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Rep. Barton Questions FDA Investigation of Heparin

By Beth Janicek

The controversy surrounding the drug Heparin has been unfolding over the past year with reports of drug recalls and deaths and injuries as a result of contaminated Heparin. It appears, however, that some of the reports the public has been receiving contains conflicting information.

The Food and Drug Administration (FDA) began their investigation this year after news of patients having allergic reactions to Heparin. In May, the FDA contributed three deaths to the drug. In December, three officials from the FDA reported in the New England Journal of Medicine that there have been no deaths resulting from Heparin. This is puzzling because in October the FDA sent a letter to Representative Joe Barton of Texas stating that of 16 deaths involving heparin they investigated, the FDA found heparin to be the “possible” cause of death in three cases and the “probable” cause of death in one case.

As a result of this conflicting information, Rep. Barton sent a request to the Government Accountability Office (GAO) asking them to review the FDA’s handling of the heparin issue. In his letter Rep. Barton also points out that the FDA linked one of their “probable” heparin related deaths to drugs made by the American Pharmaceutical Partners APP company, but the APP drugs were never implicated in the heparin recall and the companies own investigation found no links from the heparin they manufactured to the deaths reported. For more details, a copy of Rep. Barton’s letter to the FDA can be found here.

In the end we have medical journals, pharmaceutical companies, and the FDA giving conflicting information about Heparin and the risks it poses to patients. The public deserves clear answers and thorough investigations when it comes to potentially deadly drugs. Maybe Rep. Barton’s letter will initiate some discovery into the truth on Heparin.

Originally posted at InjuryBoard by Beth Janicek

Full post as published by San Antonio Personal Injury Lawyer on January 06, 2009 (boomark / email).