Since the FDA announced recalls for Granuflo and Naturalyte, both dialysis medications, many lawsuits have been filed related to the damage these substances have caused. Both drugs are manufactured by Fresnius Medical Care and both have been found to cause serious health concerns, including fatal heart attacks. The FDA recall started March 29, 2012 and is a Class I recall, the most serious available to the FDA. Class I recalls mean that the medication has a reasonable chance of causing dangerous health complications.
During dialysis, a solution of ultrapure water, bicarbonate concentrate, and an acid concentrate are needed to facilitate the filtering process. Granuflo and Naturalyte are two of the solutions sold by Fresnius and were used in the company’s medical centers, responsible for treating nearly 150,000 patients in the nation. However, these solutions contain an elevated level of bicarbonate than competing products, which has resulted in many doctors administering dangerous doses of the medication. Many people who have received care at a Fresnius dialysis center have filed lawsuits asserting that the company did not explain the risks of the drug to their doctor well enough.
The FDA is also concerned that Fresnius did not adequately inform doctors and patients of the inherent risk of Granuflo and Naturalyte. On November 4, 2011, the company sent out an internal memo to all of its directors and physicians informing them that these drugs were responsible for elevated bicarbonate levels in many of their patients. However, these findings were never communicated to the public at large, nor were they communicated to physicians at other dialysis centers. Patients filing lawsuits against the company have asserted that this is negligence on the company’s part. The FDA is currently investigating the company to determine whether or not Fresnius was in violation of federal regulations. Several medical officers in charge of clinics that use Fresnius products are also unhappy with the company’s reluctance to inform them of the inherent risks of their medications. For these reasons, many dialysis patients filing lawsuits have received a favorable ruling.
The danger in Granuflo and Naturalyte comes from its high level of bicarbonate. Bicarbonate is needed while filtering blood, but too much of it can become a concern. Granuflo and Naturalyte both contain ingredients that the body eventually processes into bicarbonate, among other substances. This, coupled with the medication’s already high level of bicarbonate, means the body can quickly get overwhelmed by the substance. In large concentrations, bicarbonate will cause elevated pH levels in tissues throughout the body which may result in metabolic alkalosis. Its symptoms include slowed breathing, including apnea that can last for 10 to 20 seconds at a time. The skin may turn bluish and nausea, vomiting and diarrhea may be present. If not addressed right away, heart failure may occur.
While it is possible to administer Granuflo and Naturalyte safely, because they produce higher levels of bicarbonate than other products, it is difficult for doctors to dose and monitor them closely. This is another concern that dialysis patients filing lawsuits have enumerated in litigation against Fresnius.
Anyone who has taken these medications and suffered from serious health complications should consider speaking to drug injury attorneys experienced in the area. These legal professionals can represent a victim in court and may be able to help them attain restitution for their injuries.