A recent lawsuit filed in Ohio against various pharmaceutical companies has opened up a new area of consumer concern and litigation—Suboxone, a drug commonly prescribed to treat opioid addiction, is now under scrutiny for causing serious dental issues. The lawsuit alleges that Suboxone, when used as prescribed, can cause permanent damage to teeth due to its acidity.
David Sorensen, a resident of Cuyahoga County, Ohio, has filed a lawsuit for damages caused by Suboxone, the drug that he was prescribed to help him manage his opioid addiction. According to the lawsuit, Suboxone has led to “permanent damage to Plaintiff’s teeth.”
The pharmaceutical companies named as defendants in the lawsuit are Indivior Inc., Indivior PLC, Indivior Solutions Inc., Aquestive Therapeutics Inc., MonoSol Rx Inc., MonoSol LLC, Reckitt Benckiser LLC, and Reckitt Benckiser Healthcare (UK) Ltd.
The complaint suggests that the defendant companies were, or should have been, aware that Suboxone can lead to dental erosion and decay but failed to adequately warn consumers and healthcare providers. It points out that as of early 2022, the FDA had already issued a Drug Safety Communication warning about the dental risks associated with medications containing buprenorphine, the active ingredient in Suboxone. However, the medication guide for Suboxone did not include these warnings.
The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication in January 2022 warning of dental problems linked to buprenorphine-based medicines dissolved in the mouth. By June 2022, the defendants updated the Suboxone prescribing information to warn about dental issues but did not change the medication guide.
The lawsuit alleges that even though the FDA required a new warning about dental risks to be added to the prescribing information, no such warning was made part of the medication guide. This raises concerns about whether or not consumers and healthcare providers are fully informed about the risks associated with Suboxone.
The opioid crisis has been a colossal public health disaster, and pharmaceutical companies have faced a barrage of lawsuits related to the over-promotion and over-prescription of opioids. What makes this case especially intriguing is that it deals with a drug intended to be part of the solution to the opioid crisis, yet is alleged to have harmful side effects of its own.
Moreover, the lawsuit alleges that the pharmaceutical companies have profited not only from the crisis but also from the medication designed to treat it, thus benefiting from the full cycle of addiction and treatment.
This case could have significant implications for the regulation of medications intended to treat opioid use disorder. It may also serve as a precedent for future lawsuits targeting drugs intended to treat addiction but which may have their own harmful side effects. Consumers who have been prescribed Suboxone, especially those who have experienced dental problems, should be aware of this ongoing legal action.
It’s important to note that while this lawsuit raises concerns about Suboxone and similar medications, it is currently a legal claim that has not been proven in court. Consumers should consult with their healthcare providers for medical advice.
The lawsuit against the manufacturers of Suboxone opens up a new avenue of discourse and accountability in the ongoing struggles to tackle the opioid crisis in America. While the litigation is still in its early stages, the outcome could have far-reaching consequences for pharmaceutical companies and consumers alike.