2008-03-13T08:13:00.000-07:00

FDA investigators are trying to trace where the raw material for the blood thinner heparin leads. Heparin which is made from pig intestines is contaminated and an unyielding maze of slaughterhouses awaits the unknown American investigator.The president of the American company Scientific Protein Laboratories that owns a majority of the unregulated Chinese company claims that the collection chain for pig intestine suppliers is in place inspectors in China and the United States are not so sure.A pig disease swept over China depleting its stock of pigs. Some farmers sold their sick pigs for heparin production nevertheless. With no regulations and no rules including sanitation there is no foresight into the small village operations.The number of reports of heparin adverse reactions continues to rise and has surpassed 400. So far the authorities have not discovered the problem with the heparin supply chain and no firm findings have been announced.The heparin recall has directed focus on the quality of products from China and the gaps in regulation by both the Chinese and United States governments. Scientific Protein Laboratories’ plant in Changzhou was certified by American officials to export to the United States even though neither the Chinese government nor the American government ever inspected it since 2004.This company is not alone as many companies have fallen between the cracks because it is known as a producer of chemical ingredients not a drug manufacturer.The process of making heparin starts with the intestines of slaughtered pigs, from which the mucous membrane is collected and cooked, eventually producing a dry substance known as crude heparin.Major heparin producers like Scientific Protein Laboratories take that substance, refine it, and sell it to big pharmaceutical companies who make the final product, which is widely used in dialysis and CABG.Most of China’s crude heparin comes from small factories in poor villages where houses double as heparin mining. Working conditions are taxing, dilapidated, and a crap shoot.Source: http://www.nytimes.com/2008/02/28/world/asia/28drug.html?ref=us

March 14th. Latest on Baxter Recall

2008-03-13T06:39:00.001-07:00

Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products

Contact:
Erin Gardiner, (847) 948-4210
Deborah Spak, (847) 948-2349

FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., February 28, 2008 – Baxter International Inc. announced today that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.

The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.

Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the FDA and Baxter concluded that removing additional lots and doses of Baxter's heparin from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction. Accordingly, the FDA and Baxter decided not to recall all Baxter heparin vial products at that time. The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter's recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.

Although the vast majority of the reports of adverse reactions have been associated with the multi-dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter's recall will now include the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.

This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

"We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs," said Peter J. Arduini, president of Baxter's Medication Delivery business. "The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue."

Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.

Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives will be available twenty-four hours a day, seven days a week.

Baxter Heparin Recall

March 14th. Latest on Baxter Recall

Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products