A trio of Democratic senators is encouraging the Food and Drug administration to pull ultra high-dose opioids from the market to help fight the opioid addiction crisis.
“Given the strength of a single dose of one of these opioids, it is shocking that such products remain on the market in the midst of our nation’s opioid epidemic,” Sens. Dick Durbin of Illinois, Joe Manchin of West Virginia, and Ed Markey of Massachusetts wrote in a letter to the FDA.
They also asked FDA to consider a request to take these products off the market that was presented in a citizens’ petition. “We urge you to heed this important, potentially life-saving request,” they wrote.
The letter focused on opioids that, when taken as directed by the label, exceed the Centers for Disease Control and Prevention’s daily threshold for opioid intake of 90 morphine milligram equivalents.
“For example, the OxyContin 80mg tablet can cause fatal respiratory depression when taken by a person without a high opioid tolerance — it is as powerful as 24 tablets of Vicodin,” according to the letter.
A major concern for the senators includes whether the high-dose opioids are accidentally ingested, borrowed or used recreationally. Federal data shows that more than 42,000 people died from an opioid overdose in 2016.
“Studies have shown that 12 million Americans misuse prescription opioids annually, and more than half of all misuse originates with a prescription opioid from a friend or relative,” the senators said. “It is our understanding that the FDA may have evidence and adverse events data to understand the scope of misuse from ultra-high dose opioids.”
They added that people who are in severe pain such as palliative or cancer-related pain could still get adequate treatment due to multiple pills, patches or formulations. The senators said they believe these people could still get good treatment if the high-dose opioids are removed from the market.
The letter comes as Congress is considering several opioid bills this year to combat the opioid epidemic, including bills aimed at stemming illicit shipments overseas of the powerful painkiller fentanyl.
