Heparin: A Long List of Reported Problems

Rockville, MDIt sounds like a long list of serious issues concerning one drug: counterfeit ingredients, unsanitary manufacturing plants, severe allergic reactions, improper labeling and accidental infant overdoses. Yet all of these complaints have been alleged against heparin, a drug that was supposed to make things easier on patients, not harder. Heparin syringes were allegedly contaminated, both by counterfeit ingredients and by debris from an unsanitary manufacturing facility, causing some patients to experience a severe heparin reaction.

In the situations involving contaminated heparin, the problem was not with the drug itself so much as with how it was manufactured. In one case, the heparin was manufactured with over sulfated chondroitin sulfate, an ingredient meant to mimic heparin, but that was not actually heparin. In another case, the problem was that a manufacturing plant was so unsanitary that debris wound up in the heparin vials.

As far as is known, all lots of the contaminated heparin have been recalled, and the heparin that is currently available is safe. But the damage to consumer confidence has been done. Patients, and loved ones whose family members died after heparin exposure, are left wondering how it is possible that such deadly products could have ever been used on patients.

News that the US Food and Drug Administration (FDA) did not inspect a new heparin manufacturing plant in China before approving it as a heparin supplier has not done much to ease consumer fears. That plant, in Changzhou, is alleged to have supplied the counterfeit heparin that was linked to numerous deaths.

The heparin contamination scares have been serious enough that some patients say they told their medical professionals not to give them the drug, but were still exposed to it. Rachelle H (real name withheld) went into the hospital and says she was given a heparin IV against her wishes.

"When my stomach started having sharp pains, I immediately questioned the nurse and asked her if she had put Heparin in my IV drip," Rachelle writes. "She declined to answer and when I had to get out of bed to go to the bathroom I immediately noticed the Heparin bag on my IV pole. I demanded that they take me off Heparin but med with heavy resistance. The only way I got away from the medication was to get discharged from the hospital. Since then I have constant stomach bleed outs and have had to take a combination of Zegerid and Sucralfate to relieve the symptoms."

Heparin also made the news after actor Dennis Quaid's twins were reportedly given massive overdoses of the drug. He filed a lawsuit against the makers of the drug after his two babies were accidentally given 1,000 times the prescribed dose of the drug. Luckily both infants recovered.