FDA Requires Boxed Warnings On Danger Of Opioid, Benzodiazepine Combined Use

WASHINGTON-The Food and Drug Administration, concerned about death and overdose risks from narcotic painkillers taken with certain antianxiety or sedative drugs, on Wednesday issued its most serious safety warning about the drug combinations.

FDA is requiring boxed warnings - its strongest warning - and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines, that is, a group of almost 400 products in total.

Facing a massive uptick in fatal overdoses caused by the dual use of, the FDA announced yesterday that it would demand that pharmaceutical companies begin issuing "boxed warnings" -the strongest FDA warning- on almost 400 drugs warning of the danger of the two classes of drugs taken at the same time.

Boxed warning labels on opioids and benzodiazepines will need to explain the danger of using the drugs with one another following a decade of increased prescribing of both classes of drugs and a rise in overdose deaths from using them together. Benzodiazepines are prescribed for the treatment of anxiety, insomnia and seizure disorders, and the drugs in this class include such commercial names as Xanax and Ativan.

"We know approximately half of concurrent benzodiazepine and opioid analgesic prescriptions were dispensed to patients on the same day and prescribed by the same health care provider", Throckmorton said. After taking an in-depth look at how these drugs and other medications affect the body when taken at the same time, the Food and Drug Administration has issued a "black box warning" on almost 400 products.

The FDA's announcement is in lockstep with the U.S. Centers for Disease Control, which has similar clinic guidelines.

The CDC estimates that almost 15,000 people in the United States die every year of overdoses involving prescription painkillers.

Health officials are warnings doctors and patients about the potentially fatal consequences of mixing prescription painkillers and popular sedatives like Valium and Xanax, which can lead to breathing problems, coma and death.

The FDA on Wednesday stopped short of requiring a new black box warning on drugs such as methadone used to wean people addicted to opioids from those drugs. The move comes following criticism that it has not done enough to stem the rising tide of the opioid crisis.

FDA cited increases in prescriptions of both types of drugs as a major factor.

According to the NBC, the FDA has been heavily criticized for not acting quickly nor doing something effective to stop overuse and abuse of opioids. FDA is also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available.

Heroin addicts frequently overdose in Camden and dealers play with formulas and mix components that depress people's respiratory system or worse.

The warning has come at a time when the use of such medications is increase.

Doctors routinely prescribe benzodiazepines along with opioids, unaware of the potential overdose risk, Wen said.

  • Joanne Flowers