WASHINGTON -- Consumer advocates urged the government today to immediately recall a clot-busting drug called Abbokinase because it could be contaminated with such infections as hepatitis.
The Food and Drug Administration already has warned of the potential infection risk. Last month, the agency urged doctors to use the numerous other clot-busters sold instead, and to consider Abbokinase a last resort.
The FDA had suspended sales of Abbokinase in November to investigate whether there were safety violations in manufacturing. But extensive sampling of suspect Abbokinase failed to prove any vials actually are contaminated. Although that's not an absolute guarantee, the FDA let sales resume late last month once manufacturer Abbott Inc. had upgraded its safety methods to guard against future problems.
The consumer group Public Citizen charged today that FDA ignored its own inspectors' recommendations to seize $100 million worth of Abbokinase and the raw materials used to make it -- kidney cells from dead babies imported from Colombia.
Sales of the drug were estimated at $200 million a year.
The group called for an FDA investigation into the "extremely suspicious circumstances" in which Maryland-based BioWhittaker Inc. obtained the kidney tissue it sold to Abbott. Inspection reports say the tissue was obtained without proper screening to ensure the babies and their mothers were healthy.
Also, the group urged FDA to consider whether charges should be brought against the importer for bringing human body parts into the country without labeling them potentially infectious, required for proper Customs scrutiny.
"Abbott and the FDA are making a travesty of public health" by letting Abbokinase sell with a warning label that says there's no guarantee it's safe, Wolfe wrote.
"We are comfortable with our approach," responded FDA biological products expert Dr. David Feigal.
Abbott and BioWhittaker apparently followed certain safety standards deemed proper when the drug was first approved in 1978 -- not modern standards that FDA now requires, which include proper testing of newborns and their mothers to make sure neonatal tissue harbors no infections, Feigal said. Abbott has, however, upgraded to solve that problem, he said.
He added that for further reassurance, Abbokinase is heat-pasteurized, which can kill many infections.
Abbokinase breaks up blood clots in legs and lungs, and clears catheters used by extremely sick patients. There are numerous other alternatives that work equally well or better but are much safer, so recalling Abbokinase won't hurt patients, Wolfe said.
But some doctors insist Abbokinase works best in certain serious or life-threatening situations, Feigal said. So FDA concluded that if those doctors understand the potential infection risk, they can choose it.
"Some doctors feel it's lifesaving, others feel they can use alternatives successfully. We're not trying to second-guess that, just to make sure people understand this is a product that might have some risks," Feigal said.
As for Wolfe's complaint that Abbokinase sells even though its own label warns it can't be guaranteed infection-free, Feigal said FDA is about to put similar warnings on blood-derived drugs and other products made from human body parts.