The agency said 90 percent of opioid prescriptions in the US are for immediate-release painkillers, which contain less opioid per dosage compared with extended-release painkillers but need to be administered more frequently.
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In today’s guidance, the agency is encouraging industry efforts to develop pain medicines that are more hard to abuse.
At the same time, the CDC announced the proposed new guidelines for the prescribing of opioid painkillers, but the agency’s move was met with stiff opposition from drug companies, industry-funded groups, and some public health officials.
Thursday’s proposal comes just days after the FDA said it would add a new boxed warning – the most serious type – to some 175 immediate-release painkillers, including both branded and generics.
Deaths from opioid overdoses – both prescription narcotics and illicit street drugs, such as heroin – reached a record of 28,647 in 2014, according to the Centers for Disease Control and Prevention.
Critics of the FDA, including Physicians for Responsible Opioid Prescribing, called on the agency to add such warnings years ago.
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. The FDA wants all immediate release drugs to have a medication guide, but, again, it is up to the pharmacies.
“The higher dose strength of the extended release was more attractive for abusers”, FDA Commissioner Dr. Robert Califf said.
The FDA noted that encouraging access to generic ADF opioids is “an important step toward balancing the need to reduce opioid abuse with helping to ensure access to appropriate treatment for patients in pain”.
Government officials have already tried a variety of approaches to tackling painkiller abuse in recent years.
When a patient gets his or her prescription filled, the bottle should have a notification indicating there is a black-box warning for the drug.
The Obama administration has asked Congress to provide $1.1 billion to combat opioid addiction.
But Sen Edward Markey, D-Mass., who delayed Califf’s confirmation while he demanded that the FDA overhaul its approval process for opioid medications, issued a statement saying that “the labels given by the FDA have done little to prevent opioid addiction”.
“I think we’re very heartened by the new director of the FDA and his enhanced focus on opioid issues”, said Michael Botticelli, National Drug Control Policy Director.
The FDA will also update safety labels and risk information across all prescription opioid products in an effort to “reverse” the growing epidemic of opioid abuse.
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But Califf said to consider the needs of patients – for example, a veteran who has another 50 years to live, but has chronic pain.
