What is the true scope of the Baxter’s legacy when it comes to Heparin? Is it the relatively small number of deaths reported by the FDA last summer, or is it a number of deaths that could reach into the thousands?
By now it must be known just how many doses of contaminated Heparin Baxter produced and distributed. Both Baxter and the FDA have to know at least that much, right? The FDA first started by recalling nine lots, then additional lots and then pulled all of the Chinese heparin. But just how broad of a problem does “nine lots” represent? Would anyone in the public or even the news media know?
I am still waiting for proof that that number didn’t reach into the millions of contaminated doses. Heparin is administered to millions of people each year. If all of the Heparin for even the shortened time period from the Fall 2007 thru the Spring of 2008 was contaminated, doesn’t that mean millions were poisoned? Why is the FDA not telling us more. I can understand when it is a Republican FDA, but why are the Democrats not doing better?
Now we learn from the FDA that getting the dosing right on Heparin requires intense monitoring. See our last blog. So doesn’t that mean that what the FDA and Baxter hasn’t told us includes that failure to control potency could have killed many more?
When dealing with an intravenous drug that is given to our sickest patients (like kidney dialysis patients) there must be a duty not just to make the drug perfect, but also to tell everyone who got the less than perfect drug, of what happened to them.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
FDA and Heparin Inspections
Yesterday, I railed against the FDA’s increasing inability to assure that our drug supply is pure. Earlier this week, our blogs quoted a familiar name, Janet Woodcock, about some of those same failings. Woodcock should be a familiar name to those who have followed the Heparin Catastrophe. It was Woodcock who last year testified to Congress about foreign inspections, the in wake of first reports of Heparin deaths.
Last year, Woodcock explained the new and improved approach of the FDA to Congress as follows:
FDA conducted more foreign inspections in Fiscal Year (FY) 2007 than any other in the Agency’s history. For example, in FY 2007, FDA conducted 332 inspections of foreign drug manufacturers, compared to 260 in FY 2004, 266 in FY 2005, and 212 in FY 2006. We plan to conduct 500 in FY 2009. While, inspections are an important component of the Agency’s systematic approach to ensuring the safety of imported medical products, they alone cannot fully address these challenges.
Well, the Heparin Catastrophe demonstrates how flawed the FDA’s approach has been. Eight American inspectors for all of China? The goal is to increase inspections from 300 to 500? That is like having 500 auditors for the entire IRS. And I wonder how many of those eight people will speak Chinese?
The Congressional hearings told about the horrors of Chinese drug facilities, just in terms of basic things like cleanliness, not even to mention sterility. Hopefully, massive increases in inspections will at least address those concerns. What good is it for doctors to wash their hands if the drugs they give aren’t sterile?
But the biggest problem the FDA faces is purity. While that sounds like the same thing, I refer to the sterility issue as assuring that bacteria or viruses don’t contaminate drugs. By purity, I mean that the drugs are diluted by a substance that is put in there to dilute the drug, by using cutting agents that are being cleverly disguised to look like the real thing, such as with OSCS and Heparin. The problem with the cutting agents that are disguised to look like the real thing is that these compounds are not innocuous like sugar,. They are in fact complex organic compounds that may have very complex and poorly understood consequences.
But just imagine that the cutting agent was as innocuous as sugar. Well, that would be fine if you weren’t giving it to a diabetic. The problem with any cutting agent is you don’t know who will be hypersensitive to it. The FDA can impose all of the stringent trial and research requirements it wants before approving a drug, but if what is actually sold under that label, isn’t pure, it is a disaster.
You are not going to catch clever counterfeiters with inspections. This type of misconduct can only be detected by rigorous and ever more vigilant testing for purity. It may never be practical to catch each new and progressively more clever attempt to dilute the purity of drugs. Which is why we should not allow any drug to be imported. But if that is too protectionist for the free marketers, and our global trading partners, then at a minimum we must ban the importation of drugs used for intravenous or other sterile administration.
As all Baxter does, according to its Chairman Robert Parkinson is, “manufacture products that are injected or infused or inhaled by patients who need them to stay alive,” Baxter should never have imported any part of what it sells. Baxter should begin its reparations for poisoning Americans by leading the U.S. drug industry towards this type of protectionism – protecting the American patient.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Last year, Woodcock explained the new and improved approach of the FDA to Congress as follows:
FDA conducted more foreign inspections in Fiscal Year (FY) 2007 than any other in the Agency’s history. For example, in FY 2007, FDA conducted 332 inspections of foreign drug manufacturers, compared to 260 in FY 2004, 266 in FY 2005, and 212 in FY 2006. We plan to conduct 500 in FY 2009. While, inspections are an important component of the Agency’s systematic approach to ensuring the safety of imported medical products, they alone cannot fully address these challenges.
