What is Zubsolv?
Zubsolv is a combination of 2 medicines, buprenorphine and naloxone, which are used to treat opioid use disorder (OUD). Buprenorphine works by helping to prevent withdrawal symptoms caused by stopping other opioids, while naloxone is an opioid antagonist that blocks the effect of opioids. Zubsolv is manufactured and marketed by Orexo, and was approved by the U.S. Food and Drug Administration (FDA) on July 3, 2013.
FDA Warns About Dental Problems with Zubsolv
The FDA [1.] on Jan. 12, 2022, warned that dental problems have been reported in patients using tablets and films that contain buprenorphine (one of the active ingredients contained in Zubsolv). These problems have included tooth decay, cavities, oral infections and loss of teeth. FDA noted that these dental problems can be serious and have occurred in people with no history of dental issues.
Zubsolv Side Effects
Serious dental side effects of Zubsolv include:
- Tooth decay
- Cracked teeth
- Oral infections
- Tooth loss
- Dental Caries (loss of enamel, dentine, and other tooth substances)
- Root canal
- Tooth extraction
- Crown replacement
Zubsolv Tooth Decay Studies
A December 2022 study published in JAMA [2.] examined the occurrence of dental adverse events associated with sublingual buprenorphine-naloxone exposure.
The authors gathered a cohort of patients who were registered in the PharMetrics database (IQVIA), and divided them into groups of new users of sublingual buprenorphine-naloxone and 2 active comparator groups (used for opioid use disorder) -- new users of either transdermal buprenorphine or oral naltrexone. A total of 21, 404 new users of sublingual buprenorphine/naloxone, 5,385 users of transdermal buprenorphine, and 6,616 users of oral naltrexone were included in the study.
The findings suggested an increase in the risk of adverse dental outcomes linked to sublingual buprenorphine/naloxone compared with transdermal buprenorphine and oral naltrexone. Sublingual buprenorphine/naloxone is acidic in nature, so the researchers concluded that prolonged acidic exposure of buprenorphine in the mouth could lead to tooth decay.
Another study published in The Primary Care Companion [3.] in Oct. 2013 looked at a cohort of 11 patients who were prescribed buprenorphine and subsequently reported worsening dental health after treatment initiation. All of the participants encountered dental problems including cavities, dental fillings, cracked teeth, crown replacements, root canals, and tooth extractions. The researchers concluded that dental cavities and tooth erosion occur in environments with low pH levels.
What You Can Do if You are Taking Zubsolv
If you are currently taking Zubsolv or another buprenorphine-containing product that is dissolved in the mouth, you should continue taking it as prescribed. The benefits of taking such medications for the treatment of opioid-use disorder outweigh their risks, according to the FDA. Suddenly quitting Zubsolv can cause severe withdrawal symptoms or relapse of opioid misuse, which could result in overdose and death.
Other Zubsolv Side Effects
In addition to increasing the risk of tooth decay and other dental problems, Zubsolv has been linked to other serious side effects including:
- Trouble breathing
- Sleepiness, dizziness, and problems with coordination
- Physical dependence or abuse
- Liver problems
- Allergic reaction
- Opioid withdrawal
- Decrease in blood pressure
Get a Free Zubsolv Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zubsolv Lawsuits. We are handling individual litigation nationwide and are currently accepting new dental Zubsolv Side Effects cases in all 50 states.
Again, if you or a loved one experienced tooth decay after using Zubsolv, or suffered from other dental Zubsolv side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and our lawyers can help.