Heparin: Tainted Product, Confusing Labels and the Hollywood Factor

Hollywood, CAIn the spring it was poisoned pet food, then tainted toothpaste. In the summer and fall, lead-laced toys for tots. Now, the latest word that appears to summarize problems with imports from China, is heparin.

Heparin is a blood thinner made from the intestines of pigs, and in the last several weeks heparin has been all over the news. In December of last year the US Food and Drug Administration (FDA) announced an alert regarding the emergence of Serratia marcescens, a bacterium that can cause serious injury or death. A number of blood infections had been reported.

Then in January, the FDA announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT Inc., of Angier N.C. Two lots of the product were found to be potentially contaminated with Serratia marcescens. The recall applies to all prefilled heparin and saline flush syringes made by AM2 PAT.

Then it was Baxter International weighing into the fray, with a recall that was later expanded to include virtually all of its heparin product due to concern that production problems at a plant owned by one of its suppliers, Wisconsin-based Scientific Protein Laboratories in China, together with a concern over the quality of raw heparin from un-regulated processing houses in China, was allowing an unknown contaminate into the heparin that was making people ill. The FDA has received hundreds of reports of allergic reactions to heparin, and dozens of reports of deaths, which may have been linked to potentially tainted heparin. Baxter International, it should be noted, states that in their view the number of deaths potentially attributable to tainted heparin is more correctly placed at four.

Nonetheless, there is cause for concern, made all the more palpable by similar allergic reactions and adverse effects reported recently in Germany.

And now comes the revelation that an unknown substance has been found in heparin originating from China. Thanks to sophisticated testing which the FDA hopes is adopted by other authorities, it has been determined that as much as 20 percent of the active ingredient in some lots of heparin originating from China contain a counterfeit substance which serves to mimic the effect of heparin, but is not heparin.

What that substance is, has not been determined. However, it does appear reminiscent of past scandals, where ethylene glycol (anti-freeze) was substituted for medical-grade glycerin in toothpaste, and toxic melamine (plastics) was put into pet food to mimic protein.

An outbreak of pig disease last year throughout many provinces in China depleted stocks, and drove up prices of raw heparin.

And now, a recent lawsuit by actor Dennis Quaid is shedding light on a labeling issue connected with Baxter International-issued heparin that may have put the lives of the Quaid children in jeopardy.

ABC News reported that the newborn twins of Quaid and his wife Kimberly Buffington were treated for a staph infection at Cedars Sinai in Los Angeles late last year, and were mistakenly administered a potentially lethal dose of heparin.

Doctors had intended that the twins be given a 10-unit dose of heplock, a diluted version of heparin. However, given that the bottles allegedly share a remarkable similarity, the twins were instead given 10,000 units.

Last year, the same mistake was made with three premature babies at an Indianapolis hospital. The dose proved lethal, and the three babies did not survive.

Luckily, Thomas Boone and Zoe Grace, the twin children of Quaid and Buffington, survived. After a terrifying ordeal during which it was reported the twins fought for their lives, legal counsel for the Hollywood couple report that the twins are now doing well.

However, Quaid is concerned about the packaging, which potentially contributed to the mix-up. Bottles of 10-unit heplock, and 10,000-unit heparin have the exact same shape and size, with similar blue labels. Shown on camera on the ABC new program Good Morning America, the hemlock vial presents a label that's baby blue in color, whereas the more potent heparin vial presented dark blue.

It is been reported that Quaid is suing Baxter Healthcare Corporation for more than $50,000.

For its part Baxter reportedly issued a safety alert to health care professionals after the three baby deaths in Indianapolis, but the labels allegedly remained unchanged.

"The lawsuit is not about money," Quid's attorney Susan Loggans said, appearing on Good Morning America in December.

"This lawsuit is about the Quaids not wanting this to happen to another baby."