A panel of federal judges is set to convene in California on January 25, 2024, to hear oral arguments regarding the consolidation of 15 Suboxone tooth decay lawsuits into multidistrict litigation (MDL). This decision comes following a joint motion by plaintiffs’ attorneys and the drug’s manufacturer, Indivior, seeking coordinated discovery and pretrial proceedings.
Background Leading to Suboxone Lawsuits
Some individuals have reported experiencing dental side effects, such as tooth decay and loss, after using Suboxone, leading to lawsuits alleging that Indivior failed to adequately warn users of these risks. These injuries have prompted legal action against the manufacturer.
Suboxone, approved by the U.S. Food and Drug Administration (FDA) in 2002 for treating opioid addiction, was initially available only in tablet form. Later, Indivior introduced Suboxone film, designed to dissolve beneath the tongue for easier administration.
The acidic nature of the Suboxone film has been associated with dental injuries, particularly with prolonged use. In early 2022, the company added warnings about tooth decay associated with Suboxone use following the FDA’s identification of over 300 reports of dental problems linked to the drug.
FDA Warning and Recommendations
In response to these concerns, the FDA issued a Drug Safety Communication advising both prescribers and users of Suboxone to focus on oral health strategies when using the film version of the drug. The communication highlighted the seriousness of dental problems associated with Suboxone use, including tooth decay, cavities, oral infections, and tooth loss, even in individuals with no prior history of dental issues.
The FDA recommends that prescribers refer patients to dental care services and encourage them to undergo regular checkups while taking Suboxone. These proactive measures aim to address and mitigate potential dental complications associated with Suboxone use.
