Heparin Contamination: What You Need to Know
Reports about contaminated supplies of the blood thinner heparin raise a number of big, unsettling questions about the global economy, the FDA's ability to police imports of drug ingredients and patient vulnerability.
Contaminated batches of the drug have been found in 10 countries and the U.S. Eighty-one deaths and perhaps hundreds of adverse reactions in the U.S. may be linked to the drug (although it hasn't been firmly established that the drug caused the deaths).
Three things you need to know:
1. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, says current supplies of the drug are safe. The heparin problems have been reported and studied since 2006, and safeguards have been put in place in the meantime, the agency says.
2. Could this kind of problem be stopped at the supplier level? A General Accounting Office report estimated that it would cost $67 million per year to inspect the 3,000-plus plants worldwide that supply drugs to the U.S. the FDA has $11 million budgeted for this purpose.
3. Can inspection and oversight systems be trusted, even if more money was spent? According to The Washington Post,"The FDA acknowledged last month that it had never inspected the plant because it confused it with another facility with a similar name, and Chinese officials said they did not inspect it because it was listed as a plant producing chemicals rather than pharmaceuticals." These facts make Woodcock's assurances of safety a bit harder to trust.
So is there anything you can do? If you're on heparin, you can consult with your doctor. But this particular problem has been the focus of attention for quite some time, and there is no red-light panic in the medical community. Most professionals believe the drug now in circulation is safe.
But the larger question--can the safety of U.S. drugs be guaranteed in an expanding global economy?--is likely to be with us for some time.
More questions? Read on for more information about heparin