Healthedia.com: Who is Responsible for Monitoring China’s Raw Heparin Quality?

When complaints surfaced in the United States from patients suffering serious complications after receiving the blood-thinning drug heparin, investigations began to determine whether the raw material used for the drug had been contaminated. The raw material is made from pig intestines in slaughterhouses in China.

After the reports of injuries, and even some deaths, sales of multidose vials of the drugs were halted by Baxter International. Recent blog posts discuss who, if anyone, is taking responsibility to make sure standards are met.

Men’s Health Today recently confirmed that “tainted supplies of the blood-thinning drug heparin have been traced to China.” At the time of the post, there had been 350 adverse reactions and four deaths. To make matters worse, the post notes that when the FDA went to inspect the Chinese plant that makes the active ingredient, they “confused the name of the plant with another plant…this highlighted the U.S. government’s inability to monitor where our medicine comes from—something the Government Accountability Office has raised a red flag about.”

In a recent post, Wall Street Journal’s Health Blog reported that China put the responsibility back on the U.S. to make sure standards are adequate. “If the U.S. is concerned about the quality of raw heparin imported from China, the Americans need to make sure the proper controls are in place, China’s State Food and Drug Administration said today,” relates the post. The Chinese FDA states that it works with “foreign regulators” to monitor their factories, however ultimately, the importing nation must make the assurances for itself.

China’s FDA also noted that “Chinese producers of active pharmaceutical ingredients must be drug companies that are ‘registered and certified’ by the Chinese FDA,” and a spokeswoman from the agency said foreign buyers need to confirm this certification and “make strict tests” on ingredients. However, “the company that sold the raw heparin used by Baxter wasn’t certified by the Chinese FDA because it was registered as a chemical company, not a drug company.”

The supplier of heparin in the U.S., Baxter International, has been under fire lately for other reasons as well. Not only did they have to recall the drug due the injuries and deaths caused by the contaminated raw materials, they are being sued by Dennis and Kimberly Quaid according to ParentDish. Many dosage mix-ups have occurred because “the packaging of Heparin in the 10-units-per-milliliter vial and the 10,000-units-per-milliliter are virtually identical.” The Quaids assert the company had previous knowledge of these mix-ups, “yet did not recall shipments of the drug or properly warn hospitals of the dangers,” states the post.

About Healthedia

Healthedia is your guide to the best Health and Wellness blogs, podcasts and videos available on the Internet. Because our focus is on expert health social media we aggregate and organize content from the largest group of doctor blogs of any site on the Internet. Together with Nutritionists, Dieticians, Chiropractors, Physiotherapists, Diet Counselors, Fitness Instructors, Naturopaths, Herbalists, Disease Specialists and other professionals, Healthedia provides you with unparalleled access to the highest quality advice, commentary and opinion available on the Internet today. Please visit Healthedia.com