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GranuFlo Side Effects Lead to Lawsuits


 

If you were given GranuFlo or NaturaLyte during a dialysis treatment you underwent prior to the recall issued in June 2012 by the U.S. Food and Drug Administration (FDA), you may have experienced life-threatening GranuFlo side effects. These side effects, which occur within 48 hours after the drug is administered, may include serious cardiac injuries and even death.

GranuFlo Side Effects Lead to Lawsuits

Lawsuits are now being brought on behalf of patients who were treated with GranuFlo or NaturaLyte and experienced the following GranuFlo injuries:

  • cardiovascular death
  • sudden cardiac death
  • cardiopulmonary arrest
  • heart attack
  • other catastrophic heart injuries

granuflo side effectsGranuFlo and NaturaLyte are acid concentrates used to neutralize acid-build up that occurs during dialysis treatments. Although GranuFlo is an acid concentrate powder and NaturaLyte is a liquid, both drugs contain an ingredient the body converts to bicarbonate, which is common to competing rival dialysis drugs. However, GranuFlo and NaturaLyte contain more of this ingredient, which may heighten the patient’s risk for alkalosis. This condition is associated with an increase in cardiovascular death, heart attacks, and other catastrophic GranuFlo injuries.

A frightening characteristic of GranuFlo side effects is that drug maker, Fresenius USA, is the largest dialysis services and products company in the U.S. and around the world, operating over 125,000 dialysis clinics. The company also operates more than 1,800 kidney dialysis clinics in the U.S. alone. Its products are also used by thousands of independent clinics in the U.S.

In June 2012, the same month the U.S. Food and Drug Administration (FDA) issued its recall prompted by GranuFlo side effects, the agency anonymously received a copy of an internal memo sent by Fresenius USA from several months earlier. The agency learned that in November 2011, officials from Fresenius sent a letter to doctors operating in its dialysis centers, warning them that improper use of GranuFlo and NaturaLyte may lead to cardiac injury-induced sudden deaths in patients undergoing dialysis treatments.

The letter was drafted by Fresenius after the company was made aware of a high rate of cardiac arrests that had occurred in its dialysis centers during 2010. The GranuFlo recall was then categorized as Class I by the FDA, which is the most serious type of recall only issued when there is a high likelihood that a product could lead to serious side effects and/or death.

As of January, more than 30 GranuFlo lawsuits alleging the manufacturer failed to warn consumers of the risks associated with the dialysis drugs were pending in U.S. federal court. Fresenius USA has voiced its support for the formation of a multidistrict litigation in Massachusetts federal court where the company is headquartered, to handle pre-trial proceedings.