Opioid Manufacturer Gets FDA Warning Letter Over Lack Of Risk Information
Federal regulators indicate that Collegium Pharmaceutical, Inc., the makers of the opioid drug Xtampza ER, failed to provide adequate warnings about risks associated with the medication, in what some see as a sign of the agency cracking down on how the powerful pain pills are marketed.
FDA warnings to pharmaceutical companies have been few and far between so far in the Trump administration, but the agency took the time to single out Collegium in a letter (PDF) last month.
The FDA’s Office of Prescription Drug Promotion (ODPD) indicates that the company failed to warn of serious risks linked to the use of Xtampza ER at a major conference last summer.
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Learn More“The exhibit booth was displayed at the American Society Health-System Pharmacists (ASHP), and viewed by an OPDP representative. The exhibit booth makes false or misleading representations because it fails to adequately communicate information about the serious risks associated with Xtampza ER use,” the letter states. “These violations are particularly concerning given the serious public health impacts of opioid addiction, abuse, and misuse that can lead to overdose and death.”
While a small infraction, compared to a warning regarding a widely used label or direct-to-consumer advertising, the letter came just days after FDA Commissioner Scott Gottlieb announced new FDA plans for combating the opioid abuse crisis. Some say the letter is a product of the agency’s new, tougher policy on opioids in action.
The letter notes that the prescribing information for Xtampza ER contains boxed warnings for addiction, abuse, misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome and interactions with other drugs, in addition to other contraindications and less serious warnings.
The agency also indicates that Collegium has a history of these types of problems, and that ODPD warned Collegium in September 2016 on presentations that, similar to the booth, failed to provide adequate risk information. There were warnings at the booth, but they were on a side panel several feet away in small text and likely missed by most observers, the letter notes.
In addition, the booth represented the drug’s abuse-deterrent properties in a misleading way, putting the benefits in prominent text at eye level, and the fact that there were still ways the drug could be abused near to the floor and behind a chair.
The FDA has called for Collegium to turn over all of its promotional materials and explain how it plans to avoid such missteps in the future.
Opioid Crisis
In the United States, evidence now suggests that drug overdoses kill more people than gun homicides and car crashes combined. In fact, between 1999 and 2015, more than 560,000 people died from drug overdoses. Even as abuse has seemingly decreased, opioid overdose deaths have increased.
In 2015, two-thirds of drug overdoses were linked to opioids, including Percocet, OxyContin, heroin, and fentanyl, which on its own is largely driving the number of opioid deaths.
Americans use more opioids than any other country in the world, with the number of prescriptions in the U.S. last year providing enough pills to medicate every American 24 hours a day for three weeks consecutively. Opioid overdoses kill more than 90 Americans every day, experts say, and the economic burden of opioid misuse costs the country $78.5 billion per year.
11 Comments
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MelissaNovember 28, 2022 at 5:03 pm
I gained 20 lbs in 2 months. No appetite. No energy. Breathing issues. Never again.
SheriOctober 27, 2022 at 1:42 pm
I too gained weight. I had been at the same weight all my life and gained 20 lbs. However I am not eating and have absolutely no appetite. My sodium went way down and I ended up in the ER. I also have hot flashes and sweat at night. I do not want to be on this medication any longer. It is killing me. I would rather be in pain and lay in my bed all day.
