Over the last few years, a scandal has been brewing, but it’s been out of sight to most people. Still, many healthcare providers and hundreds of patients have been aware of it or seriously affected by it.
The problem started in 2007 when the Food and Drug Administration started receiving an increasing number of reports of deaths in patients receiving the blood-thinning drug heparin.

Heparin is used when patients are going through procedures where blood clots might create life-threatening situations, such as cardiac surgery or kidney dialysis. It’s also used when blood clots are threatened. It is administered as an injection, but it is also present as a coating in some medical devices such as catheters, oxygenators, pumps, filters, and blood reservoirs used during cardiac procedures.

In all of 2006, there were 55 reports of deaths related to the administration of heparin. But between January 1, 2007, and May 31, 2008, there were 246 such reports. In fact, in one month, January 2008, there were 50 reported deaths. Many more reports of allergic reactions to the heparin were received.

After much examination and testing, the culprit turned out to be a contamination of heparin active ingredients manufactured in China. The contaminant proved to be extraordinarily elusive because it “mimics heparin activity” and so did not initially show up on routine testing.

Over the next two years, the FDA carried out investigations, issued warning letters and ordered broad heparin recalls. But by April 2010, the agency still had not determined exactly how the contamination occurred or who was at fault.

Finally, the U.S. Congress tired of the inefficiency of the FDA and slammed their failures in a letter dated April 30, 2010. The FDA was criticized for failing to adequately follow up on credible leads related to the contamination, failing to ensure correction of manufacturing practices in companies to which the contaminated heparin had been traced, failure to be effective in a health emergency and thereby costing lives. This strongly-worded, ten-page letter is available at:
http://republicans.energycommerce.house.gov/Media/file/News/043010_Letter_to_FDA_Heparin.pdf.
This Committee is now demanding answers from the FDA on why it handled the emergency in this fashion and how it plans to proceed from here.

While the entire matter of the heparin contamination is not yet resolved, it is good to see the U.S. Congress demanding effectiveness from the government agency that is responsible for protecting lives in just this situation.

Source: Food and Drug Administration, Information on Heparin, April 7, 2010, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInfor mationforPatientsandProviders/ucm112597.htm
Source: Food and Drug Administration, Update to Healthcare Facilities and Healthcare Professionals about Heparin and Heparin-containing Medical Products, April 30, 2009, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm135355.htm
Source: Food and Drug Administration, Information on Adverse Event Reports and Heparin, July 1, 2009,
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM112669 Source: Letter to FDA Commissioner Margaret Hamburg by the U.S. Congress Committee on Energy and Commerce, 30 April 2010,
http://republicans.energycommerce.house.gov/Media/file/News/043010_Letter_to_FDA_Heparin.pdf

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