2008 Chinese heparin adulteration, refers to heparin adulteration incidents that occurred in the United States of America in 2008. Pharmaceutical company Baxter International subcontracted the creation of precursor chemicals of heparin to Scientific Protein Laboratories, an American company with production facilities located in China. Scientific Protein Laboratories then used counterfeit precursors to create the chemicals ordered. Baxter then sold this adulterated heparin in the US, which killed 81 people, and left 785 severely injured. This caught the attention of the media and the USA Food and Drug Administration leading to numerous ongoing lawsuits.
Overviewedit
The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories.[1][2][3] The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed to be linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also received 785 reports of serious injuries associated with the drug's use.[4] According to The New York Times, "problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock."[2]
Upon investigation of these adverse events by the FDA, academic institutions, and the involved pharmaceutical companies, the contaminant was identified as an "over-sulfated" derivative of chondroitin sulfate, a closely related substance obtained from mammal or fish cartilage and often used as a treatment for arthritis.[1][7] Since over-sulfated chondroitin is not a naturally occurring molecule, costs a fraction of true heparin starting material, and mimics the in-vitro properties of heparin, the counterfeit was almost certainly intentional as opposed to an accidental lapse in manufacturing.[8] The raw heparin batches were found to have been cut from 2–60% with chondroitin and motivation for the adulteration was attributed to a combination of cost savings and a shortage of suitable pigs in mainland China.
When the FDA conducted an inspection of Baxter's Chinese heparin supplier, it found serious deficiencies at the facility, which the FDA detailed in a warning letter.[9][10]
The warning letter detailed that the company failed to monitor changes in the impurity profile of incoming heparin active raw material, to adequately investigate out-of-specification results, to document actual processing steps in batch records, to validate all critical steps in the process, to qualify all suppliers, and to use valid methods to test products.
The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas upstream processors of finished active pharmaceutical ingredients such as heparin. However, according to the internationally harmonized guideline, ICH Q7, API manufacturers are fully responsible for qualifying their suppliers through on-site audits, testing, and regular communications.
^ abc. Time magazine. 2008. Archived from the original on 21 November 2008. Retrieved 2008-11-16.
^ abHarris, Gardiner; Walt Bogdanich (March 6, 2008). "Drug Tied to China Had Contaminant, F.D.A. Says". The New York Times. from the original on December 11, 2008. Retrieved 2008-03-19.
^Harris, Gardiner; Walt Bogdanich (March 7, 2008). "German Authorities Report Problems With Blood Thinner". The New York Times. Retrieved 2008-06-11.
^Harris, Gardiner (April 22, 2008). "U.S. Identifies Tainted Heparin in 11 Countries". The New York Times. from the original on December 11, 2008. Retrieved 2008-06-11.
^CBS News. . Archived from the original on 2012-10-23.
^FDA informational page with information and links about FDA investigation.
^Bogdanich, Walt (March 20, 2008). "Heparin Find May Point to Chinese Counterfeiting". The New York Times. Retrieved 2008-03-20.
^"Warning Letter: Changzhou SPL Company, Ltd (a/k/a "Kaipu")". FDA Warning letter. FDA. Retrieved 28 July 2010.
^Harris, Gardiner (February 14, 2008). "Chinese Factory Linked to Drug Under Inquiry in U.S." The New York Times. from the original on December 9, 2008. Retrieved 2008-02-18. Public health officials noticed a problem with heparin supplies late last year when children undergoing dialysis at a Missouri hospital had severe allergic reactions. As officials investigated, they discovered hundreds of similar cases. Baxter initially recalled some of the product, but the problems persisted.
April 14, 2024
2008, chinese, heparin, adulteration, refers, heparin, adulteration, incidents, that, occurred, united, states, america, 2008, pharmaceutical, company, baxter, international, subcontracted, creation, precursor, chemicals, heparin, scientific, protein, laborato. 2008 Chinese heparin adulteration refers to heparin adulteration incidents that occurred in the United States of America in 2008 Pharmaceutical company Baxter International subcontracted the creation of precursor chemicals of heparin to Scientific Protein Laboratories an American company with production facilities located in China Scientific Protein Laboratories then used counterfeit precursors to create the chemicals ordered Baxter then sold this adulterated heparin in the US which killed 81 people and left 785 severely injured This caught the attention of the media and the USA Food and Drug Administration leading to numerous ongoing lawsuits Overview editThe raw material for the recalled heparin batches was processed in China from pig s intestines by the American pharmaceutical firm Scientific Protein Laboratories 1 2 3 The U S Food and Drug Administration was quoted as stating that at least 81 deaths were believed to be linked to a raw heparin ingredient imported from the People s Republic of China and that they had also received 785 reports of serious injuries associated with the drug s use 4 According to The New York Times problems with heparin reported to the agency include difficulty breathing nausea vomiting excessive sweating and rapidly falling blood pressure that in some cases led to life threatening shock 2 In March 2008 due to contamination of the raw heparin stock imported from mainland China major recalls of heparin a substance widely used as an injectable anticoagulant were announced by the U S Food and Drug Administration FDA 5 6 1 Upon investigation of these adverse events by the FDA academic institutions and the involved pharmaceutical companies the contaminant was identified as an over sulfated derivative of chondroitin sulfate a closely related substance obtained from mammal or fish cartilage and often used as a treatment for arthritis 1 7 Since over sulfated chondroitin is not a naturally occurring molecule costs a fraction of true heparin starting material and mimics the in vitro properties of heparin the counterfeit was almost certainly intentional as opposed to an accidental lapse in manufacturing 8 The raw heparin batches were found to have been cut from 2 60 with chondroitin and motivation for the adulteration was attributed to a combination of cost savings and a shortage of suitable pigs in mainland China When the FDA conducted an inspection of Baxter s Chinese heparin supplier it found serious deficiencies at the facility which the FDA detailed in a warning letter 9 10 The warning letter detailed that the company failed to monitor changes in the impurity profile of incoming heparin active raw material to adequately investigate out of specification results to document actual processing steps in batch records to validate all critical steps in the process to qualify all suppliers and to use valid methods to test products The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas upstream processors of finished active pharmaceutical ingredients such as heparin However according to the internationally harmonized guideline ICH Q7 API manufacturers are fully responsible for qualifying their suppliers through on site audits testing and regular communications See also editList of medicine contamination incidentsReferences edit a b c Heparin s Deadly Side Effects Time magazine 2008 Archived from the original on 21 November 2008 Retrieved 2008 11 16 a b Harris Gardiner Walt Bogdanich March 6 2008 Drug Tied to China Had Contaminant F D A Says The New York Times Archived from the original on December 11 2008 Retrieved 2008 03 19 Harris Gardiner Walt Bogdanich March 7 2008 German Authorities Report Problems With Blood Thinner The New York Times Retrieved 2008 06 11 Harris Gardiner April 22 2008 U S Identifies Tainted Heparin in 11 Countries The New York Times Archived from the original on December 11 2008 Retrieved 2008 06 11 CBS News Blood thinning drug under suspicion Archived from the original on 2012 10 23 FDA informational page with information and links about FDA investigation Zawisza Julie 2008 03 29 FDA Media Briefing on Heparin PDF U S Food and Drug Administration Retrieved 2008 04 23 Bogdanich Walt March 20 2008 Heparin Find May Point to Chinese Counterfeiting The New York Times Retrieved 2008 03 20 Warning Letter Changzhou SPL Company Ltd a k a Kaipu FDA Warning letter FDA Retrieved 28 July 2010 Harris Gardiner February 14 2008 Chinese Factory Linked to Drug Under Inquiry in U S The New York Times Archived from the original on December 9 2008 Retrieved 2008 02 18 Public health officials noticed a problem with heparin supplies late last year when children undergoing dialysis at a Missouri hospital had severe allergic reactions As officials investigated they discovered hundreds of similar cases Baxter initially recalled some of the product but the problems persisted Retrieved from https en wikipedia org w index php title 2008 Chinese heparin adulteration amp oldid 1201472565, wikipedia, wiki, book, books, library,
