In March 2012, the FDA initiated a Class I recall of NaturaLyte and GranuFlo, two products manufactured by Fresenius Medical Care that are used with kidney dialysis treatments. This is the most serious recall the FDA issues, and is generally used in conjunction with products that lead to the development of serious, or potentially even fatal, health conditions.
The recall was issued due to an increased risk of developing metabolic alkalosis when these dangerous drugs are used with kidney dialysis treatment. Metabolic alkalosis can result in serious cardiovascular conditions such as:
- Heart attack
- Cardiac arrest
- Cardiac arrhythmia
- Low blood pressure
- Cardiopulmonary arrest
- Sudden cardiac death
These conditions are caused by certain ingredients in NaturaLyte and GranuFlo increasing the levels of bicarbonate in the bloodstream beyond what is normally expected with kidney dialysis products. Since doctors were not aware of these increased bicarbonate levels, many patients received dosage errors that placed them at risk of developing serious cardiovascular conditions.
An internal Fresenius memo released to the FDA in March indicates that the pharmaceutical company was aware of these risks for more than 15 months prior to notifying the FDA. Yet the company never informed doctors or other hemodialysis clinics that used these products. This grossly negligent behavior likely resulted in thousands of people suffering serious, potentially fatal injuries.
If you or a loved one has been injured after receiving kidney dialysis treatment using GranuFlo or NaturaLyte, you may be entitled to receive compensation for your damages. The Alabama pharmaceutical injury lawyers at Long & Long have more than 30 years of combined experience handling complex defective drug cases, and we possess the resources necessary to level the playing field against the high-powered legal teams employed by pharmaceutical companies.
Please contact Long & Long today to schedule your free pharmaceutical injury consultation. We serve clients in Mobile, Alabama.