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New Study Finds 1 In 5 Serious FDA Recalls Don’t Reach Doctors or Public

June 5, 2012 by The Parrish Law Firm

A new study has found that while the U.S Food and Drug Administration (FDA) announces recalls for possibly harmful medications about once a month, its communication of those recalls to doctors and patients needs improving, reports Reuters Health.

Researchers found that over an eight-year time period, the FDA sent only 4/5 of their most important recalls through its two electronic systems that alert both doctors and the public about the recalls, meaning the one out of every five serious recalls never reaches doctors and patients.

Class I recalls are issued for drugs that can cause “serious adverse health consequences or death,” says the FDA. The 2008 recall of heparin, a contaminated blood thinner that resulted in multiple deaths, was a Class I recall and was reported, according to the study.

Between 2004 and 2011, the FDA sent out 91 Class I recalls, but only 55 of those were announced through the Recall Alert System that notifies subscribers of the possible dangers of the drug. Another 18 notifications were sent through MedWatch, leaving 18 Class I recalls unannounced.

In a letter to the Archives of Internal Medicine, the authors of the study wrote that “despite recent efforts by the FDA to address the drug recall burden, health care providers may be inadequately informed about clinically important recalls that threaten patient safety,

A spokesperson for the FDA was unable to say why notifications were not sent out for 18 Class I recalls.

If you have been harmed by a defective drug in Northern Virginia, you need the veteran lawyers at Parrish Law Firm, PLLC to protect your rights as a consumer. Please call us today at 703-906-4229, or contact us via email for a free case consultation.

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