FDA bolsters warnings on most widely-used painkillers

March 22, 2016

WASHINGTON (AP) — Federal health regulators will bolster warning labels on the most widely used prescription painkillers, part a multi-pronged government campaign to tame an epidemic of abuse and death tied to drugs like Vicodin and Percocet.

The Food and Drug Administration announced Tuesday plans to add a new boxed warning — the most serious type — to all immediate-release opioid painkillers, including combination pills containing oxycodone. Those drugs, sold as Vicodin and many generic brands, are consistently among the most prescribed drugs in the U.S., accounting for more than 135 million prescriptions in 2012.

The long-awaited change comes roughly three years after the FDA added bolder warnings to long-acting opioid drugs like OxyContin, which slowly release their doses over 12 hours or more. The labeling switch means both drug formulations will now carry similar information about the risks of addiction, abuse, overdose and death.

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products,” said FDA Commissioner Dr. Robert Califf, in a statement.

Critics of the FDA’s approach to regulating opioids, including the group Physicians for Responsible Opioid Prescribing, have for years petitioned the FDA to bolster warnings on immediate-release opioids.

Opioids are a class of powerful and highly-addictive drugs that include both prescription drugs like codeine and hydrocodone, as well as illegal narcotics, like heroin. Prescription opioids accounted for over $9 billion in sales last year for companies like Teva Pharmaceuticals, Johnson & Johnson’s Janssen Pharmaceutical, Purdue Pharma and others.

Deaths linked to misuse and abuse of prescription opioids climbed to 19,000 last year, the highest figure on record, according to the Centers for Disease Control and Prevention. Heroin and opioid painkillers combined caused 28,650 fatal overdoses in 2014. Many prescription opioid abusers eventually switch to heroin because it sells for up to five times less than pills or tablets.

Government officials have already tried a variety of approaches to tackling painkiller abuse in recent years. The FDA previously restricted drugs like Vicodin to limit refills and who can prescribe them. States like Florida and New York have cracked down on “pill mills” using databases to monitor what doctors are prescribing. Earlier this month, Massachusetts signed into law a seven-day limit on first-time prescriptions for opioids — the first of its kind in the nation.

The FDA announcement comes less than a week after the CDC released the first-ever national prescribing guidelines for using opioids. The agency said primary care doctors should only turn to opioid after trying physical therapy, over-the-counter medications, counseling and other methods for treating chronic pain. When prescribing opioids for short-term pain, the agency said doctors should prescribe a 3-day supply, whenever possible.

10 Comments

  1. homneopathy news

    December 9, 2016 at 8:28 PM

    thank you for sharing useful information..almost everyone’s used this type of pain killer tablet.the tablet do not used for daily because we are addicted for that and over dose and death.get a a information about me the application Pill mills.it used for monitor which doctor doctors are prescribe this tablet.

  2. Pengobatan Sipilis Tanpa Ke Dokter

    April 27, 2017 at 7:10 AM

    Excellent information. This really made me add knowledge. Thank you very much. Hope Always update

  3. Apa Obat Di Apotik Untuk Penyakit Sipilis

    April 28, 2017 at 7:00 PM

    Thank you for the information. Hopefully update always let me add my insight. The site I am most waiting for updates

  4. Apa Penyebab Kencing Mengeluarkan Nanah

    May 22, 2017 at 7:14 PM

    True, this is what I think too. Although somewhat different in opinion about the discussion, but mostly I agree with this site. Hope it always updates so I always increase my insight

  5. Keluar air nanah dari kemaluan

    May 22, 2017 at 7:53 PM

    I always like what in this site post, always provide the information I need. Hope it always updates so I can add my insight from this site. Thank you

  6. Obat Kencing Nanah Dan Gonore

    May 28, 2017 at 11:07 PM

    Thank you for the information..

  7. Obat keluar nanah dari kelamin

    June 2, 2017 at 11:27 PM

    I always follow this development. Whatever is done there is always a support and no. But for me, on this site shows the best thing for public consumption. Thank you very much. Hope it always updates so I can add my insight through this site.

  8. Obat Hipertiroid Herbal

    August 4, 2017 at 6:25 AM

    Great information.

  9. Khasiat Teripang Sebagai Obat Kanker

    August 11, 2017 at 6:53 AM

    Great article

  10. Nice post.

moose knuckles pas cher moose knuckles pas cher moose knuckles pas cher moose knuckles pas cher moose knuckles pas cher moose knuckles outlet moose knuckles outlet moose knuckles outlet moose knuckles outlet moose knuckles outlet maillot de foot pas cher maillot de foot pas cher maillot de foot pas cher maillot de foot pas cher maillot de foot pas cher scarpe nike air max outlet scarpe nike air max outlet scarpe nike air max outlet scarpe nike air max outlet scarpe nike air max outlet scarpe nike air max outlet nike tn pas cher nike tn pas cher nike tn pas cher nike tn pas cher air max pas cher air max pas cher stone island outlet stone island outlet stone island outlet stone island outlet stone island outlet stone island outlet barbour pas cher barbour pas cher barbour pas cher barbour pas cher barbour pas cher nike tn squalo nike air max outlet mcm outlet online moose knuckles outlet happiness outlet happiness outlet shoes