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FDA On The Hot Seat Over Heparin Horror

FDA On The Hot Seat Over Heparin Horror

Americans have been repeatedly told that we have the safest medicines in the world. That’s because the FDA has the reputation for policing our drug supply conscientiously.

The recent scandal over the anticoagulant heparin, however, has many people wondering just how safe our drugs really are.

Over the last several weeks, investigators have begun to piece together the puzzle. It all started when patients experienced severe allergic reactions to this injectable blood thinner: abdominal pain, nausea, vomiting, diarrhea, fever and low blood pressure. More than a dozen people have died.

Eventually, the problem was traced to China where the raw ingredients for heparin are produced from pig intestines. Early speculation attributed the problem to unsanitary manufacturing conditions or sick pigs.

Recent revelations, however, suggest that a contaminant was intentionally added to fool testers into thinking there was more heparin than was the case. This compound has been identified as over-sulfated chondroitin sulfate. Even though it hard to distinguish from heparin with basic tests, it has no anticoagulant activity.

This should ring some bells with alert readers who remember the pet food scandal from last year. Chinese suppliers added melamine to wheat gluten bought by American pet food manufacturers. Melamine was added to make the gluten appear to have more protein in it, so it could command a higher price. Dogs and cats died as a result of this adulteration.

Toxic toothpaste from China also had to be pulled off the market last year. It contained the poisonous antifreeze diethylene glycol that had been substituted for the more expensive ingredient, glycerin.

The heparin incident now looks like another instance of Chinese manufacturers charging more for less. The fact that the FDA had inspected the wrong Chinese plant adds to the calamity.

These incidents may be the tip of a giant iceberg. Over 500 factories in China export drug ingredients or finished pills to the United States. Last year, the FDA inspected 13.

Because of cutthroat competition, especially for generic drug ingredients, China and India have emerged as major suppliers. There is no system in place to insure that these products contain what they claim and nothing more. The heparin example demonstrates how vulnerable we are to counterfeit or adulterated medication.

Readers have reported failures and adverse effects from many generic drugs. Some may be related to imported ingredients. Others may be traced to shortfalls in FDA’s generic drug approval and monitoring process.

We recently warned about the special problems associated with some generic forms of the antidepressant Wellbutrin XL 300 and the heart and blood pressure pill Toprol XL. You can read more about this at this website,  www.peoplespharmacy.com.

Anyone who has had a problem with a generic drug can report to us or directly to the FDA at www.fda.gov/medwatch.

Physicians, pharmacists, insurance companies and hospitals have relied upon the FDA to guarantee that American medications are reliable and safe. They have assumed that the agency was capable of monitoring the drug supply chain. Perhaps it is time to reevaluate that assumption.


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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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