Have you ever wondered about the unexpected side effects of certain medications? Take Suboxone, for example. Widely used in opioid addiction treatment, this drug has recently been under scrutiny for an unusual reason: tooth decay. This startling side effect has not only raised eyebrows but has also led to a series of Suboxone lawsuits.
In this blog, we’ll dive into the surprising connection between Suboxone and dental health, unraveling a medical mystery that’s as interesting as it is concerning. Stay tuned as we explore how Suboxone, which is meant to heal patients inadvertently causes harm, that is the root cause for Suboxone lawsuits 2023-2024.
Before diving deep into the Suboxone side effects, let’s understand the chemical components of the drug and how it works.
What is Suboxone?
Suboxone is a Schedule III prescription drug with a combination of two key ingredients named buprenorphine and naloxone. Which company owns Suboxone? Indivior, a Richmond, Virginia-based American company, manufactures and distributes brand-name Suboxone products.
Is Suboxone FDA approved?
What is the FDA approved use of Suboxone?
The drug is FDA-approved for addiction treatment to those suffering from Opioid use disorder (OUD).
Buprenorphine is a partial opioid agonist, which means it produces a milder form of the effects that typical opioids do, helping to alleviate withdrawal symptoms and cravings.
Naloxone, on the other hand, is an opioid antagonist that counters the effects of opioids in the system, especially in cases of overdose. Naloxone competes with opioid molecules and prevents them from binding to the opioid receptors. This combination makes Suboxone an effective tool in the management of opioid dependence.
Coming to the history of Suboxone, Subutex was the brand name for the initial buprenorphine formulation intended for treating addiction. Instead of the current Suboxone formulation, which combines buprenorphine and naloxone, it exclusively contained buprenorphine.
Because of its pure buprenorphine content, Subutex was quickly altered, as users tried abusing the drug by injecting it to get high. In order to prevent that, pharmacists developed a combination medication including naloxone, which will be activated if a user tries to inject Suboxone to get high. The effects of buprenorphine would be inhibited, so the user is not able to become high or overdose.
Currently Suboxone is available in the market in four strengths. They are:
- 2 milligrams (mg) buprenorphine / 0.5 mg naloxone
- 4 mg buprenorphine / 1 mg naloxone
- 8 mg buprenorphine / 2 mg naloxone
- 12 mg buprenorphine / 3 mg naloxone
Administration of Suboxone
The way Suboxone is administered is a key part of its effectiveness. The medication is administered under the tongue (sublingual) or inside the cheek (buccal). This method ensures that naloxone doesn’t counteract buprenorphine’s effects unless the medication is injected, a safeguard against misuse.
Sublingual Film® (CIII) is frequently used in conjunction with behavioral therapy and counseling in medication-assisted treatment (MAT) for opioid addiction. MAT programs provide a “whole-patient” approach, increasing the rate of sobriety, reduce the risk of overdose, and help individuals lead more stable lives.
Suboxone Effects in the Brain
Suboxone’s effects are mediated through strong binding to the same brain receptors as heroin, morphine, and oxycodone. This reduces cravings, lessens the effects of intoxication from these other drugs, and aids in many people’s transition from a life of addiction to one that is secure and normal.
Before taking Suboxone, the individual should be away from Opiates for atleast 12-24 hours. This would help to prevent severe withdrawal symptoms due to the presence of Naloxone in the medication. Suboxone can be used to help with withdrawal symptoms after the first 24 hours of opioid withdrawal. After starting Suboxone, a person may feel “back to normal” in a few days or hours, depending on their usage history.
When withdrawal symptoms are at a level that is medically safe, the doctor will discuss treatment options and gradually lower the drug’s dosage until a full detox is achieved.
Side Effects of Suboxone
Suboxone is reported to have mild to serious side effects, which are discussed as follows.
