Adderall Injury and the FDA

In February 2005, Health Canada (the Canadian equivalent to the FDA) suspended sales of Adderall in Canada.

However, in the United States, the FDA chose to march to the beat of the pharmaceutical lobbyist drums. The FDA did not feel that any immediate changes were warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada’s analyses of adverse event reports and FDA’s own knowledge and assessment of the reports received by the agency.

Instead the FDA chose the path of least effectiveness and issued a Public Health Advisory and listed information sheets on its website at www.fda.gov in order to address questions that would arise from the Canadian announcement and to provide up-to-date information about Adderall’s safety profile.

The FDA also stated that as with any drug, the FDA will continue to carefully assess any new data that emerges which significantly affects the safety profile of this drug and will take immediate, appropriate action to promote the public health and make the public aware of its findings.

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Fast forward to August 2006 and 1.5 years have passed where millions of children and adults have taken Adderall creating billions of profitable dollars for GlaxoSmithKline and Shire Plc. Finally 18 months later, big pharma decides to strengthened warnings that the attention-deficit drug, Adderall (which Health Canada suspended sales for in February 2005) may cause psychological side effects and that misuse may lead to sudden death from heart attacks and strokes.

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