On 2017 Jun 16, David Keller commented:

To the Editor: The study by Eguale and colleagues [1] demonstrates that off-label use of prescription drugs is associated with increased ADEs (adverse drug events) only when such use lacks strong scientific evidence. Specifically, off-label uses of drugs with strong scientific evidence had the same risk of ADEs as on-label use. This finding implies that the extreme expense and delay caused by the process of U.S. Food and Drug Administration (FDA) approval of an already-approved drug for a new indication may not be necessary if strong scientific evidence supports such use. The take-home message of this study is not that we need to crack down on off-label prescribing, but that we need to crack down on unscientific prescribing.[2] Electronic health records should be programmed to discourage unscientific prescribing, not off-label prescribing. Because off-label prescriptions backed by strong evidence are just as safe as prescriptions for FDA-approved indications, the FDA ban on promotion of the former denies patients the benefits of safe and scientifically proven medications. The focus should shift to suppression of off-label prescribing only when it is not backed by strong evidence.

Conflict of Interest Disclosures: None reported.

References

1: Eguale T, Buckeridge DL, Verma A, et al. Association of off-label drug use and adverse drug events in an adult population. JAMA Intern Med. 2016;176(1):55-63.PubMedArticle

2: Good CB, Gellad WF. Off-label drug use and adverse drug events: turning up the heat on off-label prescribing. JAMA Intern Med. 2016;176(1):63-64.PubMedArticle

On 2017 Jun 16, David Keller commented:

To the Editor: The study by Eguale and colleagues [1] demonstrates that off-label use of prescription drugs is associated with increased ADEs (adverse drug events) only when such use lacks strong scientific evidence. Specifically, off-label uses of drugs with strong scientific evidence had the same risk of ADEs as on-label use. This finding implies that the extreme expense and delay caused by the process of U.S. Food and Drug Administration (FDA) approval of an already-approved drug for a new indication may not be necessary if strong scientific evidence supports such use. The take-home message of this study is not that we need to crack down on off-label prescribing, but that we need to crack down on unscientific prescribing.[2] Electronic health records should be programmed to discourage unscientific prescribing, not off-label prescribing. Because off-label prescriptions backed by strong evidence are just as safe as prescriptions for FDA-approved indications, the FDA ban on promotion of the former denies patients the benefits of safe and scientifically proven medications. The focus should shift to suppression of off-label prescribing only when it is not backed by strong evidence.

Conflict of Interest Disclosures: None reported.

References

1: Eguale T, Buckeridge DL, Verma A, et al. Association of off-label drug use and adverse drug events in an adult population. JAMA Intern Med. 2016;176(1):55-63.PubMedArticle

2: Good CB, Gellad WF. Off-label drug use and adverse drug events: turning up the heat on off-label prescribing. JAMA Intern Med. 2016;176(1):63-64.PubMedArticle