August 30, 2019
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket Number 2019-14061
Dear Food and Drug Administration:
Benzodiazepine Information Coalition (BIC) is a 501(c)(3) nonprofit organization that brings together a network of medical professionals, patients, and other volunteers to educate a broad audience about the adverse effects of prescribed benzodiazepines (BZs) and Z-drugs. Our mission is to inform the general public, media, and medical professionals about the risks of these drug classes and the resulting epidemic of patient injury. We have reviewed your document entitled “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry,” and have the following comments:
First, we appreciate you taking the time to define the terms “abuse, misuse, addiction, dependence, and tolerance,” and are in agreement with how they are defined in the document. We also are pleased to see that you made further distinction between addiction and physical dependence, clarifying that they are “not synonymous.” These terms are often confused in clinical practice, to the detriment of the patient, as appropriate treatment plans differ between the two entities.
On this note, we recommend that in the section on physical dependence, it should be made clear that physical dependence can happen even when the medication is taken EXACTLY AS PRESCRIBED. We are aware of many patients who were shocked to find out they developed physical dependence on their benzodiazepine and/or Z-drug, because they were following their doctor’s orders, often only being warned about the risk of addiction when beginning the prescription, while the risks of physical dependence and adverse events were never properly explained.
In the section that recommends provision of “treatment and mitigation of dependence and withdrawal symptoms,” we believe this should be taken one step further. Detailed taper plans or links to tapering resources (such as “The Ashton Manual” for benzodiazepines) should be provided.
Benzodiazepine Information Coalition is dedicated to patient safety, physician education, full informed consent, and prevention of adverse events related to benzodiazepines. If we can be of further help, specifically on the future content in the benzodiazepine labels, please contact us at email@example.com.
Benzodiazepine Information Coalition