FDA planning to add new boxed warning to all immediate-release opioid painkillers
As part of a multipronged government campaign aimed at reversing an epidemic of abuse and death linked to drugs such as Vicodin and Percocet, federal health regulators are planning to bolster caution labels on the most commonly used prescription painkillers.
On Tuesday, the Food and Drug Administration (FDA) shared plans of addition of a new boxed warning, most severe kind of warning, to all immediate-release opioid painkillers, like combination pills that contain oxycodone and nonprescription drug ingredients.
In the US, the drugs, sold as Vicodin and a number of generic brands, have been among the most prescribed drugs. They accounted for over 135 million prescriptions in the US in 2012.
The long-awaited move has come nearly three years after the FDA put bolder warnings on the long-acting opioid drugs, such as OxyContin, which released their doses at a slow pace over 12 hours or more. With the labeling switch, now both drug formulations will have to carry similar details regarding the risks of abuse, addiction, overdose and death.
In a statement, FDA Commissioner Dr. Robert Califf said that the most recent actions are among the biggest undertakings for telling prescribers about the risks of opioid products.
Since long, critics, such as the group Physicians for Responsible Opioid Prescribing, of the FDA’s approach to regulating opioids have petitioned the agency to put on warnings on immediate-release opioids.
Opioids include very strong and highly addictive drugs, including both prescription drugs such as codeine and hydrocodone, and illegal narcotics, such as heroin. Last year, prescription opioids brought more than $9 billion in sales for companies like Teva Pharmaceuticals, Johnson & Johnson’s Janssen Pharmaceutical, among many others.
As per the Centers for Disease Control and Prevention (CDC), in 2014, deaths associated with misuse and abuse of prescription opioids went up to 19,000, which was the highest figure on record.