Consumer Alert: GranuFlo and Naturalyte May Create Risk of Heart Attack for Kidney Dialysis Patients
The Milwaukee drug injury lawyers at Techmeier Law Firm of Wisconsin are investigating potential lawsuits for personal injury and wrongful death caused by the kidney dialysis drugs GranuFlo and NaturaLyte.
GranuFlo and NaturaLyte help neutralize acid that builds up in the blood during dialysis treatments. But the U.S. Food and Drug Administration says they have dangerous – and potentially deadly – side effects, including an increased risk of heart attacks.
As a result, the FDA in June 2012 issued a Class I recall of both drugs. Class I recalls are the most urgent type of recall, issued only when use of a product might result in serious injury or death.
Techmeier Law Firm of Wisconsin represents people who have been injured by dangerous drugs and defective medical devices. Its dialysis injury lawyers offer free and confidential case evaluations to patients who underwent dialysis with either GranuFlo or NaturaLyte and suffered any of the following symptoms:
- Heart attack
- Cardiovascular death
- Blood irregularities
- Cardiac arrhythmia (irregular heart rate)
- Hypoxemia (low blood oxygen)
- Cardiopulmonary arrest
- Other adverse consequences.
GranuFlo Heart Risk In Dialysis Treatment
Dialysis is used when a person’s kidneys don’t work properly to remove toxic waste from the blood system. The process requires bicarbonate to neutralize acid that can build up in the blood. GranuFlo and NaturaLyte are concentrates that are converted into bicarbonate. GranuFlo comes in powder form and NaturaLyte is a liquid. They contain higher levels of bicarbonate than other brands of similar drugs.
As a result, the drugs must be carefully administered so that the patient does not receive too much bicarbonate. A bicarbonate overdose can cause alkalosis, a pH imbalance that might lead to cardiovascular death and catastrophic heart injuries.
Warning signs of a GranuFlo or NaturaLyte complication might include:
- Chest pain
- Weakness in the arms or legs
- Vomiting blood
- Muscle cramps
- Muscle weakness
- Shortness of breath.
FDA Recalls GranuFlo and NaturaLyte
GranuFlo and NaturaLyte are manufactured by Fresenius Medical Care, which provides treatments in its dialysis centers to approximately one-third of the estimated 400,000 dialysis patients in the country.
In November 2011, Fresenius sent an internal memo to physicians at its own dialysis clinics warning that improper dosing of GranuFlo appeared to be contributing to a rise in the number of patients dying from cardiac arrest, according to the New York Times. Fresenius’ own experts determined that nearly 1,000 patients had suffered heart problems in its clinics in 2010, and that patients with high levels of bicarbonate in their blood were at an approximately six times higher risk of cardiac arrest as those with lower levels.
But these warnings were not conveyed to patients at Fresenius clinics, nor were they conveyed to dialysis centers that used GranuFlo but were owned by other companies.
Following the New York Times report, the FDA began investigating Fresenius for possible violations of federal regulations for failing to inform patients about the serious heart risks associated with GranuFlo and NaturaLyte.
According to the FDA’s recall notice:
“Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with 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.”
Get A Free Consultation With a GranuFlo Injury Lawyer
If you or a family member has experienced a heart attack, blood irregularities, convulsions, stroke or other complications following kidney dialysis in which GranuFlo or NaturaLyte were used, you may be entitled to compensation. Contact us at 800-242-1050 to discuss your legal rights and options with an experienced Milwaukee drug injury attorney. Techmeier Law Firm of Wisconsin will put its winning reputation and decades of experience to work for you. The call is free and confidential. You pay no attorney’s fee unless you win your case.