Overview: Parker Waichman LLP, a national personal injury law firm, is warning the public that GranuFlo® and NaturaLyte®, two dialysis products manufactured by Fresenius Medical Care, are associated with serious risk factors for a heart attack and other cardiovascular issues. The products are acid concentrates used during dialysis, a process used to filter waste and excess water from the blood of a patient with lost or impaired kidney function. Fresenius came under scrutiny over GranuFlo® and NaturaLyte® earlier this year, when an internal memo showed that the company failed to alert the public about health risks associated with dosing errors.
- Fresenius’ GranuFlo® and NaturaLyte® are associated with alkalosis (high pH), which increases the risk of heart attack, sudden cardiac death and other heart problems
- Last year, Fresenius sent an internal memo warning its employees about the issue but never contacted the FDA or the public until the memo was discovered
- The FDA has issued a Class I recall of GranuFlo® and NaturaLyte®
Product: GranuFlo® and NaturaLyte®
Manufacturer: Fresenius Medical Care
Side Effects & Complications
- Metabolic alkalosis
- Cardiopulmonary arrest
- Low blood pressure
- Cardiac arrhythmia
Fresenius Failed to Warn about Issues Linked to GranuFlo® and NaturaLyte®
According to a press release by Parker Waichman, GranuFlo® and NaturaLyte® contain more acetate compared to other similar drugs on the market. In the body, the acetate gets metabolized into bicarbonate, an alkaline substance. Extra bicarbonate is often prescribed to dialysis patients in order to neutralize the acidity that builds up in the blood. According to an internal memo by Fresenius, this can lead to metabolic alkalosis if the doctor does not take the extra levels of bicarbonate into account. The memo, dated November of last year, also stated that over 900 dialysis patients suffered from cardiac arrest in 2010. Although Fresenius warned its own personnel about the risk of alkalosis associated with GranuFlo® and NaturaLyte®, it did not warn the public until prompted by the U.S. Food and Drug Administration (FDA), who received an anonymous copy of the memo.
FDA Issues Class I Recall
The FDA has issued a Class I recall on GranuFlo® and NaturaLyte®. A class I recall is the agency’s most serious recall status; it means that exposure to the product could lead to serious injuries or death. In recalling the products, the FDA warned that inappropriate dosing of bicarbonate may lead to alkalosis, which can increase the risk of “low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”