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Thursday
Mar 06

Poor quality Heparin causes Adverse Reports

The Chinese plant that supplies most of the blood thinner, Heparin used in the United States has been in the middle of a controversy ever since it was established that the number of deaths related to the drug has gone up. According to the Food and Drug Administration, the problems with the drug were mainly procedural but they could not yet hold anything responsible for ‘serious side effects.’

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The Chinese plant that supplies most of the blood thinner, Heparin used in the United States has been in the middle of a controversy ever since it was established that the number of deaths related to the drug has gone up. According to the Food and Drug Administration, the problems with the drug were mainly procedural but they could not yet hold anything responsible for ‘serious side effects.’

Baxter International, the company in question, makes Heparin from pig intestines which, of course, could be supplied by U.S. farmers. The supplies are bought from a Chinese plant, which was found to have problems with the quality and use of its equipment and overall quality control.

"We're still considering all possibilities," said Food and Drug Administration compliance Chief Deborah Autor. "We have not ruled anything out at this point."

The production at Baxter International was brought to a close earlier this month, after reports of deaths and many allergic reactions, including vomiting, nausea and difficulty breathing, surfaced.

Besides the Chinese plant, Changzhou SPL, FDA is also conducting investigations at two Chinese wholesalers that supplied crude heparin to the former.

Heparin is used to avoid the formation of blood clots in blood vessels. Large doses of the drug are used in heart surgeries and during dialysis.

Baxter International, on Thursday recalled virtually all of its remaining heparin products. Initially, the step was not taken so as to prevent the shortage of the product in hospitals.

The FDA asserted that the current findings are preliminary and must be further investigated. China isn't the only focus of investigation; the FDA also is conducting check ups at facilities in the U.S.

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