1941 — Sulfathiazole Winthrop Poisoning (tablets contaminated with phenobarbital) — >82

–Hundreds. Deaths and injuries. J. P. Swann (FDA Historian’s Office).[1]

—<300  Deaths and injuries. FDA. A History of the FDA and Drug Regulation in the U. S.

—  300  Williams (ed.). Endotoxins: Pyrogens, LAL Testing and Depyrogenation.[2]

—  >82  Greenberg, Michael I.  Disasters: Terrorist, Natural and Man-Made. 2006, p. 58.

 

Kentucky

–1  Louisville. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7.

 

Louisiana

–1  New Orleans. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, 7.

 

Massachusetts

–1  Worcester. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7.

 

Missouri

–1  Farmington. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p.7.

 

Nebraska

–1  Lincoln. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7.

 

North Carolina

–1  Edenton. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7.

 

Pennsylvania

–1  Allentown. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7.

–1  Clearfield. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7.

–1  Norristown. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p.7.

–1  Palmerton. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7.

–1  Philadelphia. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, 7.

 

Texas

–1  Tyler. INS. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7.

 

Narrative Information

 

FDA: “1941. Nearly 300 deaths and injuries result from the use of sulfathiazole tablets, an antibiotic, tainted with the sedative phenobarbital. In response, the FDA drastically changes manufacturing and quality controls…” (FDA. A History of the FDA and Drug Regulation in the United States. FDFA 1906-2006 Centennial Website, 5 pages.)

 

Greenberg: “1940-1941: USA

“At least 82 people died from the therapeutic use of sulfathiazole that had been contaminated with phenobarbital. The contamination was attributed to an error during the tabletting process.”

 

Swann: “The beginning of modern standards for good manufacturing practices can be traced to an incident that began in December 1940, when the Winthrop Chemical Company of New York put on the market sulfathiazole tablets contaminated with phenobarbital. Hundreds of deaths and injuries resulted. FDA’s investigation into Winthrop’s sulfathiazole production and the agency’s efforts to retrieve the Winthrop drug remaining on the market revealed numerous control deficiencies in the plant and serious irregularities in the firm’s attempt to recall the tainted tablets. The incident prompted FDA to require detailed controls in sulfathiazole production at Winthrop and throughout the industry, an approach that became the basis for production control standards for all pharmaceuticals.”

 

Williams: “1941. Sulfathiazole tainted with phenobarbital; 300 died due to ineffective recall efforts by Winthrop. One lot contained on average 0 mg of sulfathiazole and 350 mg of phenobarbital; 100-150 mg dose being hypnotic.” (Williams (ed.). Endotoxins: Pyrogens, LAL Testing and Depyrogenation. P. 11.)

 

Newspapers

 

March 29: “Chicago, March 29-(AP)-Hundreds of Federal inspectors, aided by physicians, were engaged today in tracking down 419,000 medicinal tablets which, the American Medical association said, had been contaminated in manufacture. The association disclosed that phenobarbital, a powerful sedative drug, had been inadvertently used in the manufacture of the tables, which were issued by a New York drug firm as sulphathiazole. Sulphathiazole, a derivative of the sulfanilamide, is used in the treatment of pneumonia and certain infections….

 

“Dr. Morris Fishbein, editor of the AMA Journal, issued a statement to physicians and druggists to be on the lookout for the adulterated drug which could be distinguished by the lot number MP 029. It was distributed by the Winthrop Chemical company of New York, Dr. Fishbein said.

 

“The first information that the drug was contaminated came from Farmington, Mo., Dr. Fishbein stated, and the U.S. Food and Drug administration immediately sent hundreds of inspectors throughout the nation to recover as much of the drug as possible. ‘Records already available from Missouri and Kentucky indicate a considerable number of patients who received this product suffered severe narcosis, but practically all recovered without ill effects,’ Dr. Fishbein said. ‘Records also indicate the possibility that patients with pneumonia who received this drug died. Rapid loss of consciousness in patients receiving sulfathiazole should indicate need for prompt determination of the nature of the product administered.’….” (Assoc. Press. “Inspectors Seek To Track Down Contaminated Tablets.” Northwest Arkansas Times, 3-29-1941, p. 1.)

 

March 31: “Washington, March 31.–(AP)–Walter G. Campbell, food and drug commissioner, appealing to physicians to watch for contaminated sulfathiazole tablets, said today that incomplete reports showed five deaths had occurred in cases in which he said the tablets were used. He added, however, that pending further investigation it could not be definitely determined that the contaminated drug alone was responsible for the deaths. ‘More or less serious untoward effects’ were reported in ‘some hundred cases.’

