Government health officials are investigating if a Chinese factory may be a source of problems with a Baxter International blood thinner linked to hundreds of reports of allergic reactions and four deaths.
Baxter buys the active ingredient for the drug heparin from a supplier that manufactures it both at the Chinese factory and a facility in the U.S., Baxter spokeswoman Erin Gardiner said.
Baxter inspected both facilities last year and found no quality issues, Gardiner said. However, the company plans to reinspect the facilities "very soon" as part of its own investigation, she said.
The Food and Drug Administration, in a posting on its Web site, said it is "investigating all possible sources of the problem," including the Chinese plant and the New Jersey facility where Baxter finalizes production of the vials.
"We will be inspecting these facilities as soon as possible," the FDA document said.
FDA spokeswoman Karen Riley refused to confirm a report by The Wall Street Journal that the agency had never before inspected the Chinese facility, a longtime producer of the heparin ingredient.
Earlier this week, the FDA told doctors to switch from using Baxter's heparin, citing 350 reports of side effects so far this year. Four people died while taking the drug, although the agency said it wasn't clear if the heparin was to blame. In all of 2007, the FDA received 100 reports of problems with the drug.
Last month, Baxter had recalled nine lots of the injectable drug after learning of allergic reactions among dialysis patients, problems ranging from dizziness and fainting to a racing heartbeat. This week, Baxter said it would stop manufacturing multiple-dose vials while it and FDA attempted to locate the source of the problems.
Baxter accounts for about half the U.S. supply of heparin.