If taken in too large of doses or in combination, the medications can cause “extreme sleepiness, respiratory depression, coma, and death”. Today’s actions are one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.
Advertisement
“We said, “we can not wait” and called upon the FDA to save lives now”, said Baltimore City Health Commissioner Dr. Leana Wen, who spoke to reporters on an FDA call about the announcement.
Healthcare professionals should reserve prescribing opioid pain medicines with benzodiazepines or other CNS depressants only for patients whom alternative options are inadequate.
When a patient gets his or her prescription filled now, the FDA says, the bottle should have a notification indicating a black-box warning for the drug.
More people died from prescription drug overdoses in 2014 than any other year on record, according to the Centers for Disease Control and Prevention.
Cough syrups made using the opioid codeine should also carry the government warnings.
The new warning requires changes in drug labeling to better inform patients and physicians on the risks associated with taking combinations of the drugs.
FDA officials said both types of drugs depress the central nervous system.
Some 70 different drugs, many of which are found in multiple products, will be carrying the new label information.
FDA is adding boxed warnings to labeling of benzodiazepines and prescription opioid pain and cough medicines.
The agency found that from 2004 to 2011, the rate of emergency department visits involving non-medical use of opioids and benzos increased significantly, with overdose deaths from taking prescribed or greater than prescribed doses almost tripling during that period.
According to the FDA, the number of people who were prescribed to use both benzodiazepines and opioid analgesics increased by as much as 41 percent from 2002 to 2014, resulting in an additional 2.5 million Americans taking the unsafe drug combination.
Deaths from opioid overdoses have hit an all-time record in the U.S.
The action by the FDA follows a U.S.
The move also came in response to a citizen’s petition presented to the FDA by a group of city and state health officials from around the country. Each class of drug is also widely abused.
Advertisement
Health care professionals and consumers are encouraged to report adverse events or side effects related to use of these products to the FDA. The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
