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US doctors say drug labels lack key information

22-Oct-2009

Related topics: Packaging

Drug labelling approved by the US FDA often lack key information, according to two physicians quoted in the New England Journal of Medicine (NEJM).

Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, New Hampshire wrote that “Much critical information that the Food and Drug Administration(FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.”

The also say that although the US “federal stimulus package included $1.1 billion to support comparative-effectiveness research” no money has been allocated to “disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs.”

They cite two sleep drugs, Sepracor’s Lunesta and Takeda’s Rozerem, as examples of products where effectiveness information possessed by the FDA has been omitted from informations labels.

The full “Lost in Transmission — FDA Drug Information That Never Reaches Clinicians” article is available here .