Baxter Healthcare Heparin crisis grows - active ingredient traced to Chinese production plant that was not inspected by the FDA

Deerfield, Illinois-based Baxter Healthcare

Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ML 10 and 30mL Multi-Dose Vials
NDC NUMBERS 0641-2440-45, 0641-2440-41, 0641-2450-45 and 0641-2450-41; LOTS: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111

January 25, 2008 – Baxter Healthcare Corporation has announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Baxter is conducting a thorough investigation of these reports to identify the cause of the increase in allergic-type reactions.

Heparin, (Baxter Data Sheet)which has been in widespread clinical use since the 1930s, is administered in operating rooms and other critical care areas to prevent blood clots and is crucial in hemodialysis and heart surgery, it is derived from pigs intestines although was first extracted from livers (hepar =Gk liver) . Millions of patients worldwide each year receive the product intravenously and Baxter sells 100,000 vials a day.

The company sells about $30 million of heparin injections annually, compared with $11.2 billion in corporate sales in 2007.

Baxter suspends multi-dose heparin vial production Guradian / Reuters Monday February 11 2008 By Susan Kelly

CHICAGO, Feb 11 (Reuters) - Baxter International Inc on Monday said it has temporarily stopped making the blood-thinner heparin in multi-dose vials after four patients who took the drug died and hundreds of others became ill.

The U.S. Food and Drug Administration said it had received about 350 reports of health problems associated with Baxter's injectable heparin product since the end of 2007. Four patients died, but the relationship to the drug is unclear, an FDA statement said.

Since the recall, Baxter has received reports of similar adverse reactions occurring in other lots of 1,000 units/mL, 10 and 30mL multi-dose vials; 5,000 units/mL and 10,000 units/mL multi-dose vials; and 5,000 units/mL single-dose vials when single doses were combined to create a larger bolus dose.

FDA Never Inspected Chinese Facililty Where Ingredient in Heparin Is Made
By Anna Wilde Mathews and Thomas M. Burton WSJ 13th february 2007

A Chinese facility that has never been inspected by the U.S. Food and Drug Administration made the active ingredient of a Baxter International Inc. blood-thinner that is under investigation after reports of hundreds of allergic reactions and four deaths among its users, the agency said yesterday.

An FDA spokeswoman said the plant making the active ingredient for the drug heparin "was supposed to be inspected" but "due to human error, and inadequate information-technology systems, a pre-approval inspection, which would normally be conducted, was not." Currently, she said, "preparations are being made to perform an inspection as soon as possible."

Both the FDA and Baxter have specified that it is not clear the allergic reactions are linked to the product from the Chinese facility.

Market watch Feb 13th
Baxter heparin ingredient made in uninspected plant: report By Wallace Witkowski

SAN FRANCISCO (MarketWatch) -- Active ingredients used in the recently recalled blood thinner heparin made by Baxter International Inc. have been traced back to a Chinese plant that had never been inspected by the Food and Drug Administration. In January, Baxter issued an "urgent" recall of batches of heparin after reports it caused severe allergic reactions in hundreds of recipients that included four deaths.

The Chicago Tribune report that Baxter's Heparin is manufactured at a plant in Cherry Hill, N.J. where the product is finished, (and is currently stopped) the Deerfield-based company uses a U.S. based-supplier that makes the "active pharmaceutical ingredient" in plants in China. Baxter would not name the supplier.

The U.S. Food and Drug Administration could not be reached for comment.."We have worked with this supplier for over 20 years and we have been making Heparin for over 30 years," said Baxter spokeswoman Erin Gardiner.

UPDATE : 14th February 6.15 EST.

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Abortion Pill maker Revealed CBS Shanghai-based Hua Lian Pharmaceutical Co. will make the raw compound for RU-486, but the FDA refused at the time to discuss the manufacturing arrangement for RU-486. Hua Lian got help from the U.S.-based Rockefeller Foundation in winning the production license for RU-486 under FDA specifications, said Gao Ersheng, a research director at the Shanghai Family Planning Commission.

A statement from Danco said the plant that will make RU-486 for the U.S. market meets "both Danco's drug specifications and the current good manufacturing practices of the FDA."

Danco Laboratories is an LLC which was incorporated in the Cayman Islands in 1995. Danco has a license from the Population Council to distribute the drug mifepristone, under the brand name Mifeprex. Mifeprex is the only drug distributed by Danco. The offices of Danco are in New York City, and are under an unlisted phone number and a post office box for security purposes.

There are many who will query the concern that the FDA have that production facilities of RU-486 meet current good manufacturing practices of the FDA yet there are problems over Heparin used daily by haemodialysis patients.