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Dangerous Discovery: FDA Recall of Dialysis Drugs Granuflo, Naturalyte

Posted on Oct 22, 2012

Photo of Hospital Emergency Room ExteriorThe dialysis drugs Granuflo and Naturalyte have been recalled by the FDA for their concentration of either acetate or sodium diacetate, which can lead patients to have an unsafe spike of high bicarbonate levels, a condition known as metabolic alkalosis. The pharmaceutical attorneys of Hupy and Abraham in Milwaukee, Wisconsin, and Illinois are now taking cases relating to these drugs and anyone affected by them.

Fresenius Medical Care has three centers in the Milwaukee area (Brewer’s Hill, Shorewood, West Allis) as well Gurnee, Waukegan and Antioch in Illinois.

Granuflo, Naturalyte: Recall, Side Effects

Distributed from January 2008 to June 2012 by Fresenius Medical Care (FMC), the largest operator of dialysis centers in America, the dry and liquid acid concentrate products have a Class I Recall, the most serious type for products that have reasonable probability to cause serious adverse health consequences or death.

Granuflo (dry) and Naturalyte (liquid) is used for the treatment of acute and chronic renal failure and has been found to cause metabolic alkalosis, which can cause:

  • low blood pressure
  • heart attack
  • cardiac arrest
  • hypokalemia (decrease of potassium in the blood)
  • hypoxemia (decrease of oxygen in the blood)
  • hypercapnia (increase of carbon dioxide in the blood)
  • cardiac arrhythmia (irregular heartbeat)
  • death

These side effects tend to take place quickly, typically within 5-10 days, so feeling symptoms following a treatment are not unusual.

About the Dangerous Discovery by Fresenius Medical Care

In November 2011, Germany-based FMC sent out a memo to their facilities that warned their physicians about Granuflo and Naturalyte, failing to alert external facilities that were also using their products.

The FDA became aware of this memo and contacted FMC about these concerns in March 2012. According to RenalWeb, “[o]nly then did FMC provide a scientifically-ambiguous, 2-page memo with far less actionable information to its non-FMC customers” two days later

According to the New York Times, the FDA is now investigating if the company “violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products.”

Contact Hupy and Abraham Today

If you or someone you know has taken Granuflo or Naturalyte at some point and may or have suffered any of the listed conditions, contact the medical personal injury lawyers of Hupy and Abraham for a free, confidential, no-obligation consultation. Remember, side effects can take place within one week, so do not hesitate to call our attorneys today to get started on your case, toll-free at 800-800-5678.