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Committee Democrats Seek Stronger Labeling of Opioids

Jun 5, 2015
Press Release

Currently, only extended-release and long-acting opioids have prominently displayed warnings, known as “black box warnings,” that indicate the significant potential for abuse, overdose, addiction, and neonatal abstinence syndrome.  The Democratic Committee leaders asked that these same warnings be placed on immediate release opioids, which have the same risks and accounted for over 90% of the opioids prescribed in the United States in 2009, according to FDA. 

“Between 2000 and 2010, there was a fourfold increase in the use of prescribed opioids for the treatment of pain.  This increase in opioid prescriptions has been mirrored by a fourfold increase in opioid-related overdose deaths:  between 1999 and 2010, the death rate from prescription opioids more than quadrupled,” the lawmakers highlighted in the letter.

They continued, “Given the national public health crisis of prescription drug overdoses, an issue that has been a subject of extensive examination by the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, we believe this common sense approach would equip patients and prescribers with information necessary to make informed decisions regarding the risks of opioid analgesics.”

The lawmakers also highlighted the skyrocketing incidence of neonatal‎ abstinence syndrome.  According to a recent study in the New England Journal of Medicine, from 2004 through 2013, the incidence of NAS quadrupled.  They noted, “It is critical that pregnant women and their physicians have access to clear, concise information about the risks of NAS when considering whether to prescribe opioid therapies during pregnancy, and we are concerned that the current labeling for IR opioids does not meet this threshold.”

The leaders requested a response to their letter as well as an approximate timeline for any planned labeling change by June 29, 2015.

The full text of the letter can be found here.