Baxter, FDA trapped in horror story over mysterious heparin quality blunders

by Anne Law, February 15th, 2008, 6:50 am

The tale begins with pharmaceutical maker Baxter International’s January recall of nine batches of its heparin drug after reports of possible adverse reactions, including four deaths. Baxter is responsible for half of the country’s supply of heparin, a blood thinner considered essential in certain medical procedures.

And so this week, as the reports widened beyond the recalled lots, the company halted production of the drug until it and the FDA could determine the root cause, although Baxter will continue to distribute already-produced lots of heparin to avoid a shortage. On Thursday, the plot thickened when it was discovered that a key source for the active ingredient in Baxter’s heparin was a manufacturing plant in China that had somehow missed its scheduled FDA inspection.

While the investigation hasn’t found that the contamination originated at the plant, the discovery adds an extra twist to the heparin problem and also points to the already scandalized lack of FDA oversight of pharmaceuticals imported from other countries. (Of course, the problems widely reported in China have also recently spread to pharmaceutical manufacturing operations in Puerto Rico.)

We all know that China is having quality control issues within its booming manufacturing industries, and we also know that the FDA is overworked and understaffed when it comes to monitoring the wide variety of sources from which the US population gets its never-ending supply of pharmaceuticals. What we don’t know is how long it will take for the sluggish heparin investigation to reach its denouement, or, for that matter, for drug oversight to improve as a whole.

This recent scandal could cause repercussions down the line if Baxter’s stockpile runs out or is ultimately deemed unusable before a conclusion is reached. Another major supplier, APP Pharmaceuticals, is ramping up production of heparin, but overall the steps being taken may not be enough to stem a possible shortage of the drug, which is widely used in kidney dialysis and heart surgeries.