Fresenius
Medical Care, the largest supplier of dialysis equipment, products and services
in the world, released the dialysates, GranuFlo and NaturaLyte in 2003. They
used the products in the more than 1800 Fresenius clinics in the U.S. and
actively marketed the drugs to non-owned clinics. There is mounting evidence
that these drugs increase the risk of Granuflo heart attack or cardiopulmonary
arrest during dialysis 6 to 7 times compared to other dialysates.
Hemodialysis is a medical treatment for patients with acute renal (kidney) failure. A dialysis machine removes the blood from the body which is cleansed of waste with the aid of dialysates and returned to the body. The treatment typically takes three to four hours and is performed three times per week. The incidence of renal failure in the United States is approximately 2 in 1000 people. A total of about 400,000 patients undergo hemodialysis each year.
Dialysates are mixed with a bicarbonate buffer to reduce acid levels in the blood and maintain a normal pH balance in the body. NaturaLyte and GranuFlo, unlike other dialysates, contain active ingredients that include acetate and sodium acetate. Acetate and sodium acetate are converted to bicarbonate in the liver at a more rapid rate than the compounds used in other dialysates and when combined with the bicarbonate buffers, these drugs can cause a bicarbonate overdose.
When too much bicarbonate accumulates in the blood, a condition called metabolic alkalosis occurs. Metabolic alkalosis is a serious medical condition that can have life threatening complications including low blood pressure cardiac arrhythmia, cardiopulmonary arrest, hypokalemia (low serum potassium), hypoxia (low oxygen), hypercapnia (elevated carbon dioxide levels) and death. Patients suffering from metabolic alkalosis must have urgent medical intervention to avoid these serious problems.
Symptoms of metabolic alkalosis include:
Hemodialysis is a medical treatment for patients with acute renal (kidney) failure. A dialysis machine removes the blood from the body which is cleansed of waste with the aid of dialysates and returned to the body. The treatment typically takes three to four hours and is performed three times per week. The incidence of renal failure in the United States is approximately 2 in 1000 people. A total of about 400,000 patients undergo hemodialysis each year.
Dialysates are mixed with a bicarbonate buffer to reduce acid levels in the blood and maintain a normal pH balance in the body. NaturaLyte and GranuFlo, unlike other dialysates, contain active ingredients that include acetate and sodium acetate. Acetate and sodium acetate are converted to bicarbonate in the liver at a more rapid rate than the compounds used in other dialysates and when combined with the bicarbonate buffers, these drugs can cause a bicarbonate overdose.
When too much bicarbonate accumulates in the blood, a condition called metabolic alkalosis occurs. Metabolic alkalosis is a serious medical condition that can have life threatening complications including low blood pressure cardiac arrhythmia, cardiopulmonary arrest, hypokalemia (low serum potassium), hypoxia (low oxygen), hypercapnia (elevated carbon dioxide levels) and death. Patients suffering from metabolic alkalosis must have urgent medical intervention to avoid these serious problems.
Symptoms of metabolic alkalosis include:
·
Tingling or numbness of the
hands, feet and face
·
Cyanosis (bluish tint to skin)
·
Light-headedness and mental
confusion
·
Nausea, vomiting and diarrhea
·
Muscle twitching
High serum bicarbonate levels significantly increase the risk of
heart attack and cardiopulmonary arrest.
Internal Fresenius Internal Memo Disregards Safety of Thousands of Patients
In 2011, Fresenius conducted a review of 667 of their clinics and discovered that at least 941 patients had died of Granuflo heart attacks or cardiopulmonary arrest during dialysis treatments with GranuFlo and NaturaLyte. In November of 2011, they sent a notification to medical professionals in their clinics that warned of the risks of bicarbonate overdose and outlined proper protocols and dosage recommendations for the drugs.
Although FMC supplied hundreds of outside clinics with the dialysates, they took no action to notify healthcare professionals in these clinics of the risks or new protocols and dosage recommendations. At least half of all dialysis patients in the U.S. were treated with GranuFlo or NaturaLyte including about 125,000 treated at clinics not owned by FMC. The failure of Fresenius to notify the FDA, medical professionals and consumers of the dangers placed these patients’ lives at serious risk.
FMC and the FDA
Some evidence indicates that FMC may have been aware of at least some of the increased risk caused by their dialysates at the time the drugs were released. A 2010 FDA warning noted that they did not have a proper system to handle patient and physician complaints about the drugs, a violation of FDA regulations.
IN March of 2012, an unnamed source provided the FDA with a copy of the 6 page internal memo sent to Fresenius clinics in November 2011. The FDA sent an inquiry to FMC on March 27, 2012. The company responded by sending out a 2 page Urgent Product Notification to non-owned clinics using GranuFlo and NaturaLyte.
The FDA issued a Class I recall for NaturaLyte and GranuFlo manufactured after January of 2008 on March 29, 2012. A Class I recall is one of the strongest actions the FDA can take and it is only issued for products that present the possibility of serious adverse health reactions including death. Although the products were allowed to remain on the market, Fresenius was required to change the drugs' labeling to include proper warnings, medical protocols and dosage recommendations.
