Suboxone, a medication commonly prescribed for opioid addiction, has recently come under scrutiny for its potential to cause serious dental problems in patients. One individual, David Sorensen, recently filed a product liability lawsuit against the manufacturers of Suboxone, claiming that the opioid addiction drug’s high acidity caused him to suffer tooth decay and permanent dental damage. The lawsuit was filed in the U.S. District Court for the Northern District of Ohio on September 25, 2023, and names as defendants Indivior, Aquestive Therapeutics, MonoSol Rx, and Reckitt Benckiser.
What is Suboxone?
Suboxone is a prescription medication used to treat opioid addiction. It combines two drugs, buprenorphine and naloxone, to help individuals manage cravings and withdrawal symptoms during the recovery process. Buprenorphine is a partial opioid agonist that helps reduce withdrawal symptoms, while naloxone is an opioid antagonist that blocks the effects of opioids. Prescription Suboxone is available in two forms – a tablet and a sublingual film designed to be dissolved in the mouth. It is important to note that Suboxone should not be the sole element of an opioid addiction recovery plan but rather used in combination with counseling and regular primary care.
Link Between Suboxone and Dental Problems
Recent studies and reports have suggested a potential link between Suboxone use and dental problems, including tooth decay, cavities, oral infections, and tooth loss. The acidic nature of Suboxone, particularly the sublingual films and tablets meant to be dissolved in the mouth, may contribute to these dental issues. Patients who have used Suboxone for an extended period have reported experiencing severe dental problems, including the need for tooth extractions and extensive dental treatments.
Lawsuits Alleging Dental Injuries from Suboxone
According to David Sorensen’s lawsuit, he was prescribed Suboxone after becoming addicted to opioid drugs he took for pain management. Sorensen states in his complaint that his use of Suboxone caused him to suffer permanent tooth decay resulting in the need for extensive dental work. The product liability lawsuit alleges that manufacturers Indivior, Aquestive Therapeutics, MonoSol Rx, and Reckitt Benckiser were aware of the risks of tooth decay associated with Suboxone long before the FDA required new label warnings in 2022. By the end of 2010, the manufacturer had submitted to the FDA nearly two dozen reports of dental issues occurring in patients taking Suboxone.
Suboxone Research Studies and FDA Warning
In early January 2022, the FDA issued a drug safety communication highlighting more than 300 reports of tooth decay and dental problems (131 of which were considered serious) among patients treated with buprenorphine-containing drugs, including Suboxone. These dental problems have been observed in patients as young as 18 years old and in those with no prior history of dental issues. The FDA mandated a new warning about the risk of dental problems to be added to the prescribing information and patient medication guide for all buprenorphine-containing drugs dissolved in the mouth. The FDA also noted in the warning that “Dentists treating someone taking a transmucosal buprenorphine product should perform a baseline dental evaluation and caries risk assessment, establish a dental caries preventive plan, and encourage regular dental checkups.”
Seeking Compensation for Dental Injuries
The Suboxone lawsuit filed by David Sorensen is one of the first claims to be filed alleging a link between Suboxone use and tooth decay. As more information emerges about the potential dental injuries associated with Suboxone, additional lawsuits will likely be filed against the manufacturers. These lawsuits may include allegations that the manufacturers failed to adequately warn patients and healthcare professionals about the risks associated with Suboxone use, resulting in avoidable dental injuries.
In light of emerging information about the potential risk of dental injuries from Suboxone, individuals who have suffered severe tooth decay, tooth loss, or other side effects allegedly caused by Suboxone use may be eligible to pursue legal action against the manufacturers. Compensation sought through Suboxone lawsuits may include medical expenses, pain and suffering, loss of income, future dental care, and punitive damages.
Additional Suboxone Lawsuits Expected
David Sorensen’s lawsuit against the manufacturers of Suboxone highlights the potential risk of serious dental problems, including tooth decay, cavities, oral infections, and tooth loss, associated with the opioid use disorder drug. Sorensen is seeking compensatory and punitive damages plus attorney fees, according to the complaint. As more individuals come forward with similar dental injuries, it is expected that additional lawsuits will be filed against the maker of Suboxone.
Suboxone Lawsuit Information
Statement from SAMHSA Leader on FDA’s Drug Safety Alert on Buprenorphine and Risk for Tooth Decay, SAMHSA