Leaked Internal Memo Warns of GranuFlo Side Effect Risk
When Fresenius Medical Care (FMC) discovered in November 2011 that its widely used dialysis concentrate, GranuFlo, had the potential to cause life-threatening side effects in patients – including sudden cardiac arrest – if the dosage was not properly adjusted, the company issued an urgent internal memo warning doctors at its own clinics about this side effect risk. As urgent as the situation was, however, FMC failed to issue the same warning to the many on-site dialysis providers and medical clinics that were not run by Fresenius, but that also used GranuFlo, notifying them that as many as 941 patients suffered fatal cardiac arrest in 2010 alone after being given GranuFlo during dialysis. If you have experienced a heart attack or another serious side effect, and you believe GranuFlo to be the cause, contact our reputable attorneys at AMA Law today. Our lawyers have experience litigating drug injury cases, and can help you pursue the financial compensation you deserve.
GRANUFLO RECALLED BY FDA OFFICIALS
FMC’s inexplicable failure to send the same memo to doctors at non-FMC clinics as to its own doctors allowed patients receiving dialysis treatment from outside providers to remain at risk of potentially fatal side effects associated with GranuFlo. It wasn’t until March 2012 – four months later – that the U.S. Food and Drug Administration (FDA) received a copy of the internal memo from an anonymous source and questioned FMC as to why the company had not circulated the warning to all clinics using GranuFlo. During the FDA’s investigation of FMC’s actions, the dialysis provider finally sent out a side effect warning regarding GranuFlo to its entire customer base. This action was followed by a public safety alert issued by the FDA in Mary 2012, and then a Class I GranuFlo recall in June 2012.
CONTACT OUR ATTORNEYS FOR ALLEGED GRANUFLO COMPLICATIONS
The potentially harmful aspect of GranuFlo lies in the fact that the dialysis product has the potential to raise bicarbonate levels more than other acid concentrates. Since doctors administering GranuFlo were not aware of this issue, they were not adjusting the dosages properly, and the result was elevated bicarbonate levels in their patients’ blood. This, in turn, can lead to a condition called metabolic alkalosis, which is a major risk factor for complications like stroke, arrhythmia, heart attack and other life-threatening side effects. In fact, in its internal memo, FMC noted that the 941 GranuFlo patients who experienced fatal complications in 2010 were found to have elevated levels of bicarbonate in their blood. If you received GranuFlo treatment during dialysis and you have since suffered a serious side effect, or if you lost a loved one to dialysis complications potentially related to GranuFlo, consult our knowledgeable lawyers at AMA Law to explore your compensation options.