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NaturaLyte & GranuFlo – Heart Attacks and Other Side Effects

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Kidney patients receive hemodialysis and peritoneal dialysis as treatments, but dialysates GranuFlo and NaturaLyte used in these procedures can cause fatal heart attacks.

When functioning properly, human kidneys remove toxins and waste from the blood by acting as a filter and producing urine. If these organs fail, toxins and excess minerals and fluid overwhelm the body. Dialysis can partially replace kidney function and help remove waste from the blood. According to the latest statistics available from the Centers for Disease Control and Prevention (CDC), about 400,000 Americans with kidney failure were on dialysis in 2009.

Dialysis – a medical procedure that filters blood when kidneys can’t – serves as a primary treatment for kidney failure, but this life-saving procedure is not without side effects. Some of these complications occur because of contaminated dialysis tubes or because of poor health or age of the patient. Older patients generally have more risks than younger patients, and kidney failure is more common in adults over 70. Other complications may occur because of drugs called dialysates used to balance the acid levels in the blood.

For example, dialysis drugs GranuFlo and NaturaLyte are linked to increased risk of heart attacks and strokes. Some patients suffered fatal heart attacks after using these drugs during treatment. Surviving loved ones and spouses filed lawsuits against the drugs' maker, Fresenius Medical.

Generally, there are two kinds of dialysis for kidney patients: hemodialysis (HD) and peritoneal dialysis (PD). Hemodialysis is by far the most popular and common treatment, and about 95 percent of all patients use this method.

Each type of treatment has its own set of possible complications.

Hemodialysis and Its Side Effects

Hemodialysis filters extra fluid, waste, toxins and helps keep the electrolytes in the blood balance. With proper training, patients can perform the procedure at home. Otherwise, they can go through treatment at a dialysis center. Most people choose the center.

During the process, blood travels out of the body through a tube, is passed to a dialyzer – a machine that functions like a kidney – and then returns to the body. Nurses or technicians calibrate the dialysis to remove a certain amount of fluid based on a patient's weight, retained fluid and body chemistry. They also add a dialysate, a drug that contains electrolytes, to balance the acidity of the blood. This solution is what actually pulls the waste from the blood.

Unfortunately, these drugs can create chemical imbalances in the body, and some of them can be fatal. Those include heart attacks, infections, low blood pressure and muscle cramps.

Heart Attacks

The most serious complication from hemodialysis is the increased risk of heart attack caused by GranuFlo and NaturaLyte. The unique formula of these dialysates increases levels of an electrolyte called bicarbonate in the blood. According to Fresenius' studies of patients in its own dialysis centers, these drugs caused more than 900 heart attacks in 2010. The drugs increased the risk as much as six times.

A year after learning these statistics, in November 2011, the company circulated an internal memo outlining them, warning its dialysis centers and health care workers. It did not warn other centers across the country, ones that also bought and used GranuFlo and NaturaLyte as ingredients in dialysis.

The FDA obtained a copy of the Fresenius memo and released a safety communication to those other treatment centers, warning the public about the risk of potentially fatal heart attacks and about the other side effects from the medications.

Common HD Side Effects

  • Low blood pressure. This is the most common side effect of hemodialysis. Low blood pressure can cause nausea and dizziness. When dialysis removes too much fluid, blood pressure drops.
  • Infection. Doctors create an access point in the body where the dialysis tubes will connect. Sometimes sleeping on this point or not keeping it clean can irritate it or cause an infection. Blood clots may also block the access point.
  • Muscle cramps. When fluid leaves the body too fast, this may also cause muscle cramps in the legs. These cramps may be mild or very painful.
  • Sexual side effects. Loss of sexual desire, erectile dysfunction and vaginal dryness are common during the dialysis treatment period.

Peritoneal Dialysis and Its Side Effects

Peritoneal dialysis (PD) is a more flexible treatment than hemodialysis because patients do not have to visit a treatment center. In fact, people can do the procedure at home or at work. During this procedure, patient or caregivers pump dialysate into the peritoneum, a membrane that lines the abdominal cavity. This fluid pulls the waste from the blood in the abdomen.

A cycler is a machine that pulls out old dialysate and replaces it with fresh dialysate, but patients can also do this manually during the day or at night. They must let the dialysate sit in their abdominal cavity for a small amount of time before it is drained and flushed.

Not everyone qualifies for PD. Patients must be able to adhere to a strict schedule, have a healthy peritoneum and manual dexterity. If they do qualify, they receive training about doing the PD and about how to spot infections at the dialysis site.

A study conducted by researchers from the National Kidney Foundation in 2011 showed that initial survival was better for people who chose PD, but over time risk of death becomes the same or greater compared with in-center HD.

Common PD Side Effects

PD has fewer side effects, fewer dietary restrictions and greater flexibility for treatment schedules than hemodialysis. Some complications can occur, including hernias, infection and bloating.

  • Infection. This is the most common side effects of PD. The access point where the catheter enters the abdomen can become infected if not kept clean. Anyone touching the catheter or the access point should wash their hands and use antibiotic washes.
  • Hernias. The catheter can weaken muscles in the abdominal wall and when the solution pushes into the weak wall, organs may protrude through the torn muscle.
  • Bloating and weight gain. When fluid sits in the abdomen, it can cause bloating. Sugar in the dialysis solution may also cause extra calories to be absorbed by the body.