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3/25/1999

Update on FDA Warning on the Use of Abbokinase

ASHP posted, on February 26, 1999, information about the FDA's warning on the use of Abbokinase. It noted that the FDA's January 25, 1999, Dear Healthcare Provider letter was applicable to all currently available lots. The FDA posted on March 16, 1999, an Update on Abbokinase that describes Abbott's actions to resolve good manufacturing deficiencies. Also on March 16, 1999, Abbott sent a "Dear Abbokinase Customer" message by Western Union Mailgram. Subsequently, the FDA posted on March 22, 1999, a repeat of the March 16 update, annotating that Abbott had sent the "Dear Abbokinase Customer" message and that the FDA had reviewed it and issued a Warning Letter to Abbott. The FDA stated that the Abbott message constitutes labeling and that it violates applicable law and regulations by failing to include approved product labeling and includes representations and suggestions that are false or misleading.

The apparent consequence of the FDA warning letter to Abbott is the continued applicability of the FDA's January 25, 1999, Important Drug Warning letter to all currently available lots of Abbokinase.

The FDA documents referenced can be found on the FDA's web site at:

  • December 11, 1998, Difficulties in Obtaining Sufficient Amounts of Urokinase (Abbokinase?)—http://www.fda.gov/cber/infosheets/abb121198.htm   
  • January 25, 1999, Important Drug Warning letter—http://www.fda.gov/cber/ltr/abb012599.htm   
  • March 16, 1999, Update—http://www.fda.gov/cber/infosheets/abb031699.htm   
  • March 22, 1999, Update—http://www.fda.gov/cber/infosheets/abb032299.htm   
  • March 19, 1999, Warning Letter to Abbott—http://www.fda.gov/cber/ltr/abb031999.pdf 

    Other related article: 

  • FDA warns about clot buster (Heart Information Network)

    ASHP posted a related article in July.

    Questions and comments may be addressed to Joseph H. Deffenbaugh at jdeffenb@ashp.org or (301) 657-3000, Ext 1250.