Federal health regulators will bolster warning labels on the most widely used prescription painkillers, part of a multi-pronged government campaign to reverse 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 and non-prescription drug ingredients. 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 agency 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 in 2014, the highest figure on record, according to the Centers for Disease Control and Prevention. Heroin and opioid painkillers combined caused 28,650 fatal overdoses. 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 opioids after considering 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.
The Associated Press contributed to this article.
For the life of me I don’t know why the government wants honest citizens to suffer in pain. Secondly, while the pills kill pain, they leave you in a fog, not pleasant. Now I was given Valium for a procedure once and it was great.
Raise the price of Rx opioids so high that the addicts will either go to rehab or switch to heroin so that health professionals can be left to do their real jobs, not as law-enforcers.
Harry, the addicts will still get their fix, but a higher price would make it too expensive for those who really need the medication.
If the patient’s doctor is smart, the doctor will have tried all the OTC, and the therapies before they ever try the patient on the opioids. While on opioids, the patient will submit to random drug testing. The dosage level will be the lowest effective level and the most effective dosing whether using extended or immediate release is used. At least that is the procedure a pain management doctor uses.
If an opioid is used following a procedure the doctor is very specific about the number of doses to be used, for 3-4 days. maybe 4 doses per day. There are NO REFILLS without going back to the doctor.
I was on opioids for a period of time, but I was weaned off of them over a year ago. Any pain I have now is controlled by Advil and the appropriate therapy.
I am on prescription painkillers. Physical therapy will not help. My other option is a serious major back surgery which I have been cautioned against. I am not addicted nor do I abuse.
Yet.
Right On!!!
Those who abuse are usually not in pain. It’s rare for someone who needs the pain relief to become a “drug addict”. It is considered medication.
Amazingly, one of my sisters was on Vicodin 3x a day for 15 years, for 2 tremendously painful issues. After she finally had surgery, she went off them with no problems.
As usual, the “big boys” can’t be bothered with making distinctions,. Too much trouble. and, God forbid, they should provide “HELP” – rather throw them all in jail. thank you
There’s people die of smoking , alcohol , so why is the FDA getting on opoids , I lost my leg and toe’s on my other foot caused by Smoking so yes i’m in chronic pain so I take Vicodin 3 times a day. maybe if they high tax on Opioids like they do cigarettes and Alcohol that would fix this , O sorry allot of people love to smoke and drink even doctors and nurses !
I was prescribed Percoset after my surgery. I only took them when I needed. I stopped taking them. I didn’t want to be a zombie.
The drugs mentioned are good, useful drugs as long as they are used right. I am a Pharmacist and would hate to see legitimate patients not able to get pain killers, but I see so many cases of people either taking these pills too regular or they could be selling them to make extra money. An awful situation.
If you Need them especially with Degenerative Spine Disease Believe me you Don’t sell Them.
I have been on Vicodin for a couple of years for back and I only take it when I have a lot of back and neck pain and quit taking it because it caused me to itch so they told me to quit taking it and I now take tramadol when needed. I was not addicted at any time and could only take it when needed for severe pain. Ann
Right On!!!