Beyond Our Borders Initiative. The FDA Beyond Our Borders Initiative is a multi-pronged approach to promote and verify compliance of imported food, cosmetics, and medical products with FDA requirements. This Initiative includes increased FDA presence in China, increased FDA inspections, greater sharing and use of foreign competent authority inspection reports and other information, use of third party certification, and increased capacity building with countries that have less developed regulatory systems to ensure product safety.
Foreign Presence. China is one of the largest exporters of drug products for the U.S. market. Recently, FDA and HHS leadership, the Department of State, and the U.S. Ambassador to China committed to establishing an FDA office in China this year. On March 8, 2008, the Department of State approved FDA to place 13 total staff in China (eight FDA personnel and five Foreign Nationals). This staff will be responsible for building closer working relationships with our Chinese counterparts, carrying out inspections, and working with Chinese inspectors to provide training. FDA is in the process of making the necessary arrangements and preparing to hire staff. This effort builds on two recently-signed Memoranda of Agreements (MOA) with two Chinese FDA counterpart agencies that facilitate broader access to Chinese production facilities on an expedited basis. This is a significant step toward ensuring the safety and efficacy of medical products produced for the U.S. market.
FDA’s efforts will build stronger cooperative relationships with counterpart agencies in China, enhance technical cooperation with these agencies, and foster the flow of information between regulatory systems. Having an overseas presence in China will improve our ability to inspect facilities in China and, very importantly, foster greater interactions between FDA staff and Chinese manufacturers to help ensure that products shipped to the U.S. meet FDA standards for safety and manufacturing quality. In addition, FDA is working to establish beneficial collaborations with India, another large exporter of drug products to the U.S.
Well, the Heparin Catastrophe demonstrates how flawed the FDA’s approach has been. Eight American inspectors for all of China? The goal is to increase inspections from 300 to 500? That is like having 500 auditors for the entire IRS. And I wonder how many of those eight people will speak Chinese?
The Congressional hearings told about the horrors of Chinese drug facilities, just in terms of basic things like cleanliness, not even to mention sterility. Hopefully, massive increases in inspections will at least address those concerns. What good is it for doctors to wash their hands if the drugs they give aren’t sterile?
But the biggest problem the FDA faces is purity. While that sounds like the same thing, I refer to the sterility issue as assuring that bacteria or viruses don’t contaminate drugs. By purity, I mean that the drugs are diluted by a substance that is put in there to dilute the drug, by using cutting agents that are being cleverly disguised to look like the real thing, such as with OSCS and Heparin. The problem with the cutting agents that are disguised to look like the real thing is that these compounds are not innocuous like sugar,. They are in fact complex organic compounds that may have very complex and poorly understood consequences.
But just imagine that the cutting agent was as innocuous as sugar. Well, that would be fine if you weren’t giving it to a diabetic. The problem with any cutting agent is you don’t know who will be hypersensitive to it. The FDA can impose all of the stringent trial and research requirements it wants before approving a drug, but if what is actually sold under that label, isn’t pure, it is a disaster.
You are not going to catch clever counterfeiters with inspections. This type of misconduct can only be detected by rigorous and ever more vigilant testing for purity. It may never be practical to catch each new and progressively more clever attempt to dilute the purity of drugs. Which is why we should not allow any drug to be imported. But if that is too protectionist for the free marketers, and our global trading partners, then at a minimum we must ban the importation of drugs used for intravenous or other sterile administration.
As all Baxter does, according to its Chairman Robert Parkinson is, “manufacture products that are injected or infused or inhaled by patients who need them to stay alive,” Baxter should never have imported any part of what it sells. Baxter should begin its reparations for poisoning Americans by leading the U.S. drug industry towards this type of protectionism – protecting the American patient.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
The FDA versus Imported drugs
The FDA versus Imported drugs. This issue, while it might seem minor to the larger debate about import restrictions and protectionism, is perhaps one of the most important questions that the Obama administration and Congress must address. Importing drugs or raw materials for drugs from overseas could rival auto imports in terms of national importance for at least two reasons:
First, the pharmaceutical industry is one of the United States’ largest manufacturing businesses, and a growing one at that.
