11/20/2008
Despite previous beliefs that Heparin contaminated with over sulfated chondroitin sulfate was in circulation in the United States beginning in the Fall of 2007, new information confirms that several manufacturers received contaminated heparin API (active pharmaceutical ingredient) from Scientific Protein Laboratories, L.L.C. as early as December 2006.
This means that contaminated finished heparin could have been ingested by patients in the U.S. earlier than Fall of 2007. Companies who received contaminated Heparin API before Fall of 2007 include B. Braun, Covidien, Becton Dickinson, Beckman, Emisphere, and Medefil.
This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation. The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.
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: Information on Adverse Event Reports and Heparin
Information on Adverse Event Reports and Heparin
The chart below shows numbers of deaths reported after heparin administration that occurred and were submitted to FDA from January 1, 2007 through May 31, 2008. The reports are sorted according to the date of the medical event in the report, indicated in the first column. This date may be different than the date of death.
The second column indicates the number of deaths reported after heparin administration, regardless of cause.
The third column indicates the number of death reports that included one or more allergic symptom(s) or symptoms of hypotension (low blood pressure). These are the events that prompted a series of heparin recalls.
There have been 246 reports of death reported to FDA since January 1, 2007; 238 were reported to FDA on or after January 1, 2008.
Of the 149 reports that included one or more allergic symptom(s) or symptoms of hypotension and death, 146 were reported to FDA on or after January 1, 2008.
The fact that allergic symptoms or hypotension was reported does not mean that these were the cause of death in all cases.
FDA received reports of 97 patients who died without mention of allergy or hypotension. These patients died of a variety of causes.
In the majority of reports with a death outcome, there was not enough clinical information to assess the relationship between death and the use of heparin.
The recent internet posting from the Center for Devices and Radiological Health (CDRH) (http://www.fda.gov/cdrh/safety/heparin-qanda.html) states that CDRH has received reports of 11 deaths associated with heparin-containing devices. The CDRH reporting system is separate from the Adverse Event Reporting System (AERS) used to capture the reports counted below. It is possible that reports of one death were sent to both systems, and could potentially be counted twice.
www.heparin-law.com
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 chart below shows numbers of deaths reported after heparin administration that occurred and were submitted to FDA from January 1, 2007 through May 31, 2008. The reports are sorted according to the date of the medical event in the report, indicated in the first column. This date may be different than the date of death.
The second column indicates the number of deaths reported after heparin administration, regardless of cause.
The third column indicates the number of death reports that included one or more allergic symptom(s) or symptoms of hypotension (low blood pressure). These are the events that prompted a series of heparin recalls.
There have been 246 reports of death reported to FDA since January 1, 2007; 238 were reported to FDA on or after January 1, 2008.
Of the 149 reports that included one or more allergic symptom(s) or symptoms of hypotension and death, 146 were reported to FDA on or after January 1, 2008.
The fact that allergic symptoms or hypotension was reported does not mean that these were the cause of death in all cases.
FDA received reports of 97 patients who died without mention of allergy or hypotension. These patients died of a variety of causes.
In the majority of reports with a death outcome, there was not enough clinical information to assess the relationship between death and the use of heparin.
The recent internet posting from the Center for Devices and Radiological Health (CDRH) (http://www.fda.gov/cdrh/safety/heparin-qanda.html) states that CDRH has received reports of 11 deaths associated with heparin-containing devices. The CDRH reporting system is separate from the Adverse Event Reporting System (AERS) used to capture the reports counted below. It is possible that reports of one death were sent to both systems, and could potentially be counted twice.
www.heparin-law.com
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