- Dizziness and fainting
- Opioid withdrawal syndrome
- Blurred vision and slurred speech
- Unusual and slow breathing
- Allergic reactions like rashes, swelling of face
The current injury lawsuits pertaining to Suboxone assert that Indivior did not appropriately warn against Suboxone’s potential to cause dental issues. Suboxone tooth decay lawsuit started to boom when the users started to develop oral and dental issues like cavities, infections, tooth decay, and loss of teeth.
On September 25, 2023, David Sorensen filed a Suboxone product liability lawsuit in the U.S. District Court for the Northern District of Ohio. The defendants in the Suboxone tooth decay claims were Indivior, Aquestive Therapeutics, MonoSol Rx, and Beckitt Benckiser. Sorenson, the plaintiff in the Suboxone lawsuit, claimed he suffered from permanent tooth decay that demanded prolonged and expensive dental treatment.
On October 16, 2023, another plaintiff from Geauga County, field another Suboxone tooth decay lawsuit. According to the lawsuit, the plaintiff was prescribed Suboxone to treat his Opioid addiction. After 16 months of use, the plaintiff began to sustain severe tooth decay, requiring several permanent teeth extractions.
As per both the lawsuits, the drug manufacturers knew that Suboxone, when used as prescribed and intended, causes harmful damage to the teeth due to the acidity of buprenorphine.
There is a strong base for this argument of the plaintiffs in Suboxone lawsuits 2023. Let’s check it out.
The Food and Drug Administration (FDA) issued a warning on January 12, 2022, stating that patients who take films and tablets containing buprenorphine by dissolving them in their mouths have reported dental issues. The warning stated that extended exposure to Suboxone can weaken tooth enamel and cause dental issues such as cavities, gum disease, and even tooth loss. This is due to the acidic nature of buprenorphine.
As per the FDA, more than 300 cases of tooth decay and loss and oral infections had been reported and the list included patients with no history of oral health issues. The FDA ordered the manufacturers of this group of drugs to update the prescribing information with dental risks. This list also included Suboxone films and tablets.
Suboxone Tooth Decay Lawsuits 2023
As of November 3, 2023, 14 new Suboxone lawsuits have been filed in federal courts against Indivior. As of now, Suboxone tooth decay litigation have not yet been consolidated into a class action lawsuit or MDL.
However, as per the Suboxone lawsuit lawyers, Suboxone lawsuits 2024 will be one of the biggest product liability lawsuits in the United States, considering the massive opioid addiction cases and medications used against that.
Apart from the blossoming product liability cases brought by victims with dental decay, the manufacturer of Suboxone is also being sued under the False Claims Act for allegedly defrauding the federal government.
The drug manufacturer is also facing another lawsuit, facing allegations that the company’s dissolving film version of Suboxone was created only to suppress competition from generic Suboxone once the original patent expired. In this lawsuit, Indivior has agreed to pay $385 million in October 2023. The company had already settled comparable government claims for $900 million.
Who can file a Suboxone tooth decay lawsuit?
Any individual can file a Suboxone lawsuit for dental decay under the following circumstances.
- The individual should have been prescribed Suboxone for pain relief or opioid addiction.
- The individual should have used Suboxone for at least six months prior to experiencing side effects.
- The individual possess one or more of the injuries including cavities, lost or broken teeth, dental decay, fractured teeth, tongue injuries, and gum injuries.
- The individual should have had regular dental care before using suboxone.
Suboxone Lawsuit 2023 Payout per Person
Suboxone tooth decay lawsuits are still in the cradle and the discovery phase for any of the lawsuits has not yet started. At this point of time, it’s hard to assume the payout. However, Suboxone lawsuit attorneys expect that successful claims with valid proof can fetch a jury payout between $500,000 -$1 million.
The settlement amount for Suboxone lawsuits could be around $55,000 to $157,000. The Suboxone lawyers also find a strong ground for the plaintiffs to bag punitive damages in the lawsuits.
Is Suboxone being taken off the market?
As per the U.S. Food and Drug Administration (FDA), the drug is not taken off the market for safety issues or effectiveness. There are still generic versions of sublingual buprenorphine available in the US, and Subutex is still available in some other countries. