Baxter supplier to be inspected

U.S. regulators haven't inspected a Chinese plant that was a source for the active ingredient in heparin, a blood thinner from Baxter International Inc. linked to life-threatening side effects.

Regulators don't know if the product from the Chinese supplier caused the serious side effects in patients who took Baxter's heparin, said Karen Riley, a Food and Drug Administration spokeswoman.

Doctors were urged by the FDA this week to limit use of the drug after reports of life- threatening reactions among those receiving it.

The FDA conducts annual inspections of about 7 percent of overseas drugmakers that ship to the U.S., a pattern suggesting it would take 13 years to visit them all, according to the Government Accountability Office, the investigative arm of Congress. Lawmakers have criticized the agency for failing to conduct more.

"While no FDA inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible," Riley said in a statement. "We have already requested expedited access to the facility, facilitated through a recently signed agreement with the Chinese State Food and Drug Administration."

Deerfield-based Baxter gets the active ingredient for heparin from a U.S. company that makes the product both in the U.S. and China, said Erin Gardiner, a spokeswoman for the company. She declined to identify the supplier. Baxter inspected the company's locations in the U.S. and China in 2007, Gardiner said.

The FDA warned of risks from Baxter's formulation of heparin after reports the blood pressure of some patients taking the drug dropped dangerously low. Other reactions included vomiting and difficulty breathing. Four patients have died after receiving injections of heparin, although the relationship to the drug is unclear, the agency said.