The medication commonly found in Suboxone, used to treat opioid addiction, has had remarkable success in helping many overcome dependence. However, it may come with an unexpected cost, as the U.S. Food and Drug Administration is now warning of hidden dangers lurking in your mouth.
Dental problems have emerged as an alarming side effect of buprenorphine, the active ingredient in Suboxone. Now, the FDA is shedding light on this issue, leaving many wondering how their prescription could compromise their oral health.
In this article, we will explore the specific dental problems linked to buprenorphine and examine the FDA’s warning in more depth.
Opioid Overdose Deaths in the United States
The United States faced a severe public health crisis in 2022, with drug overdoses claiming 107,941 lives. As per the CDC, this translates to an age-adjusted mortality rate of 32.6 per 100,000 individuals. The gravity of this issue becomes apparent when examining historical data: two decades earlier, in 2002, the rate stood at 8.2 deaths per 100,000. This marks a nearly fourfold increase over the 20-year period.
Between 2021 and 2022, the rate of drug overdose deaths increased slightly (1.1%) for males from 45.1 to 45.6 deaths per 100,000. For females, the rate decreased slightly (1.0%) from 19.6 to 19.4 deaths per 100,000, but this decrease was not statistically significant.
Buprenorphine for Opioid Dependence
For individuals struggling with dependency on opioid substances, including illicit drugs like heroin or prescribed pain medications, there’s a therapeutic option called buprenorphine.
This medication aids in managing the intense urges and uncomfortable withdrawal effects associated with opioid dependence. Its effectiveness stems from its interaction with the brain’s opioid receptors, mimicking the action of opioids themselves.
When buprenorphine replaces other opioids, it helps lessen withdrawal symptoms and cravings. This makes it easier for individuals to stop harmful drug use and focus on recovery.
Moreover, buprenorphine comes in several formulations, including sublingual tablets or films placed under the tongue, transdermal patches applied to the skin, and extended-release injections. These different options provide flexible dosing to meet a person’s individual needs.
Buprenorphine and Dental Health
The FDA has identified potential dental side effects related to the use of buprenorphine medications that are dissolved in the mouth. Of over 300 cases reported since its approval for opioid use disorder, more than 130 involved serious oral health issues.
Most cases involved patients using buprenorphine to treat opioid use disorder. The data indicates dental problems can affect people of all ages. When reviewing dental records, 26 patients out of 305 reported no previous dental problems. Over 100 patients said two or more teeth were impacted after starting buprenorphine treatment. Problems manifested anywhere from two weeks to years later in some cases.
Healthcare providers also submitted a high number of adverse event reports related to buprenorphine’s effects on oral health. According to the FDA, tooth extraction or removal was the most common treatment prescribed for these issues, with over 70 cases. Other dental procedures like root canals, surgery, and restorative treatments such as crowns and implants were also required in some cases.
Victims Are Filing Suboxone Lawsuit
Many individuals who experienced dental problems after using Suboxone films (Buprenorphine/Naloxone) are filing product liability lawsuits against the manufacturer. This Suboxone lawsuit claims that the drug caused severe tooth decay and other oral injuries. They also state that the company failed to warn doctors and patients adequately about these potential side effects.
According to TorHoerman Law, drug companies have a legal duty to disclose all known risks associated with their products. Plaintiffs argue that Indivior, the maker of Suboxone, did not provide warnings about dental risks until recently, despite potential issues being known for years.
The federal Suboxone lawsuits are being combined into a multidistrict litigation (MDL) proceeding in the Northern District of Ohio. This consolidation is due to the shared factual issues among the cases. The MDL process enables a single court to manage numerous related lawsuits more effectively, streamlining the legal proceedings.
As per Drugwatch, legal representatives for the plaintiffs took action in November 2023, approaching the Judicial Panel on MDL with a request. They sought to consolidate all federal lawsuits related to dental harm allegedly caused by Suboxone into a single, coordinated legal proceeding.
At that time, over a dozen new lawsuits related to these dental issues had been filed against Indivior. These legal actions were brought before several federal courts across the nation. The Northern District of Ohio was noted to have one of the higher numbers of suits currently pending.
By consolidating the Suboxone dental injury cases through MDL, it is hoped the legal process can move forward more smoothly.
FAQs
1. Can I sue Suboxone for damaging my teeth?
You might qualify to file a lawsuit for Suboxone-related tooth decay if you were prescribed Suboxone film or tablets and experienced significant dental issues. This is especially relevant if you were not informed about the risk of dental injuries associated with the medication.
2. Is buprenorphine being discontinued?
Based on available information, buprenorphine has not been removed from the market even with concerns about its safety or effectiveness. As a result, the regulatory agency will maintain the listing for BUPRENEX (buprenorphine hydrochloride) Injection, at a concentration of 0.3 mg/mL, within the Orange Book’s section dedicated to discontinued drug products.
3. How strong is buprenorphine?
At low to moderate doses, the opioid partial agonist buprenorphine can have euphoric and respiratory depressant effects. Still, these effects pale in comparison to those of complete opioid agonists, such as heroin and methadone. When used as prescribed, buprenorphine is both safe and effective.
In the end, the link between buprenorphine and dental problems sheds light on an important but invisible cost of opioid addiction treatment. The FDA warning confirms that oral health should not be overlooked, even when taking medications that save lives. For those grappling with the aftermath of dental injuries, pursuing legal remedies through lawsuits holds companies accountable for undisclosed risks.
Only by bringing overlooked issues to light can patients make informed choices about their treatment options and well-being. The years-long toll of dental problems also underscores the intricate, long-term nature of recovery – both physical and mental.
