Understated Adverse Reactions to Heparin

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.

Next: Baxter Widens Heparin Recall

For information on the recall, click here:

FDA Information

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Gordon Johnson is the Owner of the Johnson Law Office.

©Gordon S. Johnson, Jr. 2008

To contact us
call 800-992-9447

For Our Latest Information on Heparin go to our Blog:

Heparin Information

Heparin Glossary

The New England Journal of Medicine: MIT Study

FDA: Heparin Warning

Contaminated Heparin Can Do More than Kill

Heparin Lawsuit: Areas of Inquiry

FDA Press Releases

Scott v. Baxter Lawsuit

Reporting Heparin Problems

Understated Adverse Reactions

Baxter Widens Heparin Recall

FDA Intercepting Heparin

FDA Plans For Full-Time Staff in China

Heparin Purity - China Doesn't Seem to Care

Baxter Didn't Know About Absence of Inspection

German Heparin Also Contaminated

Heparin Contaminant Identified

Heparin Recall Timeline

Food and Drug Administration Globalization Act of 2008

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