FDA Recalls Granuflo Due to Increased Risk of Heart Attack

GranuFlo dialysis solution has come under scrutiny in 2012 due to an increased risk in causing sudden cardiac arrest among patients.  The Food and Drug Administration conducted a study of GranuFlo early in 2012, and issued a nationwide recall in June after the agency discovered the chance of fatal side effects.

What is GranuFlo?

Produced and sold by Fresenius Medical Care (FMC), GranuFlo is a dry powder that is commonly used on dialysis patients to help regulate their kidney function.  The medical details of dialysis can be quite complex, but generally the process stimulates kidney metabolism by passing through the kidney a solution comprised of highly purified water, and concentrated compounds that regulate critical kidney functions.  A compound known as bicarbonate is critical to dialysis treatment because it neutralizes the acid in the blood, and helps regulate the body.

Dialysis balances out acid levels by neutralizing the acid produced by the body by mixing alkaline in the form of bicarbonate into the blood.  Dialysis medications like GranuFlo are administered with bicarbonate to make sure the body can properly neutralize acid that builds up as a byproduct of normal metabolism.  However, too much alkaline could result in serious heart failure, so it is critical that the dialysis process uses the correct levels of bicarbonate so the body is properly regulated.  

The Risks of GranuFlo

In early 2012, a study revealed that the active ingredient in GranuFlo, unlike the active ingredient in other dialysis medication, actually converts into bicarbonate once it is administered.  This means that the bicarbonate levels in the body are too high when GranuFlo is used because the drug is administered with bicarbonate.  The sum of the bicarbonate that is added with the GranuFlo and the bicarbonate that GranuFlo’s active ingredient becomes is more than doctors intend to use in the dialysis process.  If the bicarbonate level administered during the dialysis process are too high, there can be serious heart problems because the body is not properly regulated.

Doctors who used GranuFlo for dialysis were unaware of the fact that the active ingredient converted to bicarbonate, and used it without knowing it resulted in higher levels of the compound within the body.  Because GranuFlo significantly increases the levels of bicarbonate added to blood during dialysis without the physicians’ knowledge, the product posed an unknown risk to patients. Doctors were not informed of GranuFlo’s nature, and the product was widely used in ignorance of its properties from 2008 – 2012.

GranuFlo was linked to increase risk of heart attack, stroke, and sudden cardiac death (SCD) amongst patients using the drug.  SCD occurs when patients without any known heart diseases suffer a sudden, and fatal, heart failure, and may be linked to as many as 25% of deaths amongst dialysis patients.

A Note on NaturaLyte

NaturaLyte, also produced by Fresenius Medical Care, is a liquid dialysis solution that was also recalled due to high levels of bicarbonate.  NaturaLyte does not present the same risks as GranuFlo because the bicarbonate levels are lower, but the product still has higher levels than existing liquids.  While most of the focus is on GranuFlo, a patient or family member of a patient who suffered heart failure after the use of NaturaLyte should contact an attorney immediately.

FDA Investigation of GranuFlo

The Food and Drug Administration began investigating GranuFlo dialysis solution to determine if the product created a significant risk of sudden cardiac death amongst dialysis patients with no history of heart problems.

In May of 2012, the FDA issued an official communication to physicians warning about GranuFlo’s higher levels of bicarbonate.  Many physicians were unintentionally adding too much bicarbonate because they did not know GranuFlo had higher levels than other drugs.  As a result, the dialysis process, designed to regulate the body, failed and the risk of heart failure increased.  The FDA’s official communication was designed to inform physicians of the potential problems with GranuFlo so they could adjust their dialysis process accordingly.

In June of 2012, the FDA issued a Class 1 product recall for Fresenius Medical Care’s GranuFlo kidney dialysis drug.  A Class 1 product recall is issued when there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.  The FDA noted the risks of sudden cardiac failure associated with GranuFlo, and took action to take the product off the market.

This action by the FDA indicates that GranuFlo dialysis solution poses a serious risk to the patients who use it, and that the drug can be a major contributor to sudden cardiac death.  If you are a dialysis patient, or knows someone who is, be aware of the risks of GranuFlo and take action in accordance with the product recall.

Granfulo, manufactured by Fresenius Medical Care, has been recalled by the FDA and should not be used on any dialysis patient.  In the aftermath of the recall, and the deaths caused by the use of GranuFlo, expect legal action against Fresenius Medical Care seeking compensation for patients injured or killed by use of the GranuFlo solution.

To understand the basis for a lawsuit against the makers of GranuFlo, click here.

To track progress of litigation against GranuFlo, click here.

If you would like to find an attorney in your area who can assist you with a claim based on the use of GranuFlo, click here.

Case Studies: Insurance Implications of FDA Recall for GranuFlo and Increased Risk of Heart Attack

Case Study 1: Product Liability Insurance for Medical Manufacturers

In the case of the FDA recall for GranuFlo due to the increased risk of heart attack, product liability insurance becomes essential for the manufacturer, Fresenius Medical Care. Product liability insurance provides coverage for claims or lawsuits alleging harm caused by defective products.

In this scenario, GranuFlo, a dialysis solution manufactured by Fresenius, was found to have higher levels of bicarbonate, leading to an increased risk of heart failure among dialysis patients.

Product liability insurance would help protect the manufacturer by covering legal defense costs, settlements, or judgments related to the recall and any resulting claims, ensuring financial stability and protecting the company’s reputation.

Case Study 2: Professional Liability Insurance for Medical Professionals

Medical professionals, including physicians and healthcare providers involved in administering GranuFlo to dialysis patients, may need professional liability insurance, also known as malpractice insurance. Professional liability insurance provides coverage for claims arising from professional negligence or errors in healthcare.

In this case study, if medical professionals were unaware of the risks associated with GranuFlo and continued to use it without adjusting the dialysis process, they may face allegations of negligence.

Professional liability insurance would help cover legal defense costs, settlements, or judgments in malpractice claims, providing financial protection for the professionals involved.

Case Study 3: Product Recall Insurance for Manufacturers and Distributors

For manufacturers and distributors involved in the production and distribution of GranuFlo, product recall insurance is crucial. Product recall insurance provides coverage for the costs associated with recalling and replacing a defective product.

In this scenario, the FDA issued a Class 1 product recall for GranuFlo due to the increased risk of heart attack. Product recall insurance would cover expenses such as notifying customers, shipping and disposal of recalled products, and potentially even business interruption losses.

Having this insurance coverage would help mitigate the financial impact of the recall and ensure the manufacturer and distributor can handle the costs involved.