In a drug safety communication on September 23, 2020 titled FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class (here), the FDA announced changes being made to the boxed warning on all benzodiazepine products. The communication describes the need for the change as follows: “[T]o address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions, the U.S. Food and Drug Administration (FDA) is requiring the Boxed Warning be updated for all benzodiazepine medicines.” The notice addresses FDA reasoning and provides information for consumers as well as for healthcare practitioners.
It appears from the tone of the communication and the Agency statement, “[P]ostmarketing data suggest that benzodiazepine abuse and misuse are common and that associated harms are substantial but occur primarily when people use benzodiazepines in combination with other drugs,” that the Agency is becoming more concerned about the abuse potential of this class of drug.
Opioids were the first class of abuseable drugs that received significant publicity, and the opioid epidemic is still raging across the country. The Agency has attempted to address the opioid problem by encouraging manufacturers to develop abuse-deterrent formations of such products. The success of those efforts appears to be somewhat limited, and recently a “panel of government health advisers say there’s no clear evidence that a harder-to-crush version of the painkiller OxyContin, designed to discourage abuse, actually resulted in fewer overdoses or deaths”(here and here). However, the FDA has not been deterred (no pun intended) from pursuing the path to abuse-deterrent formulation of opioid products.
In our previous posts (here and here), we hinted to the potential for the Agency to attempt to pressure firms into developing abuse-deterrent formulations for other drugs of abuse, such as amphetamines and benzodiazepines. The continued and heightened concern about abuse of the benzodiazepines makes them clearly a target for such action. Whether the Agency will ultimately follow the path it took for opioids is currently a matter of mere speculation. However, each step towards stronger product warnings and increases seen in abuse clearly raises the specter of additional FDA scrutiny and a potential for the expansion of abuse-deterrent options for other products with abuse potential.
Clearly, the goal of developing abuse-deterrent formulations is worthy, but only if they actually ultimately reduce abuse. Taking this path for other products with abuse potential will increase the costs to consumers and insurance companies as newly designed products which replace older, less expensive versions is always worrisome for access to all who need them. But do not be surprised if there eventually becomes a creep of abuse-deterrent formulations into other products with abuse potential.
