDA even found an internal memo—dated the year before—warning doctors within the company that “failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.”
Needless to say, the FDA was less than pleased with this discovery. Steven Silverman, the director of compliance for the FDA’s medical devices division, was quoted to have said in an interview that he was “personally troubled by the fact that Fresenius, on its own initiative, didn’t notify its entire customer base of this particular concern.” He later stated that it was “bad business” to keep such health risks from the public.
Unfortunately, as a result of withholding this information, many patients have suffered—and many still are. Are you one of the many?
Symptoms of Increased Bicarbonate Blood Concentrations
The FDA issued a Class I recall, but the medications are still being used, with the stipulation that the manufacturer replaces their labels with new ones that caution clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained within the medication. Unfortunately, the drug itself has not been replaced, and the bicarbonate by-product concentrations are still prevalent. This means that inappropriate prescriptions can still lead to a high serum bicarbonate level in patients undergoing hemodialysis—which in turn can contribute to metabolic alkalosis and death.
This is why it is extremely important to recognize any negative effects of your medication as soon as possible. If you experience any adverse reactions while on dialysis, especially if you are aware that you’re using Granuflo or NaturaLyte, get medical attention immediately.
Types of adverse reactions include:
- Prolonged muscle spasms, muscle twitching, or hand tremors
- Nausea or vomiting
- Numbness or tingling in the face, hands, or feet
- Muscle cramps
- Changes in breathing
- Increased need to use the chest and abdominal muscles to breathe
- Flushed skin
- PVCs – Abnormal changes in heart rhythm
- A fluttering in your chest
- A racing heartbeat (tachycardia)
- A slow heartbeat (bradycardia)
- Chest pain
Toxic Consumerism: How Do You Feel About Being Blindsided?
Given the potential risks involved, do you think it’s appropriate for doctors to continue using Granuflo and NaturaLyte for dialytic treatments? Do you think the FDA should force an actual product recall to get it off the market? Should Fresenius be fined for keeping the truth from its consumers?
What do you think? In the comment section provided, let us know how you feel about these dangerous effects and how they may have affected your life.
Need more information about joining the lawsuit? Contact us today for a free consultation. We’ll be more than happy to explain your rights and options.