TommyAugust 7, 2021 at 4:38 pm
i was on oxycotion they put me on extampza now i am having problems with a fatty liver i did not have that problem on the oxys
TommyAugust 7, 2021 at 4:37 pm
i was on oxycotion they put me on extampza now i am having problems with a fatty liver i did not have that problem on the oxys
MelodyApril 24, 2021 at 7:40 am
I have been a chronic pain patient since 2008. I have been on everything under the sun. I can't take Morphine, Buprenorphine, Methadone, and I have issues with transdermal Fentanyl (it's the adhesive, not the drug that is the problem. I had a Roux-en-y Gastric Bypass in November of 2010. Since then, I can no longer take oral NSAIDs. Six years into my Gastric Bypass, I almost died from malnutrition[Show More]I have been a chronic pain patient since 2008. I have been on everything under the sun. I can't take Morphine, Buprenorphine, Methadone, and I have issues with transdermal Fentanyl (it's the adhesive, not the drug that is the problem. I had a Roux-en-y Gastric Bypass in November of 2010. Since then, I can no longer take oral NSAIDs. Six years into my Gastric Bypass, I almost died from malnutrition due to a stricture in my stomach pouch. Surgeon did a revision on my pouch and found my liver eating into my stomach. So, no more acetaminophen for life too. I was comfortably on Dilaudid 4mg BID and Oxycontin 10mg. On comes the opioid panic and the pain management doctors started goofing around with my meds. Now, on Xtampza 18mg and Oxycodone 15mg. I seriously believe that I am not absorbing the Xtampza and my IR Oxycodone just isn't able to manage my pain by itself. My doctor and I are going to have a "come to Jesus" conversation next week. My pain levels are intolerable. There's no clear labeling on Xtampza's ability to work with Gastric Bypass patients, but I believe that it's not working. I've been on it over 6 months and it's apparent that I have given it an honest effort. If there's a class action suit against this crappy med, sign me up.
SherryJuly 30, 2020 at 9:59 pm
Xtampza is the next killer medicine & it won't be from overdoses, it will be by the hidden side effects & permanent damage. The pharmaceutical company is charging just as much money for it as they did for oxycontin & hiding the severity of complications. They rushed the xtampza out to curb political pressure without extended clinical trials. The FDA is letting this happen & they are just as respon[Show More]Xtampza is the next killer medicine & it won't be from overdoses, it will be by the hidden side effects & permanent damage. The pharmaceutical company is charging just as much money for it as they did for oxycontin & hiding the severity of complications. They rushed the xtampza out to curb political pressure without extended clinical trials. The FDA is letting this happen & they are just as responsible. If the politicians, pharmaceutical companies & FDA cared about the liability they wouldn't continue to allow potentially killer medications to be approved & pushed on patients by their doctors. The only thing they care about is filling their pockets!!! I have medicine allergies & I can't take morphine or fentanyl, I had been told by the Dr that the xtampza was the same as the oxycontin without the addictive qualities & more affordable so mistakingly trusting my dr I agreed to try it. The 1st couple months the side effects were minimal but the longer I've taken the worse they have become to the point of scaring me. You shouldnt have to choose suffering without medicine or being forced to take a harmful medicine to ease your chronic pain. I've asked for 2 months to be put back on my old medicine & the dr won't listen because he hasn't heard of any complaints of side effects which is a total lie!!! I'm refusing to take it anymore unless my dr signs a contract stating if I die from complications of xtampza that he is responsible. Do you think he'll sign it?!? No he won't because the pharmaceutical companies, FDA & doctors know that the effects of xtampza are damaging. If patients have years of medical records showing they require pain medication they shouldnt be made to suffer more by a greedy politics, pharmaceutical corps, the FDA & Drs getting perks to push bad medicine. Let me know when there is a lawsuit for xtampza, it's dangerous!!!
