 |
 |

Warning on Abbokinase
JAMA. 1999;281:786.
 |
 |
| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
|
 |
 |
The FDA has issued an important drug warning to health care providers regarding the potential risks of transmitting infectious agents (including hepatitis C virus and HIV) associated with the use of the thrombolytic urokinase marketed by Abbott Laboratories as Abbokinase. During recent inspections of Abbott and its supplier of the cells used in the manufacture of Abbokinase, FDA identified numerous significant deviations from the current good manufacturing practice (CGMP) regulations. Accordingly, FDA recommends that currently available Abbokinase be reserved for only those situations in which a physician has considered the alternatives and has determined that the use of Abbokinase is critical to the care of a specific patient in a specific situation.
Because there currently may be a medical need for Abbokinase for the treatment of some patients and because of a shortage of the product, FDA concluded that it would not object at this time to Abbott's distribution of . . . [Full Text of this Article]
|