Unapproved Uses of Approved Drugs: The Physician, the Package Insert, and the Food and Drug Administration: Subject Review

PEDIATRICS ◽  
1996 ◽  
Vol 98 (1) ◽  
pp. 143-145 ◽  
Author(s):  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Age Groups ◽  
Package Insert ◽  
Age Group ◽  
Off Label Use ◽  
Off Label ◽  
Fda Approval ◽  
Approved Drugs

Physicians who prescribe a new drug that has not been approved for a specific indication or a specific age group frequently find themselves in a quandary. Physicians who prescribe "old," time-honored drugs usually do not consult the package insert or search for US Food and Drug Administration (FDA) approval. This statement was written to clarify the legal and informational status of the package insert and the role of the FDA in approving or not approving drugs for specific indications or specific age groups. The unapproved use of approved drugs, or so-called "off-label" use, is extremely prevalent among physicians who care for children. It is important that such use of compounds be brought up to date with current FDA policies and to emphasize the responsibility of the prescribing physician in the use of these compounds.

Unapproved Uses of Approved Drugs: The Physician, the Package Insert, and the FDA

PEDIATRICS ◽  
1978 ◽  
Vol 62 (2) ◽  
pp. 262-264
Keyword(s):  
Drug Administration ◽  
Age Groups ◽  
Package Insert ◽  
Age Group ◽  
Federal Law ◽  
Substantial Evidence ◽  
Specific Indication ◽  
New Drug ◽  
Approved Drugs

The physician who uses a new drug that has not been "approved" for a specific indication or a specific age group frequently finds himself in a quandary. The physician using an "old" and time-honored drug usually neither consults the package insert nor searches for U.S. Food and Drug Administration approval. This statement was written to clarify the legal and informational status of the package insert and the role of the FDA in "approving" or "not approving" drugs for specific indications or specific age groups. FDA and Federal Law Federal law requires that, before a new drug can be marketed in interstate commerce, it must be demonstrated safe and effective for its intended uses on the basis of substantial evidence submitted to the FDA.

Off-Label Use and Prescribing What Does It Mean for the Foot and Ankle Surgeon?

2010 ◽  
Vol 3 (5) ◽  
pp. 303-306
Author(s):  
Christopher F. Hyer
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Clinical Studies ◽  
Food And Drug Administration ◽  
Good Thing ◽  
Foot And Ankle ◽  
Off Label Use ◽  
Off Label ◽  
Practice Of Medicine ◽  
Indications For Use

Drugs and medical devices obtain specific on-label indications for use by the Food and Drug Administration. Physicians are able to use such devices and drugs off label as part of the practice of medicine, but is this is good thing? This edition of In the Profession examines what it means to be off label in terms of regulations, clinical studies, industry marketing, and common areas of use.

U.S. Food and Drug Administration and Off-Label Use of Expandable Metal Biliary Stents within the Peripheral Vasculature

2008 ◽  
Vol 19 (7) ◽  
pp. 965-969 ◽  
Author(s):  
Aron S. Yustein ◽  
Daniel Schultz ◽  
Carolyn Neuland ◽  
David S. Buckles ◽  
Joshua C. Nipper ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Off Label Use ◽  
Biliary Stents ◽  
Peripheral Vasculature ◽  
Off Label ◽  
Label Use

scholarly journals Cannabidiol in epilepsy: The indications and beyond

2020 ◽  
Vol 10 (6) ◽  
pp. 317-325
Author(s):  
Melody Ryan
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Dravet Syndrome ◽  
Off Label Use ◽  
Treatment Resistant ◽  
Childhood Onset ◽  
Off Label ◽  
Label Use

Abstract Epilepsy, although common, remains difficult to treat with as much as 30% of patients having treatment-resistant conditions. Lennox-Gastaut syndrome and Dravet syndrome are childhood-onset epilepsies and among the most difficult to treat. Cannabidiol has been approved by the Food and Drug Administration to treat these conditions in individuals over 2 years of age; however, there is a great deal of interest in off-label use. This article examines 3 cases: 1 of a patient with Lennox-Gastaut syndrome, 1 of off-label use of cannabidiol to treat epilepsy, and 1 of nonprescription forms of cannabidiol to treat epilepsy.

scholarly journals Seasonality in extra-pulmonary tuberculosis notifications in Germany 2004-2014- a time series analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tanja Charles ◽  
Matthias Eckardt ◽  
Basel Karo ◽  
Walter Haas ◽  
Stefan Kröger
Keyword(s):  
Time Series ◽  
Time Series Analysis ◽  
Disease Onset ◽  
Age Groups ◽  
Age Group ◽  
Pulmonary Tb ◽  
Series Analysis ◽  
Disease Site ◽  
Extra Pulmonary

Abstract Background Seasonality in tuberculosis (TB) has been found in different parts of the world, showing a peak in spring/summer and a trough in autumn/winter. The evidence is less clear which factors drive seasonality. It was our aim to identify and evaluate seasonality in the notifications of TB in Germany, additionally investigating the possible variance of seasonality by disease site, sex and age group. Methods We conducted an integer-valued time series analysis using national surveillance data. We analysed the reported monthly numbers of started treatments between 2004 and 2014 for all notified TB cases and stratified by disease site, sex and age group. Results We detected seasonality in the extra-pulmonary TB cases (N = 11,219), with peaks in late spring/summer and troughs in fall/winter. For all TB notifications together (N = 51,090) and for pulmonary TB only (N = 39,714) we did not find a distinct seasonality. Additional stratified analyses did not reveal any clear differences between age groups, the sexes, or between active and passive case finding. Conclusion We found seasonality in extra-pulmonary TB only, indicating that seasonality of disease onset might be specific to the disease site. This could point towards differences in disease progression between the different clinical disease manifestations. Sex appears not to be an important driver of seasonality, whereas the role of age remains unclear as this could not be sufficiently investigated.

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