Second, mandating safety in pharmaceuticals is a far more difficult process than checking the emission or safety equipment on a car.
Imagine, that the Bush Administration had simply decided to trust Korean importers of automobiles to put catalytic converters on cars, never bothering to actually look under the hood. Or even more extreme, the Administration didn’t even check to see if cars came with seatbelts. Seems absurd. No auto manufacturer would even try getting away with that.
Yet, allowing an exponential growth in the number of foreign drug plants while making only an incremental increase in the number of inspectors of such plants, is even more absurd. The health risk from increasing pollution might be considerable, but it would be slow and indirect. If a car didn’t come with a seatbelt, the consumer could simply refuse to buy it.
But if your drugs are contaminated, they can kill, almost immediately and without warning. We take the safety of our drugs for granted. We are not junkies buying crack on the street. We are buying drugs from established American firms with at least the tacit belief that the FDA is protecting us. We should be able to trust our drug makers and be confident that these drugs are safe for consumption.
It is such a cliché that the cost of U.S. healthcare is increased because of the onerous government regulations. Go to Europe or Mexico for the latest advances because their government isn’t slowing down the development of new treatments by over demanding trials. One of the biggest flaws in the U.S. healthcare system is the total fiction that our drugs are pure and contain what the label says.
Tomorrow, we will discuss the FDA’s flawed Beyond Our Borders Initiative.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
First, the pharmaceutical industry is one of the United States’ largest manufacturing businesses, and a growing one at that.
Second, mandating safety in pharmaceuticals is a far more difficult process than checking the emission or safety equipment on a car.
Imagine, that the Bush Administration had simply decided to trust Korean importers of automobiles to put catalytic converters on cars, never bothering to actually look under the hood. Or even more extreme, the Administration didn’t even check to see if cars came with seatbelts. Seems absurd. No auto manufacturer would even try getting away with that.
Yet, allowing an exponential growth in the number of foreign drug plants while making only an incremental increase in the number of inspectors of such plants, is even more absurd. The health risk from increasing pollution might be considerable, but it would be slow and indirect. If a car didn’t come with a seatbelt, the consumer could simply refuse to buy it.
But if your drugs are contaminated, they can kill, almost immediately and without warning. We take the safety of our drugs for granted. We are not junkies buying crack on the street. We are buying drugs from established American firms with at least the tacit belief that the FDA is protecting us. We should be able to trust our drug makers and be confident that these drugs are safe for consumption.
It is such a cliché that the cost of U.S. healthcare is increased because of the onerous government regulations. Go to Europe or Mexico for the latest advances because their government isn’t slowing down the development of new treatments by over demanding trials. One of the biggest flaws in the U.S. healthcare system is the total fiction that our drugs are pure and contain what the label says.
Tomorrow, we will discuss the FDA’s flawed Beyond Our Borders Initiative.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
More From the CDC on Heparin Adverse Reactions and Deaths
EDITORS NOTE: Below is the full text of the CDC release at http://cdc.gov/MMWR/preview/mmwrhtml/mm57e201a1.htm While much of this information has been previously reported, as we did further research into the full spread of this catastrophe, a review of this article has illuminated several issues:
- The Date of Onset is Clearly as early as November 19, 2007. We are skeptical that the problem doesn’t begin earlier, but there is no question that any adverse event with heparin that occurred between November 19 and the initial reports in January 2008, is suspect.
- Dialyzers manufactured by Fresenius Medical Care (Waltham, Massachusetts), were being used in 26 (40%) of the early episodes.
- The full extent of the problem is still evolving.
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
Acute Allergic-Type Reactions Among Patients Undergoing Hemodialysis — Multiple States, 2007–2008
CDC is investigating an outbreak of acute allergic-type reactions among patients who have undergone hemodialysis since November 19, 2007. The majority of reactions have occurred among adult hemodialysis patients, with onset within minutes of initiating a hemodialysis session. Although the cause of the outbreak is unknown and remains under investigation, the majority of reactions occurred in patients who received intravenous heparin produced by Baxter Healthcare Corporation (Deerfield, Illinois). Baxter voluntarily recalled nine lots of heparin multidose vials after learning of these adverse events among patients who received heparin during dialysis. This report describes the ongoing investigation.
