Orally Dissolving Buprenorphine Tied to Severe Tooth Decay, FDA Warns

Orally Dissolving Buprenorphine Tied to Severe Tooth Decay, FDA Warns

https://www.medscape.com/viewarticle/966562

Orally dissolving medications containing buprenorphine are linked to severe dental problems, including total tooth loss, the US Food and Drug Administration (FDA) warns in a safety communication.

The oral side effects of these medications, which are used to treat opioid use disorder (OUD) and pain, include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.

Multiple cases have been reported even in patients with no history of dental problems.

The FDA is adding a warning about the risk of dental problems to the prescribing information and the patient medication guide for all buprenorphine-containing medicines dissolved in the mouth.

The FDA emphasizes, however, that buprenorphine remains “an important treatment option for OUD and pain, and the benefits of these medicines clearly outweigh the risks.”

More Than 300 Reported Cases

Buprenorphine was approved in 2002 as a sublingual tablet, and in 2015 as a film to be placed inside the cheek to treat pain. Both delivery methods have been associated with dental problems.

Since buprenorphine was approved, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine, including 131 classified as serious.

There may be other cases, the FDA says, as these represents only cases reported to the FDA or published in the medical literature.

The average age of the patients who developed dental problems while taking buprenorphine is 42 years, but those as young as 18 years old were also affected.

Most cases occurred in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain.

In 26 cases, patients had no prior history of dental problems. Some dental problems developed as soon as 2 weeks after treatment began; the median time to diagnosis was about 2 years after starting treatment.

Among all 305 cases reported, 113 involved two or more teeth.

The most common treatment for the dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases required root canals, dental surgery, and other procedures such as crowns and implants.

Recommendations

The FDA says healthcare providers should counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of transmucosal buprenorphine-containing medicines and emphasize the importance of visiting their dentist to closely monitor their teeth.

Patients should be counseled to continue taking buprenorphine medications as prescribed and not stop suddenly without first talking to their healthcare provider as this could lead to serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.

Patients are also being advised to take extra steps to help lessen the risk of serious dental problems.

Patients should also be educated on strategies to maintain or improve oral health while taking transmucosal buprenorphine medicines.

After the medicine is completely dissolved, the patient should take a large sip of water, swish it gently around the teeth and gums, swallow, and wait at least 1 hour before brushing their teeth, the FDA advises. This will allow time for the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.

The FDA also advises that patients tell their provider about any history of tooth problems, including cavities, and schedule a dentist visit soon after starting the medicine.

Dental problems related to transmucosal buprenorphine-containing medicines should be reported to the FDA’s MedWatch program.

4 Responses

  1. I had perfect teeth. Hydro started the dry mouth way back in 2012. It’s dry mouth that the bacteria love. MANY meds cause dry mouth. Only solution is a good dentist or periodontist (mine dumped me after he said he would fix it, NO options left) OR glycerin, the same stuff that is in a $9 tube of BIOTENE.

    • Prior to being started on opioids, I have taken a hormone for nearly 20 years now, which is notorious for bone density loss and causing teeth to crumble. I’ve now broken my wrist while pulling on my clothing after a shower and broken a tooth in half eating scrambled eggs. While there is no question that opioids can cause dry mouth, which can in turn prompt dental issues, my former comment is an example of why simply being on prescribed opioid pain medication isn’t always the culprit for oral health issues and it is certainly not a valid indicator of addiction, as so many seem willing to believe. It’s horrifying to me that dentists would be so willing to carry such a belief and even go so far as to deny a person dental care due to their own mischaracterized assessment of the events, without acknowledging a patient’s history.

      It’s frankly unbelievable that dentists would deny care to someone in need, no matter what their status is or is not. If the individual has not requested pain medication, it should be a non-issue. This is why I feel that it’s prudent to exercise extra caution when using medications that are associated with so much stigma already and with this one causing marked dental issues, it may pose more of a problem than people realize. Of note, there are other options out there if the issue is only dry mouth due to opioid use prompting or exacerbating oral health problems. There are premedicated sponges on a stick (forgive me for not remembering what they’re called right off) that can be used to clean the mouth for example, if dry mouth and needing to clean the teeth without being able to brush are the only elements that need to be addressed.

      My former comment was meant to be a type of cautionary tale as to what might be expected if dental issues get to a point where they go beyond opioid use. I was a 2x per day tooth brusher, used dental pipe cleaners, flossed and used mouthwash daily, prior to becoming seriously ill. I believed that my teeth were in great condition because I was unaware that a biofilm infection requires somewhat aggressive treatment and an even more vigilant effort than I was putting forth to begin with. So once I became ill and was not able to brush on a regular basis, on top of my teeth being softer due to treatment with hormones and then being unable to afford dental work, it was a recipe for disaster that was unfairly ascribed to being on opioid medication. In the form of opioid abuse even, which was a totally unwarranted claim and without merit.

      This is the reason that I would recommend giving this medication a lot of thought prior to going onto it, although it’s admittedly doubtful that there would be many, if any, alternatives offered. Stigma exists in every corner of life anymore, for chronic pain patients. It’s just disturbing that something which used to be seen for what it was -a necessary treatment to effectively reduce pain which may cause dry mouth and thereby dental issues- has been so politicized that it would see people being denied dental care over nothing more than a treatment that they require for physical issues outside of a dentist’s scope of practice.

      While I am aware that Buprenorphine is an addiction medication, I am also aware that chronic pain patients have been told that this is all that they can receive in some instances. In my mind, it shouldn’t matter why a patient is taking the medication if the dentist is not being asked for more or different opioid medications. At some point, dental work goes beyond optional and into territory where dental problems can become life threatening if left untreated so it’s inexcusable from my point of view, to deny care based on the possibility that a patient is an addict. But again, that has indeed been my experience. Whether or not a person’s oral health problems are related to dry mouth from opioid use, addiction or other extenuating factors, it shouldn’t result in a denial of dental care. It’s just inconceivable that the combination of being on certain medications and oral health issues could be used as an excuse to refuse to provide care. Just as much as I believe that it’s unacceptable to deny care concerning a patient on certain medications and having physical/mental issues. Yet, here we are, in an era where we have to be extremely cautious with what we accept for treatment or pay the consequences for failing to do so, sometimes over nothing more than the perception and personal beliefs of another individual.

  2. Once this happens to your teeth, it’s all over with from there. I am a chronic pain patient, no history of drug abuse or addiction. My teeth are in absolutely deplorable condition, but my experience has been that I have had dentists refuse to take me as a patient because they believe (based on sight alone) that I am a drug addict.

    I’ve tried to relay to them that I spent 2 years extremely ill, not able to eat and drink normally, nauseated and vomiting on a regular basis and not in any shape to take care of myself, let alone brush my teeth. I already had oral health issues, prior to even starting opioids or becoming ill, that were not clearly explained to me by the dental hygienist that I saw who acted like she didn’t want to touch me when I had all of my teeth and was seeking cleanings so I could keep my teeth in good shape. I then spent another 2 years being homeless and without income, preventing me from seeking dental help due to my situation. I do take one medication that is known to cause dental woes but it isn’t an opioid. It’s a hormone whose absence would cause medical devastation, if I didn’t take it. It’s known to cause teeth to crumble, like mine do. I’ve been on it for nearly 2 decades now. But because I was on opioids that HAD TO have been the problem, according to the dentists that I tried to see. When you honestly consider all of these things, they’re not really conducive to maintaining dental health or seeking dental work in an attempt to prevent the rapid decline.

    Now, I can’t get a dentist to take me as a patient, even though I have the ability to cover the dental work. I even had one dentist threaten to turn my doctor in for turning me into a ‘junkie’ (his ignorant assessment). So now I have to worry about losing medication just going have my dental needs addressed, IF I can find a dentist that will even help me.

    Because of all of this, it’s my opinion that if this medication (dissolving Buprenorphine) causes and/or exacerbates dental issues, that’s a huge issue in and of itself. People should be abundantly cautious about taking it due to the problems that can arise from that alone. My oral health issues are not from taking opioid medications but everyone that I’ve seen seems to want to believe otherwise. I can’t imagine how it might be for someone that did have substance abuse issues or one of the many chronic pain patients that have been forced off onto addiction medication, if it causes an oral health disaster for them. They’d be in the position that I’m now in.

    My experience has been that far too many people would rather believe the tropes about bad teeth and drug abuse than listen to reason. Ironically, the dentist that called me a junkie has a bunch of awards for his humanitarian dental work. I naively thought that I could go to him for judgement free dentistry due to this. He thought that I came there to get free dental work because I’m a drug addict and told me as much. My spouse was making good money at the time and we were prepared to pay for the work. Instead, he refused to listen to what I was trying to tell him and then booted me out of his office, threatening to demand that my doctor cut me off of my medication or that be would turn them in. He’s the real reason that my teeth have gotten as bad as they are now. I’m afraid to go to another dentist, what if they think the same way? What if the get me cut off or have my doctor investigated over what they THINK is going on, as opposed to the reality of the situation?

    This has all gotten way too out of control. Once upon a time, if something like this happened, you could just show evidence of having been seriously ill as well as whatever else supported the reasoning behind something like deteriorating dental health, and common sense would have prevailed. Not anymore. All you have to do is accuse a doctor of wrongdoing, even if it’s only due to your own errant beliefs or ignorance and the doctor will end up paying for it. Such a twisted society we live in and getting more twisted by the day. It gets so old. So very, very tiresome.

    I wouldn’t blame anyone that didn’t want to take this medication just because of the oral health issues. Once that happens, you will likely be treated like absolute garbage by a large portion of the community, including but not limited to those that are supposed to be there to help. No one should be treated like garbage for trying to get HELP.

    Small wonder people end up toothless, without implants or dentures. Sure those things are expensive, but the bigger expense is being expected to put up with being assailed with a constant barrage of derogatory remarks and threats, as a tradeoff for having your teeth worked on. I know that there are many dental offices that claim to be “judgement free” these days but it would be taking a risk to assume that they take that statement seriously, since it could mean facing the loss of my doctor and treatment for chronic pain if they do not. With the so-called opioid epidemic raging on, you never know. They’re all on board with saving us to death these days.

    • As he was explaining why he said he would not fix them he mentioned that “street drugs will cause that”. He had zero reason to accuse me of using street drugs. He already knew I was an abandoned severe pain sufferer and was even helping with the effort to recover the Opiates. He didn’t have a reason.
      I think he wanted me to hate him enough not to come back. He finished with “see you in July”. I didn’t make a rukus for any of it because I will have to see him well before July to pull the teeth he will not fix. On his side he had been hinting for quite a while before this that he only does simple stuff. I must assume its the only reason he takes Medicaid Pts. at all. Cleaning and pulling, that’s all. But he DID tell me he would fix them at the cleaning/exam before last.

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