GranuFlo, Granultye And NaturaLyte Linked To Increased Risk Of Death
The Food and Drug Administration (FDA) issued a Class 1 recall, the most serious recall, of GranuFlo and NaturaLyte in March 2012, citing its potential to cause death. According to an internal memo from the manufacturer (FMC), hemodialysis patients who were administered GranuFlo were six times more likely to suffer a cardiac event or cardiac arrest.
If you lost a loved one who suffered a heart attack while taking GranuFlo, you may have a defective drug claim against FMC for personal injury or wrongful death for your losses.
At the law firm of Abraham, Watkins, Nichols, Sorrels, Agosto & Aziz, our Houston attorneys have represented victims of defective and dangerous drugs throughout Texas for more than 65 years. We have the knowledge and experience to hold medical companies responsible when their products or services seriously injure or cause the death of a family member. Contact our law firm online or at 713-587-9668 to schedule a free consultation.
Dialysis Injuries Caused By GranuFlo
Cardiac death is the number one killer of dialysis patients, accounting for nearly 60 percent of deaths among those receiving treatment for acute or chronic renal failure. FMC knew that a serious cardiac event was a potential side effect of GranuFlo and NaturaLyte, but it failed to warn patients or their treating physicians of the dangers of the defective drug.
GranuFlo is a dry powder and NaturaLyte is a liquid. Both GranuFlo and NaturaLyte are used during hemodialysis and peritoneal dialysis to control the pH of a dialysis patient's blood. During dialysis, either GranuFlo or NaturaLyte are combined with other ingredients to create the dialysate that is used to remove toxins from the blood. When a patient is connected to a dialysis machine, the machine functions in place of his or her kidneys, using the dialysate to clean the blood and then return it to the body.
One of the by-products of GranuFlo is bicarbonate. Overdosing on bicarbonate can cause:
- Metabolic alkalosis
- Cardiac arrhythmia (an irregular heartbeat)
- Low blood pressure
- Heart attack or myocardial infarction
- Cardiac arrest or cardiopulmonary arrest
- Sudden cardiac death
GranuFlo and NaturaLyte contain more of the ingredient that is converted to bicarbonate than other similar products on the market, which creates the increased risk for bicarbonate overdose and a fatal heart attack. Bicarbonate levels should be closely monitored to ensure that GranuFlo is not causing a bicarbonate overdose.
Was A Loved One Treated With GranuFlo While Undergoing Dialysis?
You may not know if you or a loved one received one of the recalled dialysis drugs. GranuFlo and NaturaLyte have been widely used in both Fresenius and non-Fresenius clinics. There are at least three FMC dialysis units in Houston:
- Fresenius Medical Care Midtown
- Fresenius Medical Care Westminster
- Fresenius Medical Care Dialysis Services of Meyerland
Fresenius notified its own clinics of potentially fatal side effects of GranuFlo in the Fall of 2011 but did not notify any outside clinics until the FDA recall in March 2012. If your family member died during or shortly after a dialysis treatment or you or your family member suffered a heart attack during dialysis, you may have been administered GranuFlo.
Contact Our Houston Law Firm For Answers
If you have lost a loved one due to a fatal heart attack after he or she went through dialysis, chances are that he or she received some form of the recalled defective drug GranuFlo. Contact our Houston, Texas law firm to learn about your right to compensation for your losses from a medical company that failed to warn you or your family member of the risk of its products.