Delayed Drug Recall Threatens Patient Safety

The time allowed by law in which you may file a lawsuit is limited. If you wait to contact an attorney, you may end up being barred by the statute of limitations from proceeding.

Due to serious side effects caused by NaturaLyte and GranuFlo, the US Food and Drug Administration has issued Class 1 drug recalls on these dialysis products. These pharmaceuticals can be potentially harmful. They are acid concentrates which are diluted and are then used in a dialysate that detoxifies the  patient’s blood. It is used to treat patients who have renal kidney failure and are undergoing hemodialysis. If the dialysate has incorrect proportions of its respective components due to human error, it can make these patients vulnerable to bicarbonate overdosing.

GranuFlo and NaturaLyte are both ingredients in the final dialysis solution and are used as a dry concentrate and liquid concentrate respectively. In order to replicate the patients’ kidney function and purify their blood, the solution is mixed with clean water and sodium bicarbonate is added to the solution.

The potential overdosing which led to the drug recalls was due to the unique composition of GranuFlo and NaturaLyte as compared to other acid concentrates. While the latter are majorly made of acetic acid, the other two also contain sodium acetate or sodium di-acetate in addition to acetic acid. This sodium acetate is converted by the patients’ liver or tissues into bicarbonate which increases the bicarbonate level in the body to a dangerous point, beyond what is normally prescribed.

Thus, the ideal levels of bicarbonate and acid are absolutely vital for the human body. An incorrect mixture of dialysate can result in high bicarbonate levels which can make a patient prone to metabolic alkalosis which is a harmful side effect caused by GranuFlo.

However, it must be noted that both NaturaLyte and GranuFlo are not dangerous products inherently but become such when they are mixed and administered in a negligent and careless fashion.

The company that announced the drug recalls is also the maker of products and machines which are employed during dialysis treatments and is called Fresenius Medical Care manufacturers. It is also amongst the largest clinic operators for dialysis in the world. During 2011, the company distributed an internal memo to its company-owned clinics in which it notified them about the potential side effects and risks associated with the products. However, they ignored the other clinics and scores of physicians who prescribed these drugs were unaware of their hazards.

However, when the note was received by the Food and Drug Administration in 2012, the FDA asked for a drug recall for both NaturaLyte and GranuFlo products. The company was held responsible for at least 941 episodes of fatal heart failure and cardiac arrest in hemodialysis patients. The whole matter was kept within the confines of the company until a Fresenius employee secretly leaked the note to the FDA. Subsequently, a Class 1 recall was issued which is reserved for medical products which can possibly result in serious injuries or even wrongful deaths.

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The time allowed by law in which you may file a lawsuit is limited. If you wait to contact an attorney, you may end up being barred by the statute of limitations from proceeding.

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