Patients undergoing kidney dialysis should not have to wonder whether the medications they are receiving are safe. But an FDA investigation of one of the largest operators of dialysis centers and a major supplier of dialysis products raises serious safety concerns.
This year, the FDA issued a Class I recall of dialysis drugs Granuflo and NaturaLyte acid concentrate manufactured by Fresenius Medical Care North America. Class I recalls are the most serious type of product recall. They involve situations in which there is a reasonable probability that the use of the products will cause serious injury or death.
Dialysis performs the function of the kidneys in removing toxins from the bloodstream. Fresenius, a health care company, is the largest operator of kidney dialysis treatment centers in the United States and supplies medical products used by other dialysis centers. Earlier this year, Fresenius issued an urgent product notification regarding its NaturaLyte liquid and Granuflo powder products, which contain acetate.
The body converts acetate to bicarbonate, which neutralizes the acid that builds up in the blood. But dosing errors can cause elevated levels of bicarbonate. According to Nephrology News and Issues, borderline elevated pre-dialysis bicarbonate levels are associated with six- to eight-fold greater risk of cardiac arrest and death in dialysis patients.
In November 2011, Fresenius’s medical office sent an internal memo to doctors practicing at the company’s dialysis clinics warning them that failure to use Granuflo properly appeared to be contributing to a notable increase in the risk of dialysis patients dying suddenly of cardiac arrest.
But Fresenius did not share the information with other dialysis centers that used its product, until earlier this year after the FDA obtained the internal memo and questioned the company about it.
According to The New York Times, the FDA opened an investigation into whether Fresenius Medical Care had violated federal regulations by failing to warn customers months earlier of potentially deadly risks associated with its product.
If you or a loved one suffered a heart attack during or after undergoing kidney dialysis, you should talk to an experienced lawyer about the specifics. The medical product attorneys at The Driscoll Firm, LLC, can determine whether an unsafe kidney dialysis product has harmed you or your family member.
The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by unsafe medical products and manufacturers that put profits ahead of safety. We have helped thousands of clients nationwide receive full and fair compensation from medical product manufacturers whose products cause harm. If you suspect that you or a loved one has been harmed by an unsafe drug, contact us at 314-932-3232 or use our online contact form for a free case review.