Chinese Authorities To Become More Rigorous On Heparin Production

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Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals;  Litigation / Medical Malpractice
Article Date: 23 Mar 2008 - 12:00 PDT

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The SFDA (State Food and Drug Administration) of China says it is going to become much more stringent on heparin production methods. Heparin is a drug which thins the blood. Any oversight related to the production of heparin by manufacturers will be dealt with in a much tougher way, say authorities.

Heparin producers will only be able to obtain their ingredients from registered and approved sources, says the SFDA. Inspection procedures will also become much more demanding.

According to the US FDA, heparin production is now safe again. The FDA says it has identified the contaminant in the blood-thinning drug. The contaminant was over-sulfated chondroitin sulfate, which is virtually impossible to detect because it is so similar to heparin's active ingredient. The contaminant is suspected of being an international counterfeit, rather than the result of a manufacturing oversight. Chrondroitin sulfate is a cheap supplement which is a popular alternative therapy for arthritis.

Background

-- The US FDA (Food and Drug Administration) received reports of deaths linked to a raw Heparin ingredient imported from China, as well as hundreds of reports of serious injuries - approximately during late February/early March. The New York Times reported that some patients who received Heparin were experiencing breathing difficulties, vomiting, nausea, excessive sweating and serious drops in blood pressure - in some cases this led to life-threatening shock.

-- The FDA announced major recalls of the raw Heparin stock imported from China.

-- The FDA had failed to inspect Scientific Protein's plant in China, the American company. It should have been inspected before the drug was approved for sale. The FDA admitted this failure.

What is Heparin used for?

The drug is an anticoagulant, a naturally occurring one. It prevents the formation of blood clots, as well as stopping existing clots from extending. It does not break down existing blood clots. However, if a patient takes Heparin his/her natural clot lysis mechanism has a better chance of working normally and breaking down the clots.

Heparin is commonly used for patients with acute coronary syndrome (e.g. myocardial infarction), atrial fibrillation, DVT (deep vein thrombosis), pulmonary embolism. Also patients undergoing heart surgery are commonly given Heparin.

-- Heparin Investigation - Latest Baxter Update
-- Heparin - Evidence Points To Contaminant Source Earlier In Supply Chain
-- Heparin Contaminant Probably Counterfeit
-- FDA On Way To Setting Up Offices In China

Written by Christian Nordqvist
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