 

“‘The failure of the responsible officials of the Winthrop Chemical CO. [Rensselaer, N.Y., manufacturer of the tablets] to notify the Food and Drug Administration immediately of the incident has as yet not been satisfactorily explained,’ Campbell said.” (Associated Press. “Doctors Asked To Watch For Contaminated Pills.” The Titusville Herald, PA, 4-1-1941, p. 1.)

 

April 2: “Chicago, April 2 (AP).–The American Medical association reported today the recovery of 280,000 of approximately 386,000 tablets of sulfathiazole which had been inadvertently contaminated with phenobarbital, a powerful sedative….” (Associated Press. “Many Tablets Are Recovered.” The Port Arthur News, TX, 4-2-1941, p. 20.)

 

April 7: “Chicago, April 7.–(INS)–Seventeen deaths have occurred after use of contaminated sulfathiazole tablets, the Journal of the American Medical association reported tonight. The tables, contaminated with phenobarbital in such a way as to produce coma-like sleep and sometimes death, were released by mistake from a New York drug manufacturing plant, and frantic efforts on a nationwide scale have been made to recall them.

 

“The deaths, which the Journal said ‘may have been attributable’ to the contaminated drug, occurred at Allentown, Pa., Lincoln, Neb., Farmington, Mo., Norristown, Pa., Worcester, Mass., Palmerton, Pa., Edenton, N.C., New Orleans, Louisville, Ky., Philadelphia, Tyler, Tex., and Clearfield, Pa.” (International News Service. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7.)

 

Sources

 

Associated Press. “Doctors Asked To Watch For Contaminated Pills.” The Titusville Herald, PA, 4-1-1941, p. 1. Accessed 11-4-2017 at: https://newspaperarchive.com/titusville-herald-apr-01-1941-p-1/

 

Associated Press. “Inspectors Seek To Track Down Contaminated Tablets.” Northwest Arkansas Times, 3-29-1941, p. 1. Accessed 11-4-2017 at: https://newspaperarchive.com/northwest-arkansas-times-mar-29-1941-p-1/

 

Associated Press. “Many Tablets Are Recovered.” The Port Arthur News, TX, 4-2-1941, p. 20. Accessed 11-4-2017 at: https://newspaperarchive.com/port-arthur-news-apr-02-1941-p-20/

 

FDA (U.S. Food and Drug Administration). A History of the FDA and Drug Regulation in the United States. FDA 1906-2006 Centennial Website, 5 pages. Accessed 11-4-2017 at: https://www.fda.gov/downloads/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandingover-the-countermedicines/ucm093550.pdf

 

Greenberg, Michael I.  Disasters: Terrorist, Natural and Man-Made. Sudbury, MA: Jones and Bartlett Publishers, 2006.

 

International News Service. “17 Deaths Are Blamed on Contaminated Tablets.” The Charleston Gazette, 4-8-1941, p. 7. Accessed 11-4-2017 at: https://newspaperarchive.com/charleston-gazette-apr-08-1941-p-7/

 

Swann, J. P. “The 1941 Sulfathiazole Disaster and the Birth of Good Manufacturing Practices.” PDA [Parenteral Drug Association] Journal of Pharmaceutical Science and Technology, Vol. 53, No. 3, May-June 1999, pp. 148-53. Abstract accessed 11-4-2017 at: https://www.ncbi.nlm.nih.gov/pubmed/10754705

 

Williams, Kevin L. (Ed.). Endotoxins: Pyrogens, LAL Testing and Depyrogenation (Third Edition). New York and London: Informa healthcare. Boca Raton, FL: CRC Press, 2007. Google digital preview accessed 11-4-2017 at: https://books.google.com/books?id=7q7im7Rjvu4C&printsec=frontcover#v=onepage&q&f=false

 

 

[1] Swann, J. P. “The 1941 Sulfathiazole Disaster and the Birth of Good Manufacturing Practices.” PDA [Parenteral Drug Association] Journal of Pharmaceutical Science and Technology, Vol. 53, No. 3, May-June 1999, pp. 148-53.

[2] We do not use as fatality estimate in that (1) we speculate that the source being drawn from is one which notes 300 deaths and injuries, and (2) nice round numbers should raise a red flag.