Fresenius Medical Care, the maker of the dialysis solution GranuFlo® and NaturaLyte®, was aware of the risks associated with its dialysis products but failed to issue a warning to patients and doctors until 2012. The FDA issued a Class I recall on March 29, 2012, citing increased levels of serum bicarbonate, which caused cardiopulmonary arrest (heart attack, stroke and/or death).
Effects on Dialysis Patients Who Were Given GranuFlo® and NaturaLyte®
GranuFlo® and NaturaLyte® have been proven to cause up to a 600% increase in the risk of cardiac arrest and stroke. In November 2011, an internal memo at Fresenius Medical Care revealed the company knew the drug caused a significant increase in risk of cardiac arrest in patients given dialysis using GranuFlo® and NaturaLyte®. Fresenius Medical Care issued a warning to its own dialysis clinics for doctors to be aware of the danger when prescribing medication doses, but the company failed to alert any of the other facilities using Fresenius products.
Fresenius Medical Care’s failure to alert other clinics and physicians is significant because the company provides equipment and supplies to 1/3 of the 400,000 patients in the United States who receive dialysis treatment. Fresenius only cooperated in the wide-spread safety alert after the FDA was tipped off about the memo in March 2012 and questioned Fresenius about the safety of its products.
Even now, Fresenius has publicly emphasized that no products will be removed from the marketplace. Instead, company officials say the company will continue to place updated labels on it products and update its dialysis machine manuals. However, much of the damage has already been done for dialysis patients who have experienced adverse health effects of the drug. Adverse effects of the drug include:
- Heart attack
- Cardiac Arrest
- Low blood pressure
- Hypokalemia (low potassium levels)
- Hypoxemia (low levels of oxygen in the blood)
- Hypercapnia (too much carbon dioxide in the blood)
- Cardiac arrhythmia (an irregular heartbeat that is too fast or too slow)
Fresenius Medical Care put profits ahead of people when they decided to mislead and hide critical information about the hazards associated with its products. Shockingly, Fresenius Medical Care still aggressively markets GranuFlo® and NaturaLyte® and can be found at thousands of dialysis centers around the country.
If you or a loved one have suffered sudden cardiac arrest, stroke or death do not hesitate. Contact us now at 1-888-690-0211, for a free evaluation of your claim.