Designed for use during kidney hemodialysis, GranuFlo Dry Acid Concentrate has recently been linked to serious GranuFlo side effects including heart arrhythmia and sudden cardiac arrest.
Fresenius Medical Care, the manufacturer of GranuFlo, allegedly knew about the potential for increased risk of cardiovascular problems, but failed to alert physicians outside their own centers until five months after informing their own physicians. Patients who experience serious injuries after hemodialysis with GranuFlo may be eligible for a GranuFlo lawsuit.
Doctors Unaware Of GranuFlo Side Effects
Kidney patients often take prescriptions of bicarbonate to help control the acid in their blood. During hemodialysis, which cleans the blood of waste, doctors also use concentrates like GranuFlo, which is converted into bicarbonate to further reduce acid buildup.
Many doctors were unaware, however, that GranuFlo could increase bicarbonate levels more significantly than other products. An excess increase in bicarbonates can lead to metabolic alkalosis, a pH imbalance in the body. Metabolic alkalosis can lead to heart problems like low blood pressure, arrhythmia, and even cardiac arrest.
Patients Treated With GranuFlo Put At Unnecessary Risk
On November 4, 2011, Fresenius Medical Care released an internal company memo. They described a case-control study that evaluated risk factors in 941 patients who suffered from cardiac arrest during kidney dialysis in 2010. They found that high bicarbonate levels were an independent risk factor in these deaths, and that levels were more likely to be high in patients treated with GranuFlo.
Fresenius noted that doctors had failed to adjust patients’ outside prescriptions of bicarbonate when switching to GranuFlo, failing to account for the higher levels of ingredients that may lead to bicarbonate buildup. GranuFlo can raise bicarbonate levels more than other products, risking metabolic alkalosis and serious GranuFlo side effects.
FDA Investigation Prompts New Alert
A GranuFlo lawyer is likely to feel that Fresenius should be held liable for failing to expand their warning about GranuFlo side effects until March 29, 2012. It was not until the FDA anonymously received a copy of the internal November memo and asked the company about it that Fresenius released a broader notice to medical directors and nursing home managers.
On May 25, 2012, the FDA added its own warning to physicians regarding dosing errors with GranuFlo. On June 27, 2012, they issued a Class I recall for the product, noting that it may cause serious adverse health consequences, including death.
A GranuFlo Lawyer Can Help
If you suffered a serious cardiovascular injury after going through dialysis and your doctor used GranuFlo, you may benefit from a consultation with a GranuFlo lawyer. A thorough review of the case may reveal claims that can be made against the manufacturer. If successful, a GranuFlo lawsuit could result in monetary compensation. Contact Chaffin Luhana LLP for a free and confidential case evaluation at 1-888-316-2311.