Jen-ER nurseJuly 1, 2020 at 10:58 am
As an ER nurse in Ohio, I have seen some very inconsistent results with Xtampza ER. Some accidental overdoses due to “dose dumping” in some patients and ineffectiveness in others. The release system is the problem. Despite many reports of this problem, the drug remains on the market and no advisories of these risks have been released. The war on drugs has turned into a war on some of our most vuln[Show More]As an ER nurse in Ohio, I have seen some very inconsistent results with Xtampza ER. Some accidental overdoses due to “dose dumping” in some patients and ineffectiveness in others. The release system is the problem. Despite many reports of this problem, the drug remains on the market and no advisories of these risks have been released. The war on drugs has turned into a war on some of our most vulnerable members of the population. While patients should have a legitimate and proven medical condition in order to be prescribed opiates, the abuse proof formulations are dangerous in some cases. The law and the doctors need to focus on prevention of diversion and the drug companies need to listen to the patients and their comments in addition to reported adverse incidents in ER’s and hospitals. The rush to make abuse deterrent opioids is not only potentially harmful without the proper warnings, the deaths are going up. Nobody talks about the illegal drugs being the big factor (heroin and cocaine laced with carfentanyl and addicts shooting straight fentanyl. This is being imported from South America and China. Adding services and help for addicts is a big factor in lowering deaths, but it MUST be acknowledged that the majority of deaths we see at this point are from illegal “Laced” narcotics.. It’s seriously less common with prescription pain drugs at this point. As a result of laws that have been enacted, I see too many ER patients without proper pain control for legitimate illness and/or injury. Most don’t get any pain relief. We simply aren’t permitted to give appropriate help for many patients when needed. We medicate most people for surgery or cancer and rarely for shingles, gallbladder problems, and we have sent kidney stone patients home many times without appropriate medication depending on the doctor on duty. ACCOUNTABILITY works both ways. While many of us see that there is a problem with quality of care in pain management, the laws have their hands tied and there is little they can do.
Mary AnnApril 12, 2020 at 5:38 am
When the medication Opana (which was very helpful for me!) was pulled from the market, I was put on Xtamza. This was in October of that year. In early November, I noticed I could barely fit into my pants! Well, I stopped at the thrift store and bought a couple of pair of larger jeans, and decided I needed to watch my snack intake. At the beginning of December, at my next monthly appointment, I a[Show More]When the medication Opana (which was very helpful for me!) was pulled from the market, I was put on Xtamza. This was in October of that year. In early November, I noticed I could barely fit into my pants! Well, I stopped at the thrift store and bought a couple of pair of larger jeans, and decided I needed to watch my snack intake. At the beginning of December, at my next monthly appointment, I again discovered I needed to stop at the thrift store to get still larger pants! I decided that the sweets and pies and such from Thanksgiving made me pack on the pounds, so I endeavored to cut out the extra calories from holiday treats. But then, by the end of the year, and the first of January, I needed still LARGER pants! At my January appointment, I stated I had gained over 30 pounds. I stated I was concerned that perhaps the new medicine was causing it. My doctor seemed a bit skeptical, and no changes were made. And yet, by the end of January, I needed still LARGER pants! I basically INSISTED that I needed different medication by the time I had my February appointment. I pointed out that, after being steady in my weight for over a decade, and only gaining 5 pounds after I stopped working due to my accident, and stayed at that 5 extra pounds, for 4 years. And yet, the moment I was put on Xtampza, I started ballooning! I had gained FIFTY POUNDS in 5 months!! I insisted I HAD to go on something else! Well, my doctor finally listened to me, and my medicine was changed, FINALLY, in February. I stopped gaining weight nearly instantly! Yet, I have this 55 pounds on me now that I NEVER had before, and with it, on top of my other medical issues, I can't lose it! I am STUCK with this extra weight that this evil medication forced onto me, with no way to lose it, because I can't exercise like normal people. I can't even walk for more than a block without severe pain, AND the pain levels are worse than they ever were before, too. If there is EVER a lawsuit about Xtampza and incredibly fast, very dangerous weight gain, I want in on the ground floor! It has ruined my life worse than the disabling injury itself did!
JonJanuary 9, 2020 at 7:39 pm
I am a 67 year old male, Jon N. Wohrer I have had 12 back surgeries, my back has screws and titanium rods from the C-4 vertebrae all the way down to my sacrum, minus 2-3 Vertebrae I have been on so many different pain meds. About 2 years ago my pain doctor introduced a new pain med called Xtampza ER which, supposedly released its dose gradually over a 12 hour period. My doctor said I would only[Show More]I am a 67 year old male, Jon N. Wohrer I have had 12 back surgeries, my back has screws and titanium rods from the C-4 vertebrae all the way down to my sacrum, minus 2-3 Vertebrae I have been on so many different pain meds. About 2 years ago my pain doctor introduced a new pain med called Xtampza ER which, supposedly released its dose gradually over a 12 hour period. My doctor said I would only need to take one XTAMPZA capsule in a 12 hour period instead of 1 oxycodone every 4 hours. It seemed to work for 2-3 days. Then one day I took my morning capsule, then I fell into a deep sleep,. in which my wife tried to wake me up.,and after several attempts to wake me up were unsuccessful. she called 911. The next time I woke up, I was in the local hospital ER .a nurse asked me if I knew where I was, I replied, "I don't know." The nurse told me I was in the ER, and I overdosed and was revived after I was given Narcan. I told them there was no way I could have overdosed. I took only one Xtampza ER. I am always very careful when I pack my meds in my weekly pill container. My wife even counted my remaining pills, and the correct amount were In the RX bottle. I insisted I did not overdose myself, no way !!. My doctor told me that only one Xtampza could not overdose me.Well anyway, I believed my doctor. He told me he was going to prescribe me more Xtampza,but in a higher dose. Then it happened again, I was in the ER, waking up, after receiving Narcan. The last thing I remembered I was drinking my morning coffee. I was so humiliated that almost every one thought I overdosed, again. My wife knew I only took one Xtampza. Apparently I was a victim of "dose dumping". Instead of the medicine gradually dissolving into my bloodstream it dumped the whole dose all at once. Can you please help?
CecilAugust 15, 2019 at 5:39 pm
I am 62 with lots of pins , screws ,and rods in my neck and lower back. I was taking 60 mg oxycotin and 400 mg tramadol a day. Now I am taking 27 mg Xtampza twice daily and 30 mg Tyl.3. I had Roux- an- y gastric bypass surgery back in 20001. I have had trouble with Extended Release Meds. every sense . xtampza not only has the absorption problem it also causes several stomach problems such as cramp[Show More]I am 62 with lots of pins , screws ,and rods in my neck and lower back. I was taking 60 mg oxycotin and 400 mg tramadol a day. Now I am taking 27 mg Xtampza twice daily and 30 mg Tyl.3. I had Roux- an- y gastric bypass surgery back in 20001. I have had trouble with Extended Release Meds. every sense . xtampza not only has the absorption problem it also causes several stomach problems such as cramps and nausea which I had before starting Tyl. 3 . Fear due to opioid addiction in America has caused Doctors to latch on to xtampz a and other Extended Release meds. The F D A suggests not going over 90 mg this leaves me in pain pulse stomach problems. Please thank the next Drug Addict you see and Mr President for adding pain relief to the long list of things taken by them.
RobertMarch 12, 2019 at 12:39 am
As of January 1st, my insurance would no longer approve the Oxycontin that I had been taking for 7 years. They told me that they would only cover Xtampsa 36ER. I really had no choice and after having to pay for my meds in January I had to let them make my doctor use it on me. I had a fatty liver, diabetes, kidney stones a nonworking gal bladder surgery on my knees three on a crushed spine and on[Show More]As of January 1st, my insurance would no longer approve the Oxycontin that I had been taking for 7 years. They told me that they would only cover Xtampsa 36ER. I really had no choice and after having to pay for my meds in January I had to let them make my doctor use it on me. I had a fatty liver, diabetes, kidney stones a nonworking gal bladder surgery on my knees three on a crushed spine and one on my neck along with Roux-en-Y gastric bypass surgery. I am the last person you would use this horrible medicine on. For one it did not help any of my pain, I had 90% of the side effects and some like stomach cramps and nausea horribly bad. Take every warning seriously for I believe if they continued to force me on to this it would kill me within three months. I am still having bad stomach problems and bleeding from my belly button. I do have a doctors visit coming up for these developing problems. The FDA really needs to step in and get rid of this drug.