Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Services 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T99-32 Print Media: 301-827-6242 July 16, 1999 Consumer Inquiries: 888-INFO-FDA
Abbokinase is derived from cultures of human kidney cells from newborns who have died of natural causes, and is approved in the United States to dissolve blood clots in the lungs and heart arteries. It is also approved to help clear intravenous catheters.
During inspections of Abbott Laboratories and of BioWittaker, Inc., Abbott's supplier of human kidney cells, FDA identified numerous significant deviations from current good manufacturing practice (CGMP) regulations designed to assure product safety.
Compliance with CGMP is important because products manufactured from human sources have the potential to transmit infectious agents. CGMP for products such as Abbokinase requires important, overlapping safeguards in the production process, including adequate
These recent findings of contamination and Abbott's inability to locate the source of the problem have raised further concerns at FDA about Abbott's entire manufacturing process for Abbokinase. Abbott's deviations from CGMP could significantly impact the safety of the product. One FDA concern is that deficiencies in manufacturing practices could also lead to the product being contaminated with microorganisms that have not yet been detected.
In January 1999, FDA issued a letter to health care providers in order to alert them to important safety information regarding the use of Abbokinase. The letter included information about the potential risks of the product for transmitting infectious agents. It also recommended that Abbokinase be reserved for only those situations where a physician has considered the other available treatment alternatives and has determined that the use of Abbokinase is critical to the care of a specific patient in a specific situation. In addition, at FDA's request, Abbott changed the labeling of the product to include additional information to reflect these safety concerns so that physicians would have a clear understanding of the risks of using Abbokinase.
However, since the January letter to health care providers, FDA obtained additional information regarding the inadequacy of the screening and testing of the mothers and donors of the human kidney cells used to produce Abbokinase. Information was also obtained regarding the seven instances of in-process lots of product being contaminated with reovirus and mycoplasma.
In the letter to Abbott, the agency has detailed the steps Abbott needs to take to correct the serious and significant manufacturing deviations. These include:
The actual risk to patients of developing an infectious disease as a result of using Abbokinase is unknown.
Patients should discuss any concerns they may have about prior use of Abbokinase with their physicians.
Physicians should continue to report any adverse events, including infections that may be attributable to Abbokinase. These reports can be made to Abbott Laboratories, Pharmaceutical Products Division, North Chicago, Il. at 1-800-633-9110 or the FDA via the Medwatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or via the Medwatch website at www.fda.gov/medwatch/.