Heparin in the Top Ten

Los Angeles, CAOf all the medical mishaps and mistakes, recalls and reports of 2008, heparin contamination has to be in the top ten. The blood-thinning drug that was found to be tainted by it Chinese manufacturer allegedly caused hundreds of injuries and at least 20 deaths in the US and more than 80 serious adverse events in Germany. Add to that the Food and Drug Administration (FDA) report of 103 deaths following heparin's use, although all may not be directly linked to heparin.

It also sparked a furor from US critics with the FDA, claiming the agency was incapable of ensuring sufficient quality control to ensure drug safety and efficacy. However, one good thing came out of this mess: the FDA opened an office in Beijing, in order to tighten control and increase inspections. Let's hope it's not another "close the stable door after the horse has bolted" scenario…

In the wake of the heparin debacle, one would assume China's trade with the US would be damaged, or at the very least, tarnished. But it appeared to be 'business as usual': The most recent tampering includes the ever-present melamine, found in contaminated eggs, and of course the widespread milk contamination with melamine. (Perhaps the FDA hasn't sharpened their pencils at the Beijing office yet.)

And the top heparin story has to be Dennis Quaid and the heparin blunder at a Los Angeles hospital that almost killed his twin babies--staff at Cedars-Sinai Medical Center mistakenly gave then-newborns Thomas and Zoe a near-fatal amount of blood thinning drug Heparin--1,000 times the recommended dose of the blood thinner. (Heparin is used to flush out intravenous tubes and prevent blood clots. Babies typically receive 10 units of the drug.)

In December, 2008 the actor and his wife Kimberley were awarded $750,000 in damages. California regulators further fined the hospital administrators $25,000 after concluding that the staff at Cedars-Sinai Medical Center failed to follow their own procedures, which resulted in incorrect doses of the drug being administered to Quaid's infants and other children. Quaid said the error made the twins' blood the consistency of water.

The Quaids' also filed a lawsuit against Baxter, the maker of heparin, accusing executives of negligence in packaging adult and paediatric doses in similar vials. However, the suit has been dismissed on grounds of jurisdiction, because the incident occurred in California and the pharmaceutical firm's corporate address is listed in Illinois.

No doubt heparin will be in the news this year as numerous lawsuits against Baxter International are filed: by March 2008 the FDA received 785 reports of heparin complications. Even though the number of deaths is alarming, Baxter has only attributed a handful of those deaths to the use of its blood thinner.

The company recalled lots of heparin in February 2008 after the initial reports of allergic reactions, which include dizziness, nausea and trouble breathing. The FDA says most deaths involved one or more allergic symptoms or symptoms of hypotension.

FDA testing uncovered substantial quantities of a counterfeit chemical in the Baxter heparin, thought to be used for fraudulent reasons--the contaminated ingredient is a lot cheaper to produce than raw heparin. Although the fake ingredient accounted for between 5 percent and 20 percent of the total mass of each sample, the problems were not discovered by Baxter before they distributed the blood thinner throughout the US.

Regardless, the contaminated heparin should have been identified as subpotent by Baxter during its quality tests, which could have prevented countless injuries and at least 20 deaths.