A peer-reviewed journal that offers evidence-based clinical information and continuing education for dentists.

Legal Fight Over Suboxone’s Detrimental Effects on Oral Health Continues


The Suboxone dental issue has sparked a series of lawsuits, with plaintiffs alleging that the manufacturers failed to adequately warn about the risk of severe dental caries and other oral health problems associated with the drug. Developed as an opioid addiction treatment, Suboxone gained United States Food and Drug Administration (FDA) approval in 2002, presenting hope amidst the opioid crisis. Composed of buprenorphine and naloxone, it aimed to reduce misuse while alleviating withdrawal symptoms. Studies from 2012 and 2013 highlighted patients experiencing dental deterioration while using Suboxone, indicating a potential link between the medication and severe dental caries. Subsequent investigations revealed the drug’s acidic nature, with a pH level of 3.4 when dissolved, posing risks to tooth enamel integrity. Despite mounting evidence, Suboxone’s original labels lacked warnings about oral health risks. Only in 2022 did the FDA mandate a warning about potential dental issues associated with Suboxone use. This delayed action has led to accusations of negligence and lack of transparency on the part of drug manufacturers. The lawsuits argue that manufacturers knowingly disregarded the dental health risks of Suboxone, failing to update warning labels until prompted by regulatory intervention. The legal proceedings underscore the responsibility of pharmaceutical companies to provide comprehensive information to patients, enabling informed decisions about treatment. Click here to read more.

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