PROBLEM
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The FDA has reported that up to 21 deaths and 448 allergic reactions may be linked to the blood thinning product heparin..
One million doses are sold very month. The drug is most commonly used to prevent blood clots in patients undergoing kidney dialysis Heparin has been sold and used in the U.S. since the 1930’s to prevent blood clots from occurring in patients.
Patients were seen having severe reactions to the drug Heparin. Reactions included vomiting, dropping blood pressure to the point where they can go into shock,
The use of the Baxter produces half of the heparin sold in the United States. Baxter makes roughly half of the United States supply of heparin, used widely for surgical and dialysis patients
On 2/11/08 Baxter HealthCare Corp. announced that it would stop producing the blood thinner after numerous reports of serious allergic reactions and patient deaths.
THE FDA
The FDA has reportedly received more than 350 complaints regarding health problems that have been associated with the heparin medication in recent years. These problems seem to be most prevalent in patients who were undergoing kidney dialysis and heart surgery.
The FDA said that the problem was first reported to the U.S. Centers for Disease Control and Prevention (CDC) in January. Most of the allergic reactions occurred in dialysis centers, and in patients receiving a high dose of heparin in a short period of time. Currently, the cause of the allergic reactions is still unknown despite finding chondroitn recently as filler in the heparin..
THE CHINA PROBLEM
China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration.
China has never given authority for the FDA to inspect their factories and the FDA never felt it was necessary because China was not a drug manufacturer but only a producer of chemical ingredients
However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency’s jurisdiction.
SOURCES OF HEPARIN
The raw material for heparin comes from the mucous membrane of pig intestines. It is collected, cooked, and dried to create heparin, which is filled in vials and sold to Baxter labs.
A factory in China gets the raw material from 2 wholesaler and they have 12 suppliers. Blue ear pig disease recently infected the pigs, and depleted the raw material stock. The suppliers were forced to get 70% of their raw material from small village factories that slaughtered sick pigs. Many family style barrels stored enzymes, and resins of the pig intestines in wastewater. The villages accepted low prices and the suppliers bought the material. Neither certification nor inspection was necessary.
Later, suppliers were forced to use sheep intestines because of continued pig shortages. We stopped using sheep in the U.S. because of acrapies in the sheep that could be transferred to humans causing mad cow encephalitis.
After the FDA sent inspectors to evaluate the Chinese facilities it reported on March 19, 2008, that heparin sold by Baxter was contaminated with condroitin sulfate, a compound less expensive to manufacture than heparin. Heparin was diluted with 50% of this filler, which acted as a blood thinner but was much cheaper to manufacture. Whether this was the problem causing the deadly reactions is still not known.
GOVERNMENT ACTON HAS BEEN TAKEN
In December, American and Chinese regulators signed an agreement under which China promised to begin registering at least some of the thousands of chemical companies that sell drug ingredients. Some of these companies are the source of counterfeit or diluted drugs, including those used to treat malaria.
Discussions that led to the accord began after an unlicensed chemical plant in China made a tainted drug ingredient that poisoned more than 170 people in Panama, killing at least 115.
Congress has criticized the oversight by the Food and Drug Administration of bulk pharmaceutical ingredients made by foreign manufacturers and sold in the United States. A growing number of those ingredients now come from China. Of the 700 approved Chinese drug plants, the United States agency has inspected only 10 to 20 each year. And heart surgery. Since the end of December, there have been about 350 reports of adverse reactions associated with Baxter's heparin product.
WHAT TO DO NOW
Authorities are urging doctors to use non-Baxter vials of heparin. Baxter sells roughly half the heparin sold in the U.S. and has agreed to halt making heparin products associated with the reported adverse effects
One wonders about other drug ingredients shipped by China in the manufacture of our drugs. Will other blood thinners as Warfarin also known under the brand names of Coumadin, Jantoven, Marevan, and Waran) be checked also?
ACTION IS BEING TAKEN
The death toll is up to 81 in the U.S. Eleven countries have now reported adverse reactions. After an inspection, unclean tanks were noted and raw materials arrived from unacceptable vendors. There appears to be no adequate way to remove the impurities. Still the origin of the source of contamination is unknown. Deaths occured only in the U.S. It seems our american doctors use large amounts of heparin in infusions and give the heparin quickly.
The FDA has set up 3 inspection centers in China but have not got Chinese approval yet to be there. It will take 15 million dollars more to inspect the Chinese drug plants every two years as they are inspected in the US. The FDA says it needs 56 million more dollars to inspect foreign plants. It would take 13 years to check every foreign drug plant and 1900 years to check every foreign food plant.
Where would the money come from? The domestic and foreign markets would be charged fees to pay for these inspections.
There is much concern about the safety of our Chinese imports. First there was poisonous toothpaste, then lead tainted toys, toxic pet food, tainted fish, and now contaminated medicine.
Where does it end? The rest of the story is still untold. Stay tuned.
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