GranuFlo is an acid concentrate used during dialysis treatment that can have deadly consequences for patients. Consult our experienced attorneys if you or a loved one has been harmed by GranuFlo.
The popular dialysis product, GranuFlo, has been subjected to a Class I recall by the FDA, which means the agency believes the drug may cause serious adverse health consequences, including death. GranuFlo is manufactured by a German company called Fresenius Medical Care (FMC), which owns and operates about one-third of all dialysis clinics in the United States, and supplies dialysis products to many clinics worldwide. GranuFlo and other products of its kind are used in dialysis clinics because they can help rid the body of toxins that typically build up during the dialysis process. Unfortunately, serious concerns have been raised about the safety of GranuFlo, due to its potential link to severe side effects like cardiac arrest, heart attack, stroke and death. If you have experienced a serious side effect, and you believe FMC’s GranuFlo to be the cause, contact our experienced attorneys at Oklahoma Legal Center today. Our lawyers can inform you of your legal options and help you file a claim for compensation.
Uses of GranuFlo
During dialysis, toxic wastes are removed from the body in patients whose kidneys aren’t functioning properly due to kidney failure. GranuFlo is an acid concentrate that consists of both acetic acid – like other dialysis products – and sodium acetate, which the body converts into bicarbonate, a natural salt that that helps alkalize the blood and rid the body of toxins. Fresenius Medical Care introduced GranuFlo in 2003, and has since marketed the drug as superior to other dialysis products, given its ability to more easily be converted into bicarbonate by the body. Unfortunately, new information suggests that GranuFlo may actually lead to an elevated level of bicarbonate, which creates a pH imbalance called metabolic alkalosis. According to the FDA, metabolic alkalosis is an independent risk factor for major side effects like sudden cardiac death, low blood pressure, low blood oxygen, high blood carbon dioxide and heart rhythm problems.
GranuFlo and Possible Side Effects
Despite FMC’s claims that “GranuFlo’s distinctive proportional component blend in each bag” makes it “the safest choice for on-site concentrate mixing,” the GranuFlo recall issued by the FDA and an internal memo issued by FMC itself suggest otherwise. In November 2011, FMC delivered an internal memo to doctors in its own clinics, warning that as many as 941 GranuFlo patients had suffered sudden cardiac arrest due to improper administration of the drug. Apparently, the rate at which GranuFlo converts to bicarbonate in the body requires doctors to closely monitor patients’ doses to avoid the risk of sudden cardiac death during or shortly after dialysis treatment. Other possible GranuFlo side effects include:
- Heart attack
- Cardiac arrest
- Altered mental status
- Low blood pressure
Unfortunately, FMC chose to conceal the critical information included in the memo from non-FMC clinics, putting more than 100,000 GranuFlo patients at an unnecessary risk of potentially deadly side effects. It wasn’t until March 2012 that the FDA received the memo from an anonymous source and issued a warning to the public, followed by a Class I recall of GranuFlo.
Contact Our Attorneys to File a Claim
If you took GranuFlo and have since suffered from a major side effect, contact our qualified lawyers at Oklahoma Legal Center to discuss your options for legal recourse. You may have grounds to file a defective drug lawsuit against FMC, in order to pursue compensation for your injuries, medical bills, lost wages due to missed time at work, and other damages. If you lost a loved one to complications related to GranuFlo, you may be entitled to reimbursement for funeral and burial costs, which you can pursue by filing a wrongful death lawsuit against the company. Attorneys across the country are investigating claims associated with GranuFlo, and several wrongful death lawsuits have already been filed against Fresenius Medical Care for GranuFlo-related complications. With the help of our knowledgeable attorneys at Oklahoma Legal Center, you can protect your legal rights and seek fair and timely reimbursement for your injuries.