CDC was first notified on January 7, 2008, by the Missouri Department of Health and Senior Services (MDHSS) of allergic-type reactions among pediatric hemodialysis patients that occurred beginning November 19, 2007, at a pediatric hospital. The reactions had been reported to MDHSS by a health-care provider at the hospital. The symptoms occurred within minutes of dialysis initiation and included facial swelling, tachycardia, hypotension, urticaria, and nausea. A total of eight episodes of acute allergic-type reactions have been identified as occurring among four patients at the pediatric hospital during November 19, 2007–January 15, 2008. These reactions were reviewed by a clinical allergist and were determined to be consistent with anaphylactic or anaphylactoid reaction.
Upon learning of the initial cluster, CDC solicited reports of similar allergic-type reactions among hemodialysis patients nationally through nephrology e-mail lists and public health notifications. In response to these case-finding measures, CDC was contacted on January 9, 2008, by a dialysis supply company that had received reports during the previous 2-week period of approximately 50 similar reactions among adult hemodialysis patients at dialysis facilities in six states. A second supply company reported learning of similar reactions from dialysis facilities as early as December 10, 2007. CDC alerted the Food and Drug Administration (FDA) to these nationwide reports of allergic-type reactions on January 9, 2008, and has been collaborating with FDA on the investigation.
As part of the investigation, CDC has created a working case definition for these reactions. A confirmed case of acute allergic-type reaction has been defined as an episode of anaphylactic or anaphylactoid reaction characterized by angioedema (particularly swelling of lips/mouth, tongue, throat, or eyelids) or urticaria. A probable case has been defined as an episode that includes at least two of the following signs and symptoms: 1) generalized or localized sensations of warmth; 2) numbness or tingling of the extremities; 3) difficulty swallowing; 4) shortness of breath, audible wheezing, or chest tightness; 5) low blood pressure/tachycardia; or 6) nausea or vomiting.
Of the episodes reported as of January 30, CDC has identified 65 confirmed or probable cases among 53 hemodialysis patients that occurred during November 19, 2007–January 21, 2008, at 19 dialysis facilities in 12 states. CDC currently is investigating an additional 36 possible cases. Most reactions resolved after interruption of the dialysis session or treatment with diphenhydramine or steroids at the facility. Other than the eight episodes reported by MDHSS, all cases have occurred among adults.
One common factor among the cases being investigated was receipt of heparin (1,000 units/mL) from 30-mL or 10-mL vials manufactured by Baxter. Intravenous heparin is administered during most hemodialysis sessions to prevent clotting of the access and dialysis circuit. In 61 (94%) of the 65 cases, the affected patient received Baxter heparin during hemodialysis. Dialyzers from four different companies were being used when the reactions occurred. The most commonly used dialyzers, manufactured by Fresenius Medical Care (Waltham, Massachusetts), were being used in 26 (40%) of the episodes. Other exposures have not been ruled out as potential causes of the reactions, and CDC is conducting additional epidemiologic studies to examine those exposures.
On January 17, 2008, Baxter announced a voluntary recall of nine lots of heparin, based on reports the company had received (1). All nine lots were produced at a single plant; eight of the nine lots were produced during September–November 2007. Despite the January 17 recall, an additional reaction occurred on January 21, 2008, after a hemodialysis patient was administered Baxter heparin from one of the recalled lots. CDC has found indications of delays in removing the recalled lots of heparin from distribution, which might result in continued exposures. In addition, these reactions might not be limited to hemodialysis settings. One cardiac-care facility has reported seven allergic-type reactions among cardiac patients who received heparin from lots that were later recalled. CDC and state health departments are investigating these reactions.
Reported by: G Turabelidze, MD, Missouri Dept of Health and Senior Svcs; A Elward, MD, Washington Univ School of Medicine; M Jones, BJC Healthcare, St. Louis, Missouri. PR Patel, MD, M Arduino, DrPH, C Gould, MD, N Shehab, PharmD, K Sunkavalli, MPH, Div of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases; S Schillie, MD, D Blossom, MD, A Kallen, MD, J Jaeger, MD, EIS officers, CDC.
Editorial Note:
The temporal and geographic distribution of these reactions in a discrete population of patients suggests common exposure to a health-care product with wide distribution in the United States. Previous clusters of acute allergic-type reactions among hemodialysis patients have been attributed to certain types of dialyzer membranes, ethylene oxide (used by the manufacturer as a sterilant), angiotensin-converting enzyme inhibitors, and the reuse of dialyzers (2,3). However, based on preliminary findings, these previously recognized causes of allergic-type reactions in dialysis patients are unlikely to explain this outbreak. Heparin is a biologic product rarely associated with anaphylactic reactions (4).
