Suboxone Dental Side Effects Caused Permanent Damage to Teeth, Lawsuit Claims

Plaintiff suffered severe tooth damage from Suboxone, which required substantial work to repair the dental side effects, according to the complaint.

An Ohio woman says she suffered permanent damage to her teeth due to dental side effects of Suboxone, indicating that the drug maker withheld critical warnings from users and the medical community about the drug’s high acidity and risk of tooth decay.

The complaint (PDF) was filed this week by Teresita Badalamenti in the U.S. District Court for the District of Northern Ohio, pursuing financial damages from Suboxone’s manufacturers, Indivior, Inc., as well as Aquestive Therapeutics, MonoSol, RX, Inc., and Reckitt Benkiser, LLC.

Suboxone (buprenorphine and naloxone) was a drug first approved in 2002 to treat recovering opioid addicts; helping them avoid withdrawal symptoms while they undergo therapy to help them break their addiction.

In January 2022, the FDA issued a warning about the risk of Suboxone dental side effects, following more than 300 reports involving tooth decay and tooth loss linked to buprenorphine drugs, most commonly involving users in their 40s. However, problems were also seen among those as young as 18 years old, with some of the dental damage from Suboxone reported as soon as two weeks after beginning treatment.

Later that year, the FDA ordered an update to the prescribing information for all buprenorphine products designed to dissolve in the mouth, including Suboxone films and tablets. However, Badalamenti and a number of other former users are now pursuing Suboxone tooth decay lawsuits against Indivior, alleging that it knew or should have known about the dental side effects long before warnings were added by the FDA.

Badalamenti indicates that she was prescribed Suboxone after she became addicted to opioids, as a result of using the medications for pain management. Neither she nor her doctors were warned about possible tooth decay and damage, the lawsuit indicates.

Similar to allegations raised in other recently filed Suboxone tooth decay lawsuits, Badalamenti claims she suffered permanent tooth damage due to Suboxone side effects, and has needed substantial dental work to repair the problems.

Baldalamenti points to numerous incident reports received by Indivior for years before the 2022 Suboxone warning label update, as well as studies and case reports published in medical literature, which the lawsuit indicates make it clear the drug maker was aware of the risk of Suboxone dental damage, but placed a desire for profits before consumers safety.

“Of the adverse events reported to FDA before the mandated label change, 40% were classified as serious. Over one-third reported the problem as affecting two or more teeth,” the lawsuit states. “Some of the adverse events were reported in patients with no prior history of dental issues.”

Suboxone Deceptive Marketing Claims

Originally designed as a dissolving pill, Indivior allegedly waited until its patent exclusivity expired before introducing Suboxone film versions in 2009, which have been linked to the greatest risk of dental side effects. Baldalamenti claims the introduction of Suboxone film, which is placed under the tongue and rapidly introduced in the patient’s blood stream, was actually done to avoid generic competition and extend patent protections, not to benefit patients.

The states and federal government accused the manufacturer of submitting a fraudulent petition to the FDA in September 2012, which claimed the Suboxone Tablet had to be discontinued due to safety concerns. However, regulators determined that, in actuality, the manufacturer sought to control supply and improperly inflate Suboxone pricing, including what state Medicaid programs paid for it.

In 2019, Reckitt Benckiser Pharmaceuticals reached a $700 million settlement with the federal government and states over Suboxone Medicaid fraud allegations. Indivior spun off from the company shortly afterwards and reached a $600 million Suboxone settlement agreement with the Justice Department in 2020, to resolve claims of aggressive and deceptive marketing. Then, in 2021, the company agreed to pay another $300 million to settle similar claims filed by all 50 states and the District of Columbia.