Abbokinase released to market
Product now has new warning label
With the Food and Drug Administration’s (FDA) release of Abbott Laboratories’ Abbokinase product to the market, the shortage is over. At the bottom of the pulling of the product apparently was the deviation from Good Manufacturing Practices (GMP), resulting in a new warning label for Abbokinase.
Lenore Gelb, FDA spokeswoman, says there were "collected deviations from the GMP," and the FDA will continue to review and monitor its progress.
The reason for the new warning label is simple.
"We wanted to make sure physicians knew everything about the risks [associated with the product], says Gelb. "They may decide then to make a different decision based on the risk and benefit of the product. We can’t quantify [the risk]. We can only say that we know there were manufacturing issues and the products were not screened properly. All biologics have some inherent risks. We’re not 100% sure we’ve identified all possible infectious agents."
For example, the new label, supplied to Home Infusion Therapy Management by Abbott, states the following:
• Warnings.
"Abbokinase is produced from cultures of primary human neonatal kidney cells. Products manufactured from human source materials have the potential to transmit infectious agents. Procedures to control such risks can reduce but cannot completely eliminate the risk of transmitting infectious agents. The procedures used in the manufacture of currently available Abbokinase raise concerns regarding the risk of transmission of infectious agents. In considering the risk, the prescriber should be aware of the following information regarding the available lots of Abbokinase:
Inadequate screening process?
"The kidney cells used in the manufacture of this product were obtained from populations at high risk for a variety of infectious diseases, including tropical diseases. Although efforts were made to screen and test the mothers and neonate donors, the screening and testing measures were inadequate and were not consistently or reliably performed.
"For example, the screening of potential donors did not include the questioning of the mothers to determine infectious disease status or specific risk factors for infectious disease, and donors were not tested for hepatitis C virus (HCV) infection. While Abbott has recently instituted a test for HCV in kidney cells used in the manufacture of currently available lots of Abbokinase, this test has not been validated. A viral inactivation procedure that has been shown to substantially inactivate HIV and HCV in other biological products was used in the production of the currently available product. However, this process has variable effects on other infectious agents and has not been validated for viral inactivation of Abbokinase."
Gelb notes the above "is not really a drug warning, per se. It’s an attempt to summarize our findings."
Melissa Broats, an Abbott spokeswoman, notes the company is "doing everything to improve and update manufacturing processes according to the areas identified by the FDA."
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