The FDA says it never inspected the Chinese plant that makes Baxter Healthcare’s heparin- the same anticoagulant drug that is currently being pulled off the market because of a mysterious contamination that is linked to four deaths and hundreds of illnesses.
The Chinese facility makes the active ingredient for heparin, though Baxter would not name the facility.
"While no FDA inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible," the FDA 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."
Baxter says it did inspect the facility within the last six months.
The quality of imports from China have been under intense scrutiny since revelations that many toys made there have contained lead paint and pet foods were made with unsafe and toxic ingredients.
China is the world’s largest maker of pharmaceutical ingredients, even though the FDA has reportedly had difficulty monitoring the quality of the products. The agency only does direct inspection on about seven percent of foreign drug-making facilities.
In recent testimony to the General Accounting Office the FDA admitted it, “cannot provide the exact number of foreign establishments that have never been inspected.”
The Wall Street Journal reports that in 2005, China has $4.4 billion in sales of active drug ingredients.
Ever since the first of the year, the FDA reported it’s received about 350 reports of allergic reactions to Baxter’s injectable heparin. There were only 100 reports in all of 2007.
Reactions to heparin, made from pig intestines, included vomiting and diarrhea, low blood pressure, fainting and speeding heartbeats.
Heparin is widely used in emergency rooms, dialysis facilities and critical care areas as a preventive to blood clots. Baxter makes about half of all multi-dosage vials of heparin. Millions get the drug every year.
Baxter reportedly buys the active ingredient for heparin from a U.S. supplier then has the Chinese factory and another facility in New Jersey that turns it into the drug. Baxter refused to identify the supplier but does say they’ve worked with them for 20 years and the supplier has made the heparin ingredient for three decades.
The New Jersey plant will be investigated as well.
On January 25th- Baxter recalled nine lots of heparin blood thinner after some dialysis patients experienced allergic reactions.
Then on February 11th, Baxter suspended the multi-dose heparin vial production while the company and FDA tried to troubleshoot after four patients undergoing kidney dialysis and heart surgery had a fatal reaction.
Doctors have been told to switch to another manufacturer. APP Pharmaceuticals Inc. of Schaumburg, Illinois makes about half of the U.S. supply of heparin. It too manufacturers the drug in China but has not had these problems.
Baxter has made heparin since 2002 and it brings in about $29 million in annual revenue for Baxter-about one percent of the company's total revenue. The drug has been sold in this country since the 1930s. It is given either directly by injection or intravenously to prevent clotting. #