Challenges on off label medicine use

[Challenges on off label medicine use].

p After the Second World War, the so-called pharmacological explosion took place, leading to major advances in the treatment of diseases that were once inevitably fatal or disabling. This pharmacological expansion contributed to the occurrence of catastrophic incidents, such as the phocomelia epidemic attributed to thalidomide. Since then, concerns about drug safety have contributed to the deve...

Understanding off-label use and the new challenges

As there are several thousands of rare disorders and only some tents of orphan drugs authorized in Europe, off-label use of medicinal products occurs frequently in the diagnosis, prevention and treatment of rare diseases. Off-label use is the use of a medicinal product for another indication, another patient group, another dose or by another route of administration as indicated in the package i...

Off-label use of approved drugs: therapeutic opportunity and challenges.

In this issue of the JASN, Booth et al. (1) report a well-designed study using TNFblockade with infliximab (Remicade) to treat ANCA-associated systemic vasculitis. The use of infliximab, already approved by the US Food and Drug Administration (FDA) for treatment of inflammatory bowel disease, raises the general question of off-label uses of approved drugs. Clearly, off-label use of drugs by ind...

Off-label use of vaccines.

This article reviews the off-label recommendations and use of vaccines, and focuses on the differences between the labelled instructions on how to use the vaccine as approved by the regulatory authorities (or "label"1), and the recommendations for use issued by public health advisory bodies at national and international levels. Differences between public health recommendations and the product l...

Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union