Shaheen Statement on New FDA Labeling Requirement for Opioid, Benzodiazepine Medications Aimed to Reverse Opioid Abuse Epidemic

(Manchester, NH) – U.S. Senator Jeanne Shaheen (D-NH) issued the following statement in reaction to the U.S. Food and Drug Administration’s (FDA) announcement that it is requiring class-wide changes to drug labeling to better inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and benzodiazepines, a class of commonly-used drugs prescribed to treat conditions such as anxiety, insomnia and seizure disorders. Today’s announcement will require pharmacies to put a boxed warning – the FDA’s strongest warning – on prescriptions of opioids analgesics, opioid-containing cough products and benzodiazepines, along with information about the serious risks associated with using these medications at the same time. This step is part of the FDA’s Opioids Action Plan, which focuses on policies aimed at reversing the opioid abuse epidemic.

“I have been a strong supporter of FDA action to help reduce the spread of opioid abuse, and I welcome today’s announcement of bold labeling so we can better inform doctors and patients and take the needed steps to curb the opioid epidemic,” said Senator Shaheen. “Across the Granite State and around the country, we are losing too many people to overdoses caused by opioids and a lethal combination of other commonly-prescribed drugs. We must do all we can to end the opioid epidemic and I support any effort to better inform consumers on the potential dangers of these drugs, including when combined with other medications.”

Senator Shaheen has been a leader in the Senate on efforts to combat the opioid epidemic. Last month, President Obama signed into law the Comprehensive Addiction and Recovery Act (CARA), co-sponsored by Senator Shaheen, which authorizes support for treatment providers and law enforcement’s efforts to combat drug trafficking, though it does not provide funding for these programs. Shaheen has continued to lead the effort in Congress to pass emergency supplemental funding for those on the frontlines of the opioid addiction crisis. Her legislation would provide supplemental appropriations totaling $600 million to programs at the Department of Justice and the Department of Health and Human Services that focus on treatment and recovery, as well as state and local law enforcement initiatives.