The dialysates GranuFlo and NaturaLyte are used with
bicarbonate buffers to filter blood during hemodialysis treatments. These drugs
contain acetate and acetic acid that is converted into bicarbonate in the liver
at a more rapid rate than the compounds found in other dialysates. This rapid
rate of conversion can lead to a bicarbonate overdose and serious complications
including heart attack and cardiopulmonary arrest.
Elevated serum bicarbonate levels can cause metabolic alkalosis, an imbalance in the body's pH. Symptoms of this condition include cardiac arrhythmia (irregular heart beat), cardiac tachycardia (extremely rapid heartbeat), low blood pressure, muscle twitching, mental confusion, cyanosis ( a blue tint to the skin caused by lack of oxygen), slowed respirations, nausea, vomiting, diarrhea and numbness or tingling of the face, hands and feet.
Metabolic alkalosis has serious medical consequences if not treated immediately. Elevated serum bicarbonate levels can cause cardiopulmonary arrest, heart attack, hypoxia (oxygen deprivation to the brain), stroke, heart attack and sudden death.
Fresenius Medical Care and the FDA
Fresenius Medical Care (FMC), makers of GranuFlo and NaturaLyte, are the largest suppliers of dialysis equipment and products in the world. With more than 1800 company owned dialysis clinics in the United States, they are the largest single provider of dialysis treatments.
Recently filed lawsuits allege that the company was aware or should have been aware of the dangers inherent in their drugs when GranuFlo and NaturaLyte were introduced to the market in 2003. They further accuse Fresenius of failing to provide proper instructions and dosages for administering the drugs and of providing inadequate warnings about possible serious side effects.
A company review of 667 FMC clinics in 2011 disclosed that more than 900 patients died of heart attacks during dialysis in 2010. Following the review, the company issued an internal memo to FMC clinics warning of the need to monitor serum bicarbonate levels before and during dialysis when using GranuFlo or NaturaLyte and gave additional information for adjusting dosage levels monthly to minimize the risk of heart attack.
Although FMC supplied hundreds of non-owned clinics with the dialysates, medical professionals at these clinics were not notified of the changed treatment protocols or dosages for the drugs. The company also may have violated federal drug regulations by failing to report adverse events to the FDA.
After receiving a copy of the Fresenius internal memo from an anonymous source, the FDA sent an inquiry to Fresenius about the problems with GranuFlo in March 2012. The company responded by sending an “Urgent Product Safety Notification” to non-owned clinics with information about treatment protocols and dosages to be used with the products.
On March 29, 2012, the FDA did issue a Class I recall of Granuflo and NaturaLyte. A Class I recall is only issued if use or exposure to a product could result in serious adverse health consequences or death. The drugs remain on the market, but the recall forced FMC to provide new labeling with adequate warnings and instructions for using the drugs.
GranuFlo and NaturaLyte are contraindicated for use in patients with Cushing's Syndrome and Conn's Syndrome since overproduction of certain hormones caused by these diseases place the patients at greater risk of alkalosis. Individuals with COPD (chronic obstructive pulmonary disease) and other lung diseases and those with known hormone imbalances or serious cardiovascular disease should not use these dialysates.
Elevated serum bicarbonate levels can cause metabolic alkalosis, an imbalance in the body's pH. Symptoms of this condition include cardiac arrhythmia (irregular heart beat), cardiac tachycardia (extremely rapid heartbeat), low blood pressure, muscle twitching, mental confusion, cyanosis ( a blue tint to the skin caused by lack of oxygen), slowed respirations, nausea, vomiting, diarrhea and numbness or tingling of the face, hands and feet.
Metabolic alkalosis has serious medical consequences if not treated immediately. Elevated serum bicarbonate levels can cause cardiopulmonary arrest, heart attack, hypoxia (oxygen deprivation to the brain), stroke, heart attack and sudden death.
Fresenius Medical Care and the FDA
Fresenius Medical Care (FMC), makers of GranuFlo and NaturaLyte, are the largest suppliers of dialysis equipment and products in the world. With more than 1800 company owned dialysis clinics in the United States, they are the largest single provider of dialysis treatments.
Recently filed lawsuits allege that the company was aware or should have been aware of the dangers inherent in their drugs when GranuFlo and NaturaLyte were introduced to the market in 2003. They further accuse Fresenius of failing to provide proper instructions and dosages for administering the drugs and of providing inadequate warnings about possible serious side effects.
A company review of 667 FMC clinics in 2011 disclosed that more than 900 patients died of heart attacks during dialysis in 2010. Following the review, the company issued an internal memo to FMC clinics warning of the need to monitor serum bicarbonate levels before and during dialysis when using GranuFlo or NaturaLyte and gave additional information for adjusting dosage levels monthly to minimize the risk of heart attack.
Although FMC supplied hundreds of non-owned clinics with the dialysates, medical professionals at these clinics were not notified of the changed treatment protocols or dosages for the drugs. The company also may have violated federal drug regulations by failing to report adverse events to the FDA.
After receiving a copy of the Fresenius internal memo from an anonymous source, the FDA sent an inquiry to Fresenius about the problems with GranuFlo in March 2012. The company responded by sending an “Urgent Product Safety Notification” to non-owned clinics with information about treatment protocols and dosages to be used with the products.
On March 29, 2012, the FDA did issue a Class I recall of Granuflo and NaturaLyte. A Class I recall is only issued if use or exposure to a product could result in serious adverse health consequences or death. The drugs remain on the market, but the recall forced FMC to provide new labeling with adequate warnings and instructions for using the drugs.
GranuFlo and NaturaLyte are contraindicated for use in patients with Cushing's Syndrome and Conn's Syndrome since overproduction of certain hormones caused by these diseases place the patients at greater risk of alkalosis. Individuals with COPD (chronic obstructive pulmonary disease) and other lung diseases and those with known hormone imbalances or serious cardiovascular disease should not use these dialysates.
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