In a classic case of the pot calling the kettle black, the FDA is accusing Fresenius Medical Center of failing to warn customers of a product’s cardiac arrest risk, according to the New York Times. Just last week, we posted a story about the FDA failing to notify people of dangerous drug recalls, but the FDA is now accusing Fresenius of not telling consumers about the lethal risk of GranuFlo, one of the company’s products currently being used for dialysis treatment. The Times reports that the company’s first warning was actually an internal memo sent to its dialysis centers in November of 2011 telling doctors that improperly using GranuFlo could result in patients’ possible cardiac arrest and death.
Fresenius Medical Care’s website states that it is the world’s leading company in renal care and an important part of the lives of nearly 138,000 patients who receive dialysis treatment from over 1,800 Fresenius clinics in the U.S. That doesn’t even include the estimated 125,000 patients who are treated with GranuFlo outside of Fresenius clinics. These clinics never received the internal memo. In March, the FDA received a copy and contacted Fresenius to ask questions.
What the FDA learned in the memo hyperlinked in the Times' story was that 941 patients treated with GranuFlo inside Fresenius clinics suffered from cardiac arrest in 2010. GranuFlo is different compared to other products used for dialysis in that it contains an ingredient that raises the level of bicarbonate in the body, which is used to neutralize acid buildup in the blood. GranuFlo can cause an overdose of bicarbonate in the blood which increases the risk of cardiac arrest. After the FDA contacted Fresenius, the company notified its customers in late March. In May, the FDA issued a warning concerning all products associated with GranuFlo.
The FDA is still furious at the fact that Fresenius didn’t even bother to bring this matter to light outside of its own company. The company’s chief medical officer in North America, Franklin W. Maddux, told the New York Times that his company had no way of communicating with non-company clinics about this issue. According to Maddux, the only way his office could’ve communicated was through medical journals since the findings in the memo didn’t warrant a publication due to them being too preliminary. If that was the case, then perhaps a phone call would’ve helped.