A Safety Communication was issued by the FDA on May 25, 2012 that advised healthcare professionals of the risks of GranuFlo and NaturaLyte, the need for monitoring bicarbonate levels in dialysis patients receiving the drugs and the importance of adjusting dosages regularly. Doctors were also advised that the bicarbonate levels in dialysates vary by both product and manufacturer.
The NY Times reported that FDA officials are investigating to determine if Fresenius broke federal laws by their failure to notify the FDA as soon as they knew of the potential problems with GranuFlo and NaturaLyte. The company could be forced to pay fines or other penalties if the FDA investigation finds they broke federal food and drug regulations.
GranuFlo and NaturaLyte Lawsuits
There are over 150 lawsuits against Fresenius pending in U.S. Federal District Courts for injuries suffered by patients who were administered GranuFlo and NaturaLyte during dialysis treatments. The lawsuits allege that the company aggressively marketed the drugs after they were aware of the risks and failed to provide adequate warnings to medical professionals and consumers.
GranuFlo lawsuits have been consolidated in a multidistrict litigation (MDL) to streamline the legal process and expedite trial dates. Fresenius continues to claim that the lawsuits are without merit and has not entered into settlement negotiations at this time.
A wrongful death lawsuit was filed in Alabama by Betty Lemmond whose husband, Dizzy Dean Lemmond died of a Granuflo heart attack after receiving dialysis treatments with the drug for about 2 months. Another wrongful death suit was filed by Waddell Bishop whose mother died of a heart attack after dialysis treatments. Many of the pending GranuFlo lawsuits are for wrongful death or serious disabilities and additional lawsuits are expected to be filed in the coming months.
Internal Fresenius Internal Memo Disregards Safety of Thousands of Patients
In 2011, Fresenius conducted a review of 667 of their clinics and discovered that at least 941 patients had died of Granuflo heart attacks or cardiopulmonary arrest during dialysis treatments with GranuFlo and NaturaLyte. In November of 2011, they sent a notification to medical professionals in their clinics that warned of the risks of bicarbonate overdose and outlined proper protocols and dosage recommendations for the drugs.
Although FMC supplied hundreds of outside clinics with the dialysates, they took no action to notify healthcare professionals in these clinics of the risks or new protocols and dosage recommendations. At least half of all dialysis patients in the U.S. were treated with GranuFlo or NaturaLyte including about 125,000 treated at clinics not owned by FMC. The failure of Fresenius to notify the FDA, medical professionals and consumers of the dangers placed these patients’ lives at serious risk.
FMC and the FDA
Some evidence indicates that FMC may have been aware of at least some of the increased risk caused by their dialysates at the time the drugs were released. A 2010 FDA warning noted that they did not have a proper system to handle patient and physician complaints about the drugs, a violation of FDA regulations.
IN March of 2012, an unnamed source provided the FDA with a copy of the 6 page internal memo sent to Fresenius clinics in November 2011. The FDA sent an inquiry to FMC on March 27, 2012. The company responded by sending out a 2 page Urgent Product Notification to non-owned clinics using GranuFlo and NaturaLyte.
The FDA issued a Class I recall for NaturaLyte and GranuFlo manufactured after January of 2008 on March 29, 2012. A Class I recall is one of the strongest actions the FDA can take and it is only issued for products that present the possibility of serious adverse health reactions including death. Although the products were allowed to remain on the market, Fresenius was required to change the drugs' labeling to include proper warnings, medical protocols and dosage recommendations.
A Safety Communication was issued by the FDA on May 25, 2012 that advised healthcare professionals of the risks of GranuFlo and NaturaLyte, the need for monitoring bicarbonate levels in dialysis patients receiving the drugs and the importance of adjusting dosages regularly. Doctors were also advised that the bicarbonate levels in dialysates vary by both product and manufacturer.
The NY Times reported that FDA officials are investigating to determine if Fresenius broke federal laws by their failure to notify the FDA as soon as they knew of the potential problems with GranuFlo and NaturaLyte. The company could be forced to pay fines or other penalties if the FDA investigation finds they broke federal food and drug regulations.
GranuFlo and NaturaLyte Lawsuits
There are over 150 lawsuits against Fresenius pending in U.S. Federal District Courts for injuries suffered by patients who were administered GranuFlo and NaturaLyte during dialysis treatments. The lawsuits allege that the company aggressively marketed the drugs after they were aware of the risks and failed to provide adequate warnings to medical professionals and consumers.
GranuFlo lawsuits have been consolidated in a multidistrict litigation (MDL) to streamline the legal process and expedite trial dates. Fresenius continues to claim that the lawsuits are without merit and has not entered into settlement negotiations at this time.
A wrongful death lawsuit was filed in Alabama by Betty Lemmond whose husband, Dizzy Dean Lemmond died of a Granuflo heart attack after receiving dialysis treatments with the drug for about 2 months. Another wrongful death suit was filed by Waddell Bishop whose mother died of a heart attack after dialysis treatments. Many of the pending GranuFlo lawsuits are for wrongful death or serious disabilities and additional lawsuits are expected to be filed in the coming months.
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