New FDA labeling for opioids
My personal experience with opioids began in 2002. I was in a bike accident that landed me in the hospital with a broken clavicle, four fractured ribs, a punctured lung and a concussion. During my 3-day stay in the hospital, I was connected to an IV morphine line. I don’t remember much of that stay, other than I couldn’t keep any food down. I was sent home with a prescription for Percoset, which was about as bad. I finally settled on hydrocodone, which didn’t leave me nauseous but blunted the pain. I was on hydrocodone for a month. The only complications were constipation and loss of short-term memory. I had no problem stopping. I’ve always been grateful to my docs for the prescriptions.
I see where the FDA is requiring new labeling for opioids:
“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.”
I never read the warning labels back in the day, but I was well-aware of the risks of overdose and addiction. My father-in-law was prescribed hydrocodone for pain after surgery and refused to take it for fear of addiction.
Opioid abuse is certainly a problem, both in the US and in other countries. If stronger labeling helps, great. Color me skeptical. One of the problems with opioids is tolerance, meaning that users have to up the dosage to achieve the same effects (I didn’t have this problem, either). Non-opioid analgesia for chronic pain (for example, the pain of cancer chemotherapy) is a focus of much NIH-funded research, research that is now threatened by Trump Administration budget cuts. That research will have more impact than FDA labeling.
New FDA labeling for opioids
I see where the FDA is requiring new labeling for opioids:
“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.”
I never read the warning labels back in the day, but I was well-aware of the risks of overdose and addiction. My father-in-law was prescribed hydrocodone for pain after surgery and refused to take it for fear of addiction.
Opioid abuse is certainly a problem, both in the US and in other countries. If stronger labeling helps, great. Color me skeptical. One of the problems with opioids is tolerance, meaning that users have to up the dosage to achieve the same effects (I didn’t have this problem, either). Non-opioid analgesia for chronic pain (for example, the pain of cancer chemotherapy) is a focus of much NIH-funded research, research that is now threatened by Trump Administration budget cuts. That research will have more impact than FDA labeling.
New FDA labeling for opioids
Opioids have been my only analgesic for close to a quarter century. NSAIDS already burnt out my kidneys (which I believe, but cannot prove) and Tylenol just isn’t enough. Fortunately my pain is chronic, but not constant. Only once did I become physically dependent on my drugs (hydrocodone/acetaminophen), and it took me as long to realize that as it did to cold-turkey end my dependence. That was about 15 years ago, and only recently have I needed to take so many drugs so frequently that I need to worry about it again.
One of my very early prescriptions came in the manufacturer’s bottle and had their physicians information attached. At that time they were making single pills that contained 8 times the dosage of opiate which my pills contained (5/500). The NTE for my dosage was 20 pills a day. They happily gave me a 100 day supply in a bottle about 9 inches tall, with 4 refills – good for a calendar year. The war on opiates changed that dramatically.
Most people who are given opioids for pain are like you. They have a specific acute problem and they take what they need until they don’t need it. Hospitals monitor dosages to minimize any addiction possibility, and most people don’t take medicine they don’t need. Something like 6-7% of people given opiates for pain actually become addicted, which is different from developing a tolerance or physical dependence.
I will read the warning labels, and may or may not find information I need to discuss with my doctor. The information is useful and possibly necessary for someone with a new prescription but long term users like myself have already learned about the rest (except fatal overdoses) through personal experience. At least now there is a possibly new category of analgesic drug – Duke is getting ready for clinical trials. Whether it will be more kidney-safe than opiates is TBD.
We need to see if we can determine who will and will not become easily addicted. Not likely with the current admin and their attitude to scientific research.
Jane:
You are mistaken right?
“At that time they were making single pills that contained 8 times the dosage of opiate which my pills contained (5/500). The NTE for my dosage was 20 pills a day. They happily gave me a 100-day supply in a bottle about 9 inches tall, with 4 refills – good for a calendar year. The war on opiates changed that dramatically. “
If they gave me anything, I was unaware of it. I dislike the doped-up feeling of of taking the medical-supplied drugs.
I do agree that this administration could cares less for what it does and allows.