FDA urged to adopt warning labels for dangerous combination of medications
HARRISBURG, Pa. – The Pennsylvania Department of Health has announced it is joining city and state health directors from across the country in calling on the U.S. Food and Drug Administration (FDA) to adopt labels to explicitly warn about a dangerous combination of medications that is helping to drive the nation’s prescription drug overdose epidemic.
In a petition submitted to the FDA, health directors and commissioners from 13 cities and 17 states and territories called for a “black box warning” on opioids and benzodiazepines that states that concurrent use of both medications increases the risk of fatal overdose. Black box warnings appear on the labels of prescription drugs and call attention to serious or life-threatening risks.
“Seven people die each day from overdose in Pennsylvania; a tragic number that highlights the overdose epidemic we are currently battling,” said Secretary of Health Dr. Karen Murphy. “I signed this petition to help bring awareness to the very real and potentially lethal danger that exists when someone takes opioids and benzodiazepines at the same time. I join my colleagues from across the country in urging the FDA to take an important step in addressing this crisis by adding black box warnings to these types of prescriptions.”
A second petition, posted on Change.Org, can be signed by the public.
In addition to black box warnings, the petitions call for medication guides for both classes of medication to specifically warn patients about the risks of combined opioid and benzodiazepine use. Patients with chronic pain are often prescribed opioids to treat their pain and benzodiazepines to treat their associated symptoms, such as anxiety and sleep disorders.
In 2012, prescribers wrote 82.5 opioid prescriptions per 100 people and 37.6 benzodiazepine prescriptions per 100 people in the United States. Between 2000 and 2010, treatment admissions for co-occurring addiction to opioids and benzodiazepines increased by 569 percent. Evidence suggests that these two drugs interact in the brain and place patients at increased risk of respiratory depression and fatal overdose.
Every day in the United States, 44 people die as a result of prescription opioid overdose. In 2013, 22,767 people died of drug overdose deaths that involved prescription drugs. Approximately one in three unintentional overdose deaths from prescription opioids also involve benzodiazepines.
Learn more about the overdose crisis in Pennsylvania at www.ddap.pa.gov/overdose.
Proposed language for black box warnings:
• Labeling for all opioid class medications:
WARNING: CONCURRENT USE WITH BENZODIAZEPINES REDUCES THE MARGIN OF SAFETY FOR RESPIRATORY DEPRESSION AND CONTRIBUTES TO THE RISK OF FATAL OVERDOSE, PARTICULARLY IN THE SETTING OF MISUSE.
• Labeling for all benzodiazepine class medications:
WARNING: CONCURRENT USE WITH OPIOIDS REDUCES THE MARGIN OF SAFETY FOR RESPIRATORY DEPRESSION AND CONTRIBUTES TO THE RISK OF FATAL OVERDOSE, PARTICULARLY IN THE SETTING OF MISUSE.