Blood Thinning Drug Heparin Blamed for Infant Deaths, Complications

The popular blood-thinner Heparin, made by Baxter International Inc., was recalled in 2008 after it was discovered that a counterfeit active ingredient had been included in the drug by the Chinese manufacturing firm hired to produce Heparin. The tainted Heparin was blamed for at least 20 deaths and hundreds of injuries in patients who suffered severe reactions to the drug’s counterfeit active ingredient.

Heparin’s labeling also was blamed for deadly mix-ups in which pharmacy technicians, nurses, and other hospital personnel mistook full-dosed Heparin for HepLock, a weaker form of the blood thinner commonly used to treat infant patients. Heparin is about 1,000 times stronger than HepLock, so the mistakes caused fatal and life-threatening overdoses of the drug in at least a dozen hospitalized newborns.

One such high-profile case of confusion between Heparin and HepLock involved the newborn infant twins of Hollywood actor Dennis Quaid and his wife. The twins nearly died when they were accidentally given multiple doses of Heparin instead of HepLock while in Cedar-Sinai Medical Center in Los Angeles.

Contaminated Ingredient Found

The Food and Drug Administration started receiving reports of Heparin related injuries and deaths in January 2008. The agency alerted medical professionals and began an investigation to find the source of the problems. The FDA eventually traced the adverse reactions to the Chinese firm hired by Baxter to produce Heparin. It was learned that to cut costs, the Chinese company had substituted a fake ingredient for the real active ingredient in Heparin. The FDA later admitted the agency had violated its own policies by failing to periodically inspect the Chinese facility before and after approving the drug for sale in the United States.

Heparin Labeling Confusion Blamed for Injuries, Deaths

Confusing packaging and labeling on Heparin was blamed for several accidental overdoses of the drug in infants, some of whom died. HepLock is a diluted form of Heparin that is used to prevent blood clots from forming in the tiny intravenous lines of newborns and infants. However, the containers of full-strength Heparin and HepLock were similar enough in size, shape, color, and other details that mistakes were made. In some cases, multiple doses of full-strength Heparin were mistakenly given instead of HepLock, leading to severe injuries and death in infant patients.

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