Four deaths may be caused by FDA’s negligence

U.S. health officials said Wednesday they have not inspected a Chinese factory that may be a source of problems with a blood thinner linked to allergic reactions and four deaths, but plan an inspection as soon as possible.

Photo: Four deaths may be caused by FDA’s negligence

The Baxter International blood thinner has been linked to hundreds of reports of allergic reactions and the four deaths. The Food and Drug Administration is investigating.

Baxter International Inc. is a global healthcare company with 48,000 employees and 2006 sales of US$10.4 billion. Its headquarters is in Deerfield, Illinois.

The company offers a diversified line of specialized medical products, generally categorized as BioScience, Medication Delivery. About 80% of its revenue comes from the U.S., Canada and Europe, with the rest primarily from Asia and Latin America.

The company has enjoyed strong growth through much of its history, and has been an innovator in many medically-related fields.

In 2004 Baxter announces the U.S. Food and Drug Administration's approval of Fluconazole, a generic formulation of a commonly used, intravenous anti-fungal, used in the treatment of serious fungal (Candida) infections.

In 2005 Baxter receives 510k clearance from the U.S. Food and Drug Administration to market its wireless pump connectivity interface that enables hospitals to connect Baxter's COLLEAGUE CX infusion pump to its Patient Care System.

Baxter and Cangene Corporation receive approval from the U.S. Food and Drug Administration for the liquid formulation of WinRho SDF.

Later that year Baxter receives approval from the U.S. Food and Drug Administration for GAMMAGARD Liquid 10% for patients with primary immunodeficiency disorders.