Industry looks for end of Abbokinase shortage during FDA review

Abbott, FDA tying up loose ends

It’s been well over a month since Abbott Laboratories released any of its Abbokinase product, a thrombolytic agent with Food and Drug Administration (FDA)-approved indications for pulmonary embolism, coronary artery thrombosis, and IV catheter clearance. At press time, the FDA has yet to allow Abbott to begin shipping Abbokinase.

The problem results from an FDA inspection from Oct. 25, 1998, through Nov. 25, 1998. According to FDA spokeswoman Lenore Gelb, the main concern was Abbott "did not validate their viral inactivation. You have to be able to validate that the viral inactivation worked. That was one of the more major concerns we see."

Gelb tells Home Infusion Therapy Management the findings, which report 27 various deviations from Good Manufacturing Practices, do not mean Abbott failed to conduct such viral inactivation. The problem could lay in the lack of documentation, which the FDA wants to resolve.

"We have to have the paperwork to know that everything was done properly," says Gelb. "We’re working with the company, reviewing our inspectional finding, and want to make sure everything is safe."

Abbott spokeswoman Melissa Broats tells HITM the company is in contact with the FDA.

"We provided them with a response in late November, and have had an ongoing dialogue with them throughout December. . . . We are awaiting their response," she says. "At this time, they have not communicated any additional questions."

When asked whether the problems were due to a failure to conduct viral inactivation or required paperwork, Broats tells HITM, "I’m not going to be able to go into that much detail with you. I can say the process to make Abbokinase is the same process that we have used for the 20 years that we have been making it. It has provided a safe and effective product . . . and there are no reported cases of viral transmission. . . . We believe the lots being held are safe and effective as the previous [ones]

Neither the FDA nor Abbott could speculate when Abbott will be able to resume shipment. According to an FDA press release, none will be released until the FDA reviews the inspectional findings, as well as information later submitted by Abbott.

Until Abbokinase is readily available, the FDA holds there are alternative products available for certain situations. The FDA issued this list of thrombolytic products available in the United States, as well as their indications:

• Streptase (Hoechst Marion Roussel) — distributed by Astra USA
— Acute evolving transmural myocardial infarction
— Pulmonary embolism
— Deep vein thrombosis
— Arterial thrombosis or embolism
— Occlusion of arteriovenous cannulae

• Kabikinase (Pharmacia & Upjohn AB)
— Acute evolving transmural myocardial infarction
— Pulmonary embolism
— Deep vein thrombosis
— Arterial thrombosis or embolism

• Activase (Genentech)
— Acute myocardial infarction
— Acute ischemic stroke
— Pulmonary embolism

•Eminase (Wulfing Pharma GmbH) — distributed by Roberts Pharmaceutical
— Acute myocardial infarction

•Retavase (Centocor)
— Acute myocardial infarction.