Baxter’s recall of its heparin is now wider than initially started, largely because the FDA feels that there is enough substitute heparin in the market place to replace the questionable heparin made by Baxter. Initially, the “FDA and Baxter concluded that
removing additional lots and doses of Baxter’s heparin from the market earlier would have created
more risk to patients requiring heparin therapy than the increased potential for experiencing an
adverse reaction.” See full press release at http://www.fda.gov/cder/drug/shortages/BaxterHeparinRecall2-28.pdf
According to the FDA press release:
“The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.
“The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter’s recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.
“Although the vast majority of the reports of adverse reactions have been associated with the multi- dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter’s recall will now include the remaining lots of those products and heparin sodium injection 5000 units/ mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.
“We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs,” said Peter J. Arduini, president of Baxter’s Medication Delivery business. “The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue.”
“Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.”
We hope that these recalls will be sufficient and that the supply control problems inherent in importing pork bi-products from a country like China, where we have had severe issues in establishing the purity of its products, will not cause more mayhem.
Is Heparin Epidemic Understated?
The FDA recall of Baxter Heparin identified a few fatalities and hundreds of adverse reactions to heparin, beginning in late December. However, a detailed examination of the timeline of problems with this drug clearly shows that it may have started as early as early November, and perhaps even earlier.
The problem with identifying the full scope of this problem, is that any adverse reaction or death that occurred before the FDA announced the recall on January 17, 2008, may not have been properly investigated. For example, the first identified problems in terms of the current announced investigation occurred on Nov. 19, 2007 Doctors at St. Louis Children’s Hospital. For Chicago Tribune story on timeline, click here. This was the first time a problem was identified, but the troublesome Heparin was packaged as early as September. If these lots had the contaminants, how do we know that there were countless adverse reactions and deaths associated with these batches?
Moreover, as the investigation has spread, it is clear that the contamination effected considerably more than the batches of the drug that were first identified as being toxic. While most American’s have a false confidence in the diagnostic infallibility of their doctors, we encounter cases every day, where even the most logical diagnostic conclusions are never considered. But with a secret contaminant in a drug with a long track record, it is highly likely that any death or adverse reaction that was caused by Heparin prior to the end of January, might have slipped by without further thought or investigation. How many people died of heparin contamination prior to the FDA announcement where no autopsy was performed?
Making the misdiagnosis even more probable is that the bulk of the people getting the tainted Heparin were people who were frail and at risk for sickness and death. The more frail the victim, the less likely the doctors are going to probe an adverse reaction, choosing the obvious (but likely incorrect conclusion) that the adverse reaction or death is a subset of the disease for which the Heparin is diagnosed. But the reality, the more frail the patient, the more likely that the contaminants will kill.
It is time for the FDA investigation, and for conscientious doctors, to take a second look at any serious health problem a Heparin recipient may have had, between September 1 and January 31. If the contamination is as widespread as it appears, then the investigation must not just grab onto the obvious cases, but dig deep to see if the adverse reactions started earlier. These frail patients are the canary in the coal mine. There adverse reactions may point us to the full scope of the epidemic of greed.
The problem with identifying the full scope of this problem, is that any adverse reaction or death that occurred before the FDA announced the recall on January 17, 2008, may not have been properly investigated. For example, the first identified problems in terms of the current announced investigation occurred on Nov. 19, 2007 Doctors at St. Louis Children’s Hospital. For Chicago Tribune story on timeline, click here. This was the first time a problem was identified, but the troublesome Heparin was packaged as early as September. If these lots had the contaminants, how do we know that there were countless adverse reactions and deaths associated with these batches?
Moreover, as the investigation has spread, it is clear that the contamination effected considerably more than the batches of the drug that were first identified as being toxic. While most American’s have a false confidence in the diagnostic infallibility of their doctors, we encounter cases every day, where even the most logical diagnostic conclusions are never considered. But with a secret contaminant in a drug with a long track record, it is highly likely that any death or adverse reaction that was caused by Heparin prior to the end of January, might have slipped by without further thought or investigation. How many people died of heparin contamination prior to the FDA announcement where no autopsy was performed?
Making the misdiagnosis even more probable is that the bulk of the people getting the tainted Heparin were people who were frail and at risk for sickness and death. The more frail the victim, the less likely the doctors are going to probe an adverse reaction, choosing the obvious (but likely incorrect conclusion) that the adverse reaction or death is a subset of the disease for which the Heparin is diagnosed. But the reality, the more frail the patient, the more likely that the contaminants will kill.
It is time for the FDA investigation, and for conscientious doctors, to take a second look at any serious health problem a Heparin recipient may have had, between September 1 and January 31. If the contamination is as widespread as it appears, then the investigation must not just grab onto the obvious cases, but dig deep to see if the adverse reactions started earlier. These frail patients are the canary in the coal mine. There adverse reactions may point us to the full scope of the epidemic of greed.