CDC is conducting additional case-finding activities and epidemiologic studies to define the scope of the outbreak and is exploring options for laboratory testing to further characterize these reactions. Health-care providers should 1) immediately discontinue use of and segregate the recalled lots of heparin, 2) report medication rea ctions to MedWatch, the online FDA reporting system for adverse medication events,* and 3) report to their state or local health departments any acute allergic-type reactions that have occurred since November 2007 in patients receiving hemodialysis or intravenous medication infusion. Health departments are asked to report reactions to CDC by telephone (404-639-4514 or 404-639-4273) or e-mail (dblossom@cdc.gov or ppatel@cdc.gov).
References
Baxter Healthcare Corporation. Urgent product recall. Rockville, MD: Food and Drug Administration; 2008. Available at http://www.fda.gov/medwatch/safety/2008/heparin_recall_01-17-2008.pdf.
Arduino MJ. CDC investigations of noninfectious outbreaks of adverse events in hemodialysis facilities, 1979–1999. Semin Dial 2000;13: 86–91.
CDC. Epidemiologic notes and reports of acute allergic reactions associated with reprocessed hemodialyzers—Virginia, 1989. MMWR 1989;38:873–4.
Berkun Y, Haviv YS, Schwartz LB, Shalit M. Heparin-induced recurrent anaphylaxis. Clin Exp Allergy 2004;34:1916–8.
* Available at http://www.fda.gov/medwatch.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
- The Date of Onset is Clearly as early as November 19, 2007. We are skeptical that the problem doesn’t begin earlier, but there is no question that any adverse event with heparin that occurred between November 19 and the initial reports in January 2008, is suspect.
- Dialyzers manufactured by Fresenius Medical Care (Waltham, Massachusetts), were being used in 26 (40%) of the early episodes.
- The full extent of the problem is still evolving.
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
Acute Allergic-Type Reactions Among Patients Undergoing Hemodialysis — Multiple States, 2007–2008
CDC is investigating an outbreak of acute allergic-type reactions among patients who have undergone hemodialysis since November 19, 2007. The majority of reactions have occurred among adult hemodialysis patients, with onset within minutes of initiating a hemodialysis session. Although the cause of the outbreak is unknown and remains under investigation, the majority of reactions occurred in patients who received intravenous heparin produced by Baxter Healthcare Corporation (Deerfield, Illinois). Baxter voluntarily recalled nine lots of heparin multidose vials after learning of these adverse events among patients who received heparin during dialysis. This report describes the ongoing investigation.
CDC was first notified on January 7, 2008, by the Missouri Department of Health and Senior Services (MDHSS) of allergic-type reactions among pediatric hemodialysis patients that occurred beginning November 19, 2007, at a pediatric hospital. The reactions had been reported to MDHSS by a health-care provider at the hospital. The symptoms occurred within minutes of dialysis initiation and included facial swelling, tachycardia, hypotension, urticaria, and nausea. A total of eight episodes of acute allergic-type reactions have been identified as occurring among four patients at the pediatric hospital during November 19, 2007–January 15, 2008. These reactions were reviewed by a clinical allergist and were determined to be consistent with anaphylactic or anaphylactoid reaction.
Upon learning of the initial cluster, CDC solicited reports of similar allergic-type reactions among hemodialysis patients nationally through nephrology e-mail lists and public health notifications. In response to these case-finding measures, CDC was contacted on January 9, 2008, by a dialysis supply company that had received reports during the previous 2-week period of approximately 50 similar reactions among adult hemodialysis patients at dialysis facilities in six states. A second supply company reported learning of similar reactions from dialysis facilities as early as December 10, 2007. CDC alerted the Food and Drug Administration (FDA) to these nationwide reports of allergic-type reactions on January 9, 2008, and has been collaborating with FDA on the investigation.
As part of the investigation, CDC has created a working case definition for these reactions. A confirmed case of acute allergic-type reaction has been defined as an episode of anaphylactic or anaphylactoid reaction characterized by angioedema (particularly swelling of lips/mouth, tongue, throat, or eyelids) or urticaria. A probable case has been defined as an episode that includes at least two of the following signs and symptoms: 1) generalized or localized sensations of warmth; 2) numbness or tingling of the extremities; 3) difficulty swallowing; 4) shortness of breath, audible wheezing, or chest tightness; 5) low blood pressure/tachycardia; or 6) nausea or vomiting.
Of the episodes reported as of January 30, CDC has identified 65 confirmed or probable cases among 53 hemodialysis patients that occurred during November 19, 2007–January 21, 2008, at 19 dialysis facilities in 12 states. CDC currently is investigating an additional 36 possible cases. Most reactions resolved after interruption of the dialysis session or treatment with diphenhydramine or steroids at the facility. Other than the eight episodes reported by MDHSS, all cases have occurred among adults.
One common factor among the cases being investigated was receipt of heparin (1,000 units/mL) from 30-mL or 10-mL vials manufactured by Baxter. Intravenous heparin is administered during most hemodialysis sessions to prevent clotting of the access and dialysis circuit. In 61 (94%) of the 65 cases, the affected patient received Baxter heparin during hemodialysis. Dialyzers from four different companies were being used when the reactions occurred. The most commonly used dialyzers, manufactured by Fresenius Medical Care (Waltham, Massachusetts), were being used in 26 (40%) of the episodes. Other exposures have not been ruled out as potential causes of the reactions, and CDC is conducting additional epidemiologic studies to examine those exposures.
On January 17, 2008, Baxter announced a voluntary recall of nine lots of heparin, based on reports the company had received (1). All nine lots were produced at a single plant; eight of the nine lots were produced during September–November 2007. Despite the January 17 recall, an additional reaction occurred on January 21, 2008, after a hemodialysis patient was administered Baxter heparin from one of the recalled lots. CDC has found indications of delays in removing the recalled lots of heparin from distribution, which might result in continued exposures. In addition, these reactions might not be limited to hemodialysis settings. One cardiac-care facility has reported seven allergic-type reactions among cardiac patients who received heparin from lots that were later recalled. CDC and state health departments are investigating these reactions.
Reported by: G Turabelidze, MD, Missouri Dept of Health and Senior Svcs; A Elward, MD, Washington Univ School of Medicine; M Jones, BJC Healthcare, St. Louis, Missouri. PR Patel, MD, M Arduino, DrPH, C Gould, MD, N Shehab, PharmD, K Sunkavalli, MPH, Div of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases; S Schillie, MD, D Blossom, MD, A Kallen, MD, J Jaeger, MD, EIS officers, CDC.
Editorial Note:
The temporal and geographic distribution of these reactions in a discrete population of patients suggests common exposure to a health-care product with wide distribution in the United States. Previous clusters of acute allergic-type reactions among hemodialysis patients have been attributed to certain types of dialyzer membranes, ethylene oxide (used by the manufacturer as a sterilant), angiotensin-converting enzyme inhibitors, and the reuse of dialyzers (2,3). However, based on preliminary findings, these previously recognized causes of allergic-type reactions in dialysis patients are unlikely to explain this outbreak. Heparin is a biologic product rarely associated with anaphylactic reactions (4).
CDC is conducting additional case-finding activities and epidemiologic studies to define the scope of the outbreak and is exploring options for laboratory testing to further characterize these reactions. Health-care providers should 1) immediately discontinue use of and segregate the recalled lots of heparin, 2) report medication rea ctions to MedWatch, the online FDA reporting system for adverse medication events,* and 3) report to their state or local health departments any acute allergic-type reactions that have occurred since November 2007 in patients receiving hemodialysis or intravenous medication infusion. Health departments are asked to report reactions to CDC by telephone (404-639-4514 or 404-639-4273) or e-mail (dblossom@cdc.gov or ppatel@cdc.gov).
References
Baxter Healthcare Corporation. Urgent product recall. Rockville, MD: Food and Drug Administration; 2008. Available at http://www.fda.gov/medwatch/safety/2008/heparin_recall_01-17-2008.pdf.
Arduino MJ. CDC investigations of noninfectious outbreaks of adverse events in hemodialysis facilities, 1979–1999. Semin Dial 2000;13: 86–91.
CDC. Epidemiologic notes and reports of acute allergic reactions associated with reprocessed hemodialyzers—Virginia, 1989. MMWR 1989;38:873–4.
Berkun Y, Haviv YS, Schwartz LB, Shalit M. Heparin-induced recurrent anaphylaxis. Clin Exp Allergy 2004;34:1916–8.
* Available at http://www.fda.gov/medwatch.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney