Medicine:List of medicine contamination incidents

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In medicinal chemistry, the term "contamination" is used to describe harmful intrusions, such as the presence of toxins or pathogens in pharmaceutical drugs.[1]

The following list encompasses notable medicine contamination and adulteration incidents.

  • 1937 Elixir sulfanilamide incident: S. E. Massengill Company used diethylene glycol as the solvent for the antibacterial sulfanilamide, leading to the 1938 passage of the Federal Food, Drug, and Cosmetic Act.[2][3]
  • 1942, Nose droppers were found to be contaminated by users to the detriment of subsequent users. Bacterial growth was found in all ephedrine and neosynephrin solutions that were examined.[4]
  • 1970s – 1985 Treatments for hemophilia derived from human blood were contaminated with HIV and hepatitis C and infected over 10,000 patients worldwide. The manufacturers of the affected products became aware of the contamination but continued to sell it. After the contaminated products were banned in many developed countries, sales were shifted to developing markets.
  • 1982 Chicago Tylenol murders: Tylenol pain-relief capsules were laced with potassium cyanide, leading to seven deaths.[5]
  • 2007 Panamanian Eduardo Arias discovered that toothpaste sold in his country was labeled as containing diethylene glycol, the same ingredient that had tainted cough syrup and killed 138 Panamanians in 2006. Panamanian officials discovered that the toothpaste had come from China and initiated a global response.[6][7][8] Also in May 2007, the same toothpaste was found in some Costa Rican stores. Fast action by the Ministry of Health, and notification through the media, prevented poisonings due to this product. This event was linked to the death sentence of a former pharmaceuticals control officer in China, as the Costa Rican newspaper La Nación reported on its issue of May 30.[9] On June 4, 2007, a press release by the Chinese Foreign Ministry[10] cited an earlier study in China[11] which concluded that up to 15.6% diethylene glycol in toothpaste is safe. In June 2007, counterfeit Colgate toothpaste imported from China was found to be contaminated with DEG, and several people in the eastern US reported experiencing headaches and pain after using the product.[12] The same occurred in Spain with a false Colgate toothpaste, which contained 6% DEG. The tainted products could be identified by the claim to be manufactured in South Africa by Colgate-Palmolive South Africa LTD; they were 5 oz/100 ml tubes (a size which Colgate does not sell in the United States) and their packaging contained numerous misspellings on the labels. Colgate-Palmolive claimed it does not import products from South Africa into the United States or Canada and that DEG is never and was never used in any of its products anywhere in the world. These counterfeit products were found in smaller mom and pop stores, dollar stores, and discount stores in at least four states.[13] In July 2007, diethylene glycol was found in counterfeit Sensodyne toothpaste, on sale at a car boot sale in Derbyshire, England.[14]
  • 2007 Toxic cough syrup in Panama: Pharmaceutical manufacturers used diethylene glycol, which they believed to be glycerine, to make cough syrup.[15]
  • 2008 Chinese heparin adulteration[16][17]
  • 2009, 84 Nigerian children were reported to have died after being given "My Pikin", a teething syrup contaminated with diethylene glycol.[18]
  • 2012: (As of November 2012) in the New England Compounding Center meningitis outbreak, 753 cases of fungal infection occurred with 64 deaths due to contaminated injectable medication.
  • 2012: 2012 Pakistan fake medicine crisis
  • 2017: medical cannabis in California found to contain dangerous bacteria and fungi, causing at least one fatality.[19]
  • 2012 – 2018: From 2012 to 2018 massive amounts of generic versions of an entire class of angiotensin II inhibitor blood pressure medications (collectively called "sartans") were made with contaminated ingredients. Patients receiving these drugs were exposed to genotoxic and carcinogenic N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) from 2012 until the drugs were recalled from the world drug market in 2018. The problem began in 2012, when the process for making tetrazole, a chemical intermediate in the production of various angiotensin II inhibitor medications for hypertension (popularly known by their common drug name suffix "sartan") was changed by generic drug manufacturers in favor of several cheaper and more efficient processes. These changes caused drugs made with tetrazole to be contaminated with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which cause genetic damage and cancer.[20] This contamination was not detected until 2018. The incident, according to medicinal chemist and pharmaceutical industry blogger Dr. Derek Lowe, points to a greater problem. Generic drug manufacturers often change the way in which prescription drug ingredients are made in order to lower costs of making them, so this kind of contamination may be more widespread and undetected in generic drugs.[21]

