Heart attack risks linked to kidney dialysis drug GranuFlo
Last year, the Federal Drug Administration issued a Class I recall notice for GranuFlo and NaturaLyte Dry Acid Concentrates. A spike in the sudden cardiac arrests and deaths of dialysis patients across the country and in Pennsylvania necessitated the
drug recall.
The drugs are used to treat acute and chronic kidney failure. When a patient's kidney function falls to 10 to 15 percent, hemodialysis is required. In dialysis, a machine filters wastes, salts and fluids from the blood because the patient's kidneys can no longer do this work. Some of the most common causes of kidney failure are:
- Diabetes
- Polycystic kidney disease (cysts in a patient's kidneys)
- High blood pressure (hypertension)
Fresnius Medical Care, the manufacturer of the drugs is the largest operator of U.S. dialysis centers. Estimates are that it provides dialysis treatment to approximately 400,000 patients each year. Complications and side effects can occur during treatment, but should not include heart problems.
What does a Class I recall mean?
A Class I
drug recall is the most serious. The FDA issues this type of recall when a "reasonable probability exists that a product will cause serious adverse health consequences or death." In the case of GranuFlo, concerns exist regarding dosing. Depending on the dosage, GranuFlo and NaturaLyte can cause alkalosis (an abnormal acid/base concentration in the blood), which may ultimately lead to death or serious heart injuries.
Timing of warnings
Fresnius allegedly warned its own clinics about the dangers in November 2011. This was after more than 900 patients suffered cardiac arrest in their clinics during 2010. Patients with higher levels of bicarbonate in their blood had a much higher risk of a heart attack. The wider recall was not issued until March 2012.
Duty to warn
Pharmaceutical companies must adequately label their prescription drugs and warn of potential dangers. When there are adverse reactions, these companies have a duty to immediately warn physicians and patients. A lack of adequate warning or delay in proving a widespread warning can result in serious injuries and wrongful deaths. Before a drug makes it to the marketplace, clinical trials test for dangerous side effects. Sometimes a drug makes it through the trials, but it is not until later that a manufacturer fully appreciates the dangers. For that reason, FDA recalls need to be made as soon as a manufacturer learns of the danger. It appears that Fresnius did not issue a recall notice immediately upon learning of dangers. If you or a loved one suffered a heart attack or serious injury while receiving dialysis treatment, contact a drug recall attorney to discuss your case. There may be remedies available. Holding a company accountable ensures that others do not suffer similar injuries.