There are indications that Fresenius
Medical Care (FMC) may have been aware of the increased risk of heart attack
and cardiopulmonary arrest posed by the drugs GranuFlo and NaturaLyte when the
drugs were released in 2003. It is clear that the company deliberately delayed
notifying the FDA and the public for at least several months after evidence of
the dangers became undeniable.
The world's largest supplier of hemodialysis equipment and supplies, FMC also operates over 1800 dialysis clinics in the U.S. GranuFlo and NaturaLyte are dialysates which are used to cleanse the blood during dialysis treatment. Granuflo is an acid concentrate powder and NaturaLyte is a liquid form of the same drug. The drugs differ from earlier dialysates because they contain acetate and acetic acid which are rapidly converted into bicarbonate by the liver.
During dialysis, the blood is removed from the body, cleansed with dialysates and bicarbonate buffers and returned to the body. Because GranuFlo and NaturaLyte are converted to bicarbonate much more rapidly than other dialysates, they can cause a bicarbonate overdose if the dosage of bicarbonate buffers is not adjusted regularly. A bicarbonate overdose can lead to a number of serious complications including heart attack, cardiopulmonary arrest and sudden death.
While there were clear early signs of problems with GranuFlo and NaturaLyte, Fresenius conducted an aggressive marketing campaign focused on non-owned clinics. By 2010, nearly half of the approximately 400,000 dialysis patients in the U.S. were receiving their treatments with GranuFlo and/or NaturaLyte. When the increased risk of heart attack caused by the drugs became clear, the company failed to notify the non-owned clinics they supplied of the risk.
Warnings Signs Ignored by FMC
Between 2004 and 2010, Fresenius apparently ignored evidence from their own clinics that their dialysates caused increased serum bicarbonate levels in patients that could be seen in pre-dialysis blood screenings. They should have known that these increased bicarbonate levels could lead to serious adverse health conditions including metabolic alkalosis, heart attack and death.
In 2010, Fresenius received a warning letter at their Waltham, MA manufacturing plant. Part of the complaint stated that FMC did not have standard protocols for dealing with complaints or adverse event reports about their products and they did not properly report the complaints or adverse events to the FDA.
In 2011, the company ordered an internal review of 667 FMC owned clinics and found that at least 941 patients had died during treatment with GranuFlo and NaturaLyte in 2010. A six page memo was sent to healthcare professionals in FMC clinics in November 2010 warning of the dangers and advising doctors that bicarbonate dosages needed to be adjusted monthly. The memo included information on patients in the highest risk groups for heart attacks during dialysis and contraindications for use of the drugs. No information was sent to doctors at non-owned clinics that purchased the drugs from Fresenius.
Medical professionals within Fresenius estimated that GranuFlo and NaturaLyte increased heart attack risks in patients with high pre-dialysis serum bicarbonate levels by as much as 6 times and significantly increased risks for patients with only slightly elevated levels.
In March 2012, the FDA received a copy of the FMC internal memo from an unknown source and instituted an inquiry. In response, Fresenius sent out a 2 page “Urgent Product Notification” on March 29 to non FMC clinics using the drugs. The memo advised doctors of the importance of pre-dialysis monitoring of serum bicarbonate levels when using GranuFlo and NaturaLyte.
The FDA issued a Class I recall on March 29, 2012 for GranuFlo and NaturaLyte manufactured after January 1, 2008. A Class I recall is the strongest action the FDA can take and is only issued if there is “a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death.” Although the dialysates remained on the market, the company was required to provide new labeling with adequate warnings and complete information on drug protocols and dosages.
Additionally, the Federal Food and Drug Administration issued a safety communication on May 25, 2012 warning doctors that they should know that the levels of citrates, acetic acid and acetate in dialysis solutions vary between products and manufacturers and should be considered when administering dialysis treatments.
An article published in the NY Times indicated that FDA was investigating the events leading up to the recall of Granuflo and NaturaLyte to determine if Fresenius, a German based company, had violated U.S. regulations in marketing the drugs and reporting adverse events.
The world's largest supplier of hemodialysis equipment and supplies, FMC also operates over 1800 dialysis clinics in the U.S. GranuFlo and NaturaLyte are dialysates which are used to cleanse the blood during dialysis treatment. Granuflo is an acid concentrate powder and NaturaLyte is a liquid form of the same drug. The drugs differ from earlier dialysates because they contain acetate and acetic acid which are rapidly converted into bicarbonate by the liver.
During dialysis, the blood is removed from the body, cleansed with dialysates and bicarbonate buffers and returned to the body. Because GranuFlo and NaturaLyte are converted to bicarbonate much more rapidly than other dialysates, they can cause a bicarbonate overdose if the dosage of bicarbonate buffers is not adjusted regularly. A bicarbonate overdose can lead to a number of serious complications including heart attack, cardiopulmonary arrest and sudden death.
While there were clear early signs of problems with GranuFlo and NaturaLyte, Fresenius conducted an aggressive marketing campaign focused on non-owned clinics. By 2010, nearly half of the approximately 400,000 dialysis patients in the U.S. were receiving their treatments with GranuFlo and/or NaturaLyte. When the increased risk of heart attack caused by the drugs became clear, the company failed to notify the non-owned clinics they supplied of the risk.
Warnings Signs Ignored by FMC
Between 2004 and 2010, Fresenius apparently ignored evidence from their own clinics that their dialysates caused increased serum bicarbonate levels in patients that could be seen in pre-dialysis blood screenings. They should have known that these increased bicarbonate levels could lead to serious adverse health conditions including metabolic alkalosis, heart attack and death.
In 2010, Fresenius received a warning letter at their Waltham, MA manufacturing plant. Part of the complaint stated that FMC did not have standard protocols for dealing with complaints or adverse event reports about their products and they did not properly report the complaints or adverse events to the FDA.
In 2011, the company ordered an internal review of 667 FMC owned clinics and found that at least 941 patients had died during treatment with GranuFlo and NaturaLyte in 2010. A six page memo was sent to healthcare professionals in FMC clinics in November 2010 warning of the dangers and advising doctors that bicarbonate dosages needed to be adjusted monthly. The memo included information on patients in the highest risk groups for heart attacks during dialysis and contraindications for use of the drugs. No information was sent to doctors at non-owned clinics that purchased the drugs from Fresenius.
Medical professionals within Fresenius estimated that GranuFlo and NaturaLyte increased heart attack risks in patients with high pre-dialysis serum bicarbonate levels by as much as 6 times and significantly increased risks for patients with only slightly elevated levels.
In March 2012, the FDA received a copy of the FMC internal memo from an unknown source and instituted an inquiry. In response, Fresenius sent out a 2 page “Urgent Product Notification” on March 29 to non FMC clinics using the drugs. The memo advised doctors of the importance of pre-dialysis monitoring of serum bicarbonate levels when using GranuFlo and NaturaLyte.
The FDA issued a Class I recall on March 29, 2012 for GranuFlo and NaturaLyte manufactured after January 1, 2008. A Class I recall is the strongest action the FDA can take and is only issued if there is “a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death.” Although the dialysates remained on the market, the company was required to provide new labeling with adequate warnings and complete information on drug protocols and dosages.
Additionally, the Federal Food and Drug Administration issued a safety communication on May 25, 2012 warning doctors that they should know that the levels of citrates, acetic acid and acetate in dialysis solutions vary between products and manufacturers and should be considered when administering dialysis treatments.
An article published in the NY Times indicated that FDA was investigating the events leading up to the recall of Granuflo and NaturaLyte to determine if Fresenius, a German based company, had violated U.S. regulations in marketing the drugs and reporting adverse events.
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