How amytal changed psychopharmacy: off-label uses of sodium amytal (1920-40).

In the early 1930s, American neurologist and psychiatrist William Bleckwenn used sodium amytal to render catatonic patients responsive, so that he could engage in talk therapy. Bleckwenn found a new, 'off-label' use for this anaesthetic and anxiolytic medication in psychiatry and, in doing so, allowed for important discoveries in the diagnosis and treatment of catatonia. Pharmacological textbooks reveal a 'label', while the Index-Catalogue of the Library of the Surgeon-General's Office reveals explorations 'off label' of barbiturates. The 'off-label' use of barbiturates facilitated talk therapy, heralding an important shift in psychopharmacy. Drugs previously only used as chemical restraints became a form of treatment for specific psychiatric diseases. The current strictures against off-label prescribing are overprescriptive and close off innovative new uses.

Off-label prescriptions in diabetic foot / Prescrições off-label em pé diabético

Prescription of a drug outside of the indications for which it was originally approved by regulators is internationally known as "off-label" prescription. We describe off-label treatments for the diabetic foot reported in international scientific literature. This is a qualitative and descriptive bibliographical review based on the results of a search of the Medline international database. The criteria for review were publication between January 1985 and November 2013, and the MeSH (Medical Subject Heading) keywords "off-label use" OR "off-label" OR "off-label prescribing" plus "diabetic foot" were input on the search form. Nine studies were selected that contained information about off-label treatments for the diabetic foot. We conclude that the practice of off-label prescribing has potential benefits. In some situations an off-label prescription is the only treatment available for patients, either because a more targeted drug does not exist, or because other methods of treatment are ineffective or unavailable due to patient intolerance...

A prescrição de um medicamento sem as indicações para as quais a droga foi originalmente aprovada por órgãos reguladores é internacionalmente conhecida como prescrição off-label. Descrevemos a terapia off-label em pé diabético, relatada na literatura científica internacional, por meio de uma revisão bibliográfica qualitativa, descritiva, através de pesquisa na base de dados internacional Medline, para seleção dos artigos. Os critérios para revisão foram publicações entre janeiro de 1985 e novembro de 2013, sendo as palavras-chave MeSH "off-label use" OR "off-label" OR "off-label prescribing" plus "diabetic foot" – colocadas no formulário de busca. Foram selecionados nove artigos com informações sobre a terapia off-label em pé diabético. Conclui-se que a prática de prescrição off-label possui benefícios potenciais em muitas situações. Em algumas circunstâncias, uma prescrição off-label é o único tratamento disponível, seja por não existir uma droga específica, seja porque outros métodos de tratamento são ineficazes ou não disponíveis por intolerância...

Criminalizing knowledge: the perverse implications of the intended use regulations of off-label promotion prosecutions.

Your company has spent months designing a compliance program and training your sales representatives. They know never to mention the off-label uses of your product. If they are asked about the off-label uses by the physician they are detailing, they know to forward those inquiries to the scientific liaisons at headquarters. But, could your company still be in legal jeopardy simply because it knows that the product is being used for an off-label purpose? This article attempts to track the Food and Drug Administration's (FDA's) shifting interpretation of its "intended use" regulations, from focusing entirely on the statements of the manufacturers to focusing on the knowledge of the industry, indeed, of the consumers of products, in determining the true intended use of a product. It will look at several recent attempts by FDA to use that new interpretation of the regulations to expand its power: to regulate tobacco and to require pediatric indications for any new drug. Finally, it will look at several recent examples of how this new interpretation has manifested in actions by FDA and the Department of Justice (DOJ).