FDA And Heparin
March 11th, 2008 | by askadmin |I write a lot about my lack of faith and distrust of both the pharmaceutical industry and of the FDA. I still have a port-a-cath, that was implanted during my chemotherapy. I have to have it flushed every four to six weeks. To do this the nurses use a blood thinner called Heparin.
Naturally when I came across an article in the Washington Post about the FDA in its plan to inspect a Chinese facility that supplies the active ingredient of Heparin, it caught my attention.
Here is the article:
According to the FDA, the Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected because the agency confused it with another plant that had the same name.
A team of FDA inspectors is now headed to China to inspect the correct plant, as part of an effort to determine what caused a sudden spike in serious reactions to heparin.
More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous drop in blood pressure, breathing difficulties, and vomiting. Four patients who took the drug died.
Federal law does not require inspections of foreign drug makers, although the agency will in most instances inspect before a new foreign drug or active drug ingredient is allowed in FDA-approved prescription medications. Such an inspection does not necessarily include an on-site visit if the company has passed previous inspections for other drugs.
I hope the problem has been resolved by now. I am scheduled to have my port-a-cath flushed tomorrow afternoon.
Read the entire article: