In a latest development FDA issues Class 1 Recall for the well-known dialysis drug GranuFlo. It is important to underline here that Class 1 Recalls are generally issued to those drugs and medical devices that are defective and unsafe in some point in time. These dangerous and unsafe drugs could have adverse impact on the human body or can lead to even death. Some of the products that come into this category include foods that contain allergens, life saving drugs that have a label mix-up, implants that are defective or food stuffs that are contaminated.

GranuFlo® and NaturaLyte® sold by the company are acid concentrates that are diluted to become a component of dialysate that acts as the blood purifier and is used to clean the blood of patients undergoing hemodialysis for treatment of renal (kidney) failure.

It is important to note here that NaturaLyte and GranuFlo are not inherently dangerous products, but become lethal when errors occur in their mixing and administering.

Generally other acid concentrate products consist primarily of acetic acid, but GranuFlo is the only combination that contains acetic acid plus sodium acetate, (sodium di-acetate). Sodium acetate gets converted into bicarbonate by the patient’s tissues/liver, effectively increasing bicarbonate levels beyond what was initially prescribed. This increased level of bicarbonates results into some increased risk of metabolic alkalosis which is one of the common dangers with GranuFlo.

GranuFlo and NaturaLyte are manufactured by Fresenius Medical Care (FMC) aGermanybased medical device company. It is one of the largest dialysis clinic operators in the world. Reports from various sources say that in early days of 2011 the company issued an internal notice to its own clinics giving a clear cut indication of associated side effects of the drug. However, the manufacturer failed to offer the same warnings to thousands of physicians that are working on clinics that are not owned by the manufacturer.

Hence if you or a loved one of you is using GranuFlo ensure that the concerned physician is properly formulating the dialysate at the clinic.

A high level of bicarbonate levels caused by GranuFlo® can cause a wide range of health related problems for dialysis patients for up to two years following use. Some of the side effects are:

  • Heart problems
  • Cardiopulmonary arrest
  • Heart problems
  • Low blood pressure
  • Metabolic alkalosis
  • Cardiac arrhythmia
  • Sudden heart attack
  • Stroke
  • Death

However, if you use and prescribe Granuflo® combination for patients as a physician or clinic ensure below mentioned things:

  • Clinics or physicians should know that alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) is linked to high death rate in patients who are under dialysis.
  • Physicians need to understand in advance how  specific hemodialysis device proportions (mixes) the acid and base concentrates
  • Prior to prescribing physicians need to have a detailed review of the dialysate acid concentrate labeling for the specific concentrate or determine the components that can contribute to the patient’s bicarbonate level.
  • Physicians or clinics need to know that the levels of acetic acid, acetate, and citrate tend to vary with manufacturer and products.