FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
Benefits for use outweigh these risks and oral care can help
The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues. Despite these risks, buprenorphine is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks.
Regular adherence to buprenorphine to treat OUD reduces withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse. The comprehensive approach of buprenorphine combined with counseling and other behavioral therapies is often one of the most effective ways to treat OUD. This approach, called medication-assisted treatment (MAT), is tailored to meet each patient’s needs and can help sustain recovery and prevent or reduce opioid overdose. According to the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), MAT has been shown to be effective in improving patient survival, decreasing opioid use, and allowing patients to live a self-directed life, including the ability to gain and maintain employment.
Since buprenorphine was approved, we identified 305 cases of dental problems (131 cases classified as serious) with buprenorphine medicines dissolved in the mouth. These only include cases reported to FDA* or published in the medical literature,1,2 so there may be additional cases about which we are unaware. The average age of the patients was 42 years, but those as young as 18 years were also affected. Most cases were 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 cases reported dental problems occurring as soon as 2 weeks after treatment began, with the median time to diagnosis being approximately 2 years after starting treatment. Many cases were reported by health care professionals and provided documentation of extensive dental adverse events. Of the 305 cases, 113 mentioned two or more teeth were affected. The most common treatment for these dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases reported requiring root canals, dental surgery, and other procedures such as crowns and implants.
*The cases were reported to the FDA Adverse Event Reporting System (FAERS) database.
Buprenorphine-containing medicines that are dissolved in the mouth are approved to treat opioid use disorder (OUD), and one product is approved to treat pain. These medicines are available as tablets and films to be placed under the tongue or on the inside of the cheek and kept there until completely dissolved.
These medicines are available as single-ingredient products and in combination with naloxone. Buprenorphine medicines are marketed under the brand names Belbuca, Bunavail, Cassipa, Suboxone, Subutex, and Zubsolv. They are also available as generics.
Buprenorphine is an opioid and works by changing the way the brain and nervous system respond to pain.
In patients taking buprenorphine for OUD, it reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid use less appealing. When combined with counseling and other behavioral therapies, this comprehensive medication-assisted treatment (MAT) approach is often the most effective way for treating OUD. It can help sustain recovery and prevent or reduce opioid overdose.
Common side effects of buprenorphine include headache, nausea, vomiting, constipation, pain, increased sweating, and insomnia.
The use of buprenorphine-containing medicines that are dissolved in the mouth has been growing. The estimated number of prescriptions dispensed from U.S. outpatient retail and mail-order pharmacies increased from 11 million in 2014 to 16 million in 2020
A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature1,2 through December 31, 2018, identified 305 cases of dental adverse events reported with transmucosal buprenorphine use. Patients with opioid use disorder (OUD) may have a higher incidence of poor dental health;4 however, many cases described severe dental issues in patients with no reported prior history of dental problems (n=26). In addition, although most of the cases were in patients using transmucosal buprenorphine products for OUD, there was a subset of patients (n=28) who experienced severe dental adverse events while receiving pain-only indicated products (e.g., Belbuca) or stated the indication was for pain.
The average age of the patients in this case series was 41.8 years (range 18-71), and the median time to diagnosis was 24.25 months (range 0.5-182). Many cases reported a combination of dental decay, tooth loss, and tooth fractures in numerous teeth. Many cases were reported by health care professionals and provided documentation of extensive dental adverse events including “all upper,” “all lower,” “all,” “majority,” “most,” “multiple teeth,” and “rampant decay.” The cases often noted the number of teeth involved, with 113 cases mentioning two or more teeth. Some cases specifically mentioned involvement of 11 to 12 or more teeth, as well as all teeth in 11 cases. Of the 305 cases, 151 reported the treatment for the adverse event, with tooth extraction/removal as the most common, which was reported in 71 cases. Other treatments included root canal, dental surgery, and other restorative procedures such as crowns and implants.
Provision Consulting Group provides consulting service and solves customer problems accurately and quickly.
Our services allow manufacturers to spend more time developing their devices
rather than searching for distributors, negotiating contracts, and learning regulations.
If you have questions about FDA regulation of medical devices
or importing of medical devices to the United States,
please CONTACT US.
Office 1-909-493-3276
Email ask@provisionfda.com
SOURCE :