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Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, email@example.com.
The US Food and Drug Administration recently revealed that the active ingredient used in the production of Baxter International Inc.'s recalled drug Heparin was made in a plant in China.
Rockville, MD (Feb. 19)-The US Food and Drug Administration recently revealed that the active ingredient used in the production of Baxter International’s recalled drug Heparin was made in a plant in China. FDA and Baxter are both stating that it is not known at this date what role the ingredient may or may not have played in the approximately 350 adverse reactions and four deaths possibly caused by the blood thinner.
The involvement of a Chinese factory in the production of a recalled drug raises the continued concern regarding Chinese-made products. According to the Wall Street Journal, China is the “world’s largest producer of active pharmaceutical ingredients.” The Chicago Tribune states that FDA is not required by law to inspect foreign manufacturing facilities but makes it a general rule to do so. FDA admitted it had not inspected the particular Chinese plant due to a mistake in paper work, but plans for the inspection of the plant are under way. The agency has requested that the facility provide inspectional data and adverse event reports regarding the possibly tainted drug. Critics say that the failure of FDA to inspect foreign manufacturing facilities continues to put consumers and patients at risk.
A Baxter spokesperson told the Wall Street Journal that the company has had a 20-year relationship with the supplier and that the supplier has made the specific active ingredient for 30 years. According to the spokesperson, no changes were recently made at the Chinese plant and it is unsure if there is any connection between the plant and the adverse drug effects.
Baxter temporarily halted production of heparin last week due to reports of four patient deaths and allergic reactions that included stomach pain, vomiting, low blood pressure, fast heart rate, and fainting. Baxter is a major producer of heparin, providing half of the nation’s supply. APP Pharmaceuticals (Schaumburg, Illinois) acquires the active ingredient for their heparin blood thinner from a Chinese plant as well but has, reportedly, not experienced the same kinds of adverse effects.