FDA Slaps Stronger Warnings on Opioids

New labeling will require drugs to warn against long-term use of the addictive analgesics

https://www.medpagetoday.com/painmanagement/painmanagement/116776

Opioid medications will be required to have their labeling updated to highlight the safety risks of long-term use, the FDA said.

The agency is requiring opioid manufacturers to add to the prescribing information that higher doses are associated with increased risk of serious harm, and that the risks of serious harms persist over the course of therapy, among other changes.

Based on results of two postmarketing observational studies — and the FDA advisory committee meeting discussing them this May— new quantitative estimates of the risks of addiction, abuse, misuse, and fatal and non-fatal overdose in patients taking opioid analgesics long-term are also expected in labeling updates.

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said FDA commissioner Marty Makary, MD, MPH, in the press release. “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and postmarket monitoring so that nothing like this ever happens again.”

Of course, about FIVE TIMES  the number of people died from the use/abuse of tobacco/nicotine. Also during the same time frame  a similar number of people died of the use/abuse of alcohol.

Are those deaths just socially acceptable because they provide a healthy tax revenue stream to various bureaucracies?

The studies were postmarketing requirements the FDA requested in 2013 of all companies with new opioid analgesics for chronic noncancer pain. Together, the two studies showed that the 12-month incidence of long-acting opioid misuse was about 15-22%, the incidence of abuse roughly 6-9%, and about 1-6% had moderate-to-severe opioid use disorder.

SO… is it going to be acceptable to deny >78% of the chronic pain pts their medically necessary opioid medications to properly manage their chronic pain and optimize their QOL ?

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Are pharmas, wholesalers , pharmacies, prescribers, large healthcare corporations & insurance/PBM going to have some legal liabilities if they are the direct/indirect reasons that a pt is thrown into cold turkey withdrawal and having to endure a torturous level of pain because the pt is not able to get their medically necessary pain management medication ?

The FDA is now requiring that opioid labels emphasize the importance of avoiding rapid dose reduction or abrupt discontinuation in patients who may be physically dependent on opioid pain medicines, as it can cause serious harm.

Opioid makers are being given 30 days to submit their labeling updates to the FDA for review.

“I know firsthand how devastating addiction is — not just for individuals, but for entire families and communities,” said HHS Secretary Robert F. Kennedy, Jr. “Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”

Filed under: General Problems