By Ed Coghlan
The U.S. Food and Drug Administration continues to increase the pressure on the prescription of opioids. It said Tuesday that all fast-acting opioid pain medicines will be required to carry its strongest warning about risks, including the risks for abuse, addiction, overdose and death.
“This epidemic touches all corners of our nation and is devastating individual lives, communities and our nation,” said FDA Commissioner Robert Califf during a briefing for reporters. He called the epidemic the “most urgent and devastating public health crisis facing our nation.”
More than 200 fast-acting versions of opioids, such as oxycodone, hydrocodone and morphine, have been targeted. Ninety percent of all opioid prescriptions are for these fast-acting, or immediate-release, formulations.
The so-called “Black-box” warnings are the toughest the agency can require. Prescribing physicians tend to pay attention to these warnings.
The FDA wants to warn doctors and patients about the dangers of the drugs while ensuring they remain available for patients who need them to alleviate pain. However, Califf stressed the drugs should be reserved for severe pain for which no alternatives are available.
When taken with antidepressants and migraine medications, opioids can also cause a potentially life-threatening central nervous system condition known as serotonin syndrome, which occurs when the body is overloaded with the brain chemical serotonin.
Earlier this month, The Centers for Disease Control and Prevention (CDC) announced new voluntary guidelines for medical professionals about when and how much opioid medication is appropriate to prescribe for chronic pain. Here’s a National Pain Report story on the CDC guideline.
While acknowledging that opioids are often prescribed to combat chronic pain, the agency said the risks far outweigh the benefits for most patients with long-term pain, except for those receiving cancer treatment or end-of-life care.
“More than 40 Americans die each day from prescription opioid overdoses, we must act now,” said CDC Director Tom Frieden, M.D., M.P.H. “Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug-overdose epidemic. The guideline will give physicians and patients the information they need to make more informed decisions about treatment.”
The FDA announcement today tells chronic pain patients that the government’s emphasis is on addiction, not on chronic pain treatment.
It reads: “Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.”
Here’s the FDA press release.