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Thursday, March 24, 2016

‘Black box’ addiction warnings for 175 prescription painkillers to stem 'epidemic of abuse and overdose'




‘Black box’ addiction warnings for 175 prescription painkillers to stem 'epidemic of abuse and overdose'




US health regulators will add their strongest warning labels to prescription painkillers, such as Vicodin and Percocet, to stem the epidemic of opioid abuse.
The Food and Drug Administration revealed plans to add a 'black box' warning to all immediate-release prescription opioid painkillers - which includes nearly 175 branded and generic drugs.
Those medications are among the most commonly prescribed drugs in the US - accounting for 90 per cent of all opioid painkillers.
The FDA added similar warnings to long-acting drugs - such as OxyContin, which release their dosage slowly, over 12 hours or more - nearly three years ago. 
But now, both immediate and extended-release formulations will contain warnings that detail the risks of addiction, abuse, overdose and death.

The warning label changes come as US officials struggle to curb a surge in overdoses, which stem from the overprescribing of medications and readily available, inexpensive heroin.
Dr Robert Califf, commissioner of the FDA, told the Associated Press: 'We're at a time when the unfathomable tragedies resulting from addiction, overdose and death have become one of the most urgent and devastating public health crises facing our country.
'I can't stress enough how critical it is for prescribers to have the most current information.'  

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