See also

References

  1. ↑ Bohrer, D. (2012). "Preface". Sources of Contamination in Medicinal Products and Medical Devices. John Wiley & Sons. ISBN 9781118449059. https://books.google.com/books?id=w-u6D7mbNdcC. Retrieved 2023-01-09. 
  2. ↑ "Medicine: Post-Mortem". Time magazine. December 20, 1937. http://www.time.com/time/magazine/article/0,9171,758704,00.html. "Then, two months ago, fatality knocked at its door. A new mixture of a new drug (sulfanilamide) with a new solvent (diethylene glycol), which Dr. Massengill's salesmen sold as Elixir Sulfanilamide-Massengill, was discovered to be killing its users" 
  3. ↑ "Wallace Reveals How Federal Agents Traced Elixir to Halt Fatalities". New York Times. November 26, 1937. https://www.nytimes.com/1937/11/26/archives/death-drug-hunt-covered-15-states-wallace-reveals-how-federal.html. "A graphic story of a race against death from "elixir sulfanilamide," carried on by the Food and Drug Administration in fifteen States from Virginia to California, a race not won until ninety-three persons had died after taking the lethal dose, was told by Secretary Wallace today in a report responding to Senate and House resolutions." 
  4. ↑ Gompertz, John and Michael, Paul. "Nose Drop Contamination In Dropper Bottles" , JAMA (April 11, 1942).
  5. ↑ Rachael Bell. "The Tylenol Terrorist". TruTV Crime Library. http://www.trutv.com/library/crime/terrorists_spies/terrorists/tylenol_murders/index.html. 
  6. ↑ Bogdanich, W.; McLean, R. "Poisoned Toothpaste in Panama Is Believed to Be From China", New York Times, May 19, 2007.
  7. ↑ "China investigating toothpaste containing potentially deadly chemical". International Herald Tribune. 2007-05-22. http://www.iht.com/articles/ap/2007/05/22/asia/AS-GEN-China-Tainted-Toothpaste.php. 
  8. ↑ "U.S. checking all toothpaste imports from China". CNN. 2007-05-23. http://www.cnn.com/2007/HEALTH/05/23/china.toothpaste.reut/index.html. 
  9. ↑ China sentencia a muerte al exjefe de control de fármacos. (China sentences to death former drug control chief) La Nación, pp. 1 & 4. (May 30th 2007)
  10. ↑ US 'Self-contradictory' over Toothpaste Scandal , Embassy of the People's Republic of China in Negara Brunel Darussalam
  11. ↑ An Epidemiological Study on the Health Effects of Population Using the Toothpaste with Diethylene Glycol , Journal of Labour Medicine (China), vol.17, p 168-170, (2000)
  12. ↑ "7online.com: Toothpaste recall expands 6/18/07". http://abclocal.go.com/wabc/story?section=alerts_recalls&id=5399483. 
  13. ↑ "Toothpaste labeled Colgate recalled - More health news - nbcnews.com". http://www.nbcnews.com/id/19214360. 
  14. ↑ "Toxin found in fake UK toothpaste". BBC News. 2007-07-12. http://news.bbc.co.uk/1/hi/england/derbyshire/6896182.stm. 
  15. ↑ Walt Bogdanich (May 6, 2007). "From China to Panama, a Trail of Poisoned Medicine". New York Times. https://www.nytimes.com/2007/05/06/world/americas/06poison.html. "The syrupy poison, diethylene glycol, is an indispensable part of the modern world, an industrial solvent and prime ingredient in some antifreeze." 
  16. ↑ Walt Bogdanich (March 20, 2008). "Heparin Find May Point to Chinese Counterfeiting". New York Times. https://www.nytimes.com/2008/03/20/health/20heparin.html. "Federal drug regulators, in announcing Wednesday that the mystery contaminant in heparin was an inexpensive, unapproved ingredient altered to mimic the real thing, moved closer to concluding that Americans might be the latest victims of lethal Chinese drug counterfeiting." 
  17. ↑ Harris Gardiner (April 22, 2008). "U.S. Identifies Tainted Heparin in 11 Countries". New York Times. https://www.nytimes.com/2008/04/22/health/policy/22fda.html. "A contaminated blood thinner from China has been found in drug supplies in 11 countries, and federal officials said Monday they had discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the United States." 
  18. ↑ News.yahoo.com Nigeria child deaths from tainted syrup rise to 84
  19. ↑ "Contaminated medical marijuana believed to have killed cancer patient" , CBS News (February 7, 2017).
  20. ↑ "Valsartan: what caused the contamination? - ECA Academy". https://www.gmp-compliance.org/gmp-news/valsartan-what-caused-the-contamination. 
  21. ↑ Lowe, Derek (2019-01-04). "The Sartan Contamination Story" (in en-US). https://www.science.org/content/blog-post/sartan-contamination-story. 



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