More Plaintiffs Filing Lawsuits Claiming Suboxone Caused Tooth Decay

Global pharmaceutical company Invidior, which makes a drug called Suboxone (buprenorphine), is defending an increasing number of lawsuits concerning the safety of the drug. Suboxone helps patients who are addicted to opioids to end their addiction, but plaintiffs claim it also causes tooth decay and other dental injuries. Invidior Develops Suboxone Film to Preserve Monopoly Profits

Invidior was one of the companies that developed a new drug to treat opioid addiction. Buprenorphine is a synthetic (man-made) opioid that treats acute pain, chronic pain, and opioid use disorder.

First developed in the 1960s, it helps reduce cravings and withdrawal symptoms. It may be administered via a transdermal patch, or orally via sublingual tablets or a buccal film (a film you place in your mouth and allow to dissolve). It can also be placed underneath the skin or administered through injections.

Invidior—then known as Reckitt—developed two buprenorphine products to treat opioid addiction, one of which was Suboxone. The FDA approved Suboxone tablets in 2002 to manage opioid dependence. Invidior’s exclusivity with the drug ran out in October 2009. After that date, other companies could create generic forms.

To help continue their profits, Invidior developed a Suboxone sublingual film—a product that would deliver the same medication, but in a different way.

The FDA approved the application for this new form of the drug on August 30, 2010. Invidior proceeded to heavily market the new film application, encouraging doctors to prescribe it versus the generic tablets.

Patients Report Dental Problems with Suboxone

In 2012, Harvard Medical School professors published a case report on a patient who suffered oral health problems—including extensive tooth decay—while using Suboxone. In 2013, they published a case series of 11 patients who suffered worsening oral health after they started to take buprenorphine.

The U.S. Food and Drug Administration (FDA) also received many reports of patients taking Suboxone and then suffering from symptoms like the following:

• Tooth loss
• Cavities and tooth decay
• Toothaches
• Oral infections
• Dry mouth
• Jaw pain
• Swollen tongue

Epidemiological studies have shown an association between the use of Suboxone and dental erosion and decay. According to one published in December 2022—which involved over 30,000 users of buprenorphine—there was an increase in the risk of adverse dental outcomes associated with the sublingual version as opposed to the transdermal version, or an alternative drug (naltrexone).

On January 12, 2022, the FDA warned about dental problems with buprenorphine medications dissolved in the mouth to treat opioid use disorder and pain: “The dental problems,” the FDA wrote, “including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.”

The administration required a new warning about the risk of dental problems be added to the prescribing information and medication guides for all such medications.

Prior to that, despite being aware of the many reports of dental issues, Invidior made no effort to warn consumers of the dangers.

Plaintiffs File Claims Stating that Invidior Was Negligent

As the public became more aware of the connection between oral problems and Suboxone, plaintiffs began to file lawsuits against Invidior. They allege that the manufacturer was negligent in developing, designing, testing, labeling, and advertising the product, and that the company failed to adequately warn patients of the danger.

Invidior has faced other legal challenges as well. As just one example, in 2016, 41 states and the District of Columbia sued Invidior for antitrust violations related to boxing out competitors from the opioid-addiction treatment market. That cause was recently resolved, with Invidior agreeing to pay $102.5 million.