Granuflo is a drug manufactured by Fresenius Medical Care, and is primarily used on patients during dialysis treatments. Its purpose is to lower the pH level of fluids in the body through bicarbonate diffusion. This drug has been extremely popular for use on dialysis patients in recent years, but new information confirms that it significantly increases the likelihood of several potentially deadly cardiovascular complications.
Anyone who has received this medication and has experienced any severe cardiovascular issues should contact a drug injury lawyer for help. A knowledgeable personal injury attorney will be valuable when it’s time to put together a case for recompense. Mass tort occurs when a party commits a wrongdoing that harms many people, and it is difficult for someone without professional help to handle on his or her own.
Fresenius handles treatment for more than 100,000 American dialysis patients currently, and in addition to this medication, it also manufactures and maintains dialysis machines and produces other products used in various clinics. So far, Granuflo and NaturaLyte, another dialysis drug, have both been investigated by the Food and Drug Administration. What they found is that regular use of these substances can cause fatal cardiac arrest, heart attack, cardiopulmonary arrest or a number of other circulatory-related issues. This isn’t the only troubling thing the FDA uprooted, however.
An internal memo circulated within Fresenius reveals that the company was aware of the health issues resulting from the drug several months before they sent notification to the clinics. The March 29, 2012 release sent to clinics indicated an “urgent product notification” that went into specifics regarding risk factors associated with usage of NaturaLyte and Granuflo. In short, though the bicarbonate is essential in removing excess metabolic acids from the blood, and too much of it can cause a condition known as alkalosis. Alkalosis results from an excess of base material in the body’s tissues, which lowers the pH of the bodily fluids. It has been found that alkalosis can, with time, increase the risk of cardiac complications by six to eight times.
Granuflo is particularly troublesome, because it contains acetate on top of a dose of bicarbonate. Acetate is broken down into bicarbonate by the body, meaning that a patient would receive a larger dose of the substance than was intended once administered. In addition, the drug contains more bicarbonate than competing substances. Communication sent out by Fresenius states that doctors should be able to calibrate the dosage to circumvent these issues, but the FDA is now investigating if Fresenius acted irresponsibly when choosing to delay public announcement of their product notification.
Steven Silverman, director of compliance for the medical devices division within the FDA has stated that Fresenius should have notified patients of the risks associated with the product. Some estimates put the number of non-Fresenius clinic users of Granuflo at around 125,000. While no patient should cease taking dialysis medication outright, it is highly recommended that anyone currently on the drug should seek advice from both his or her doctor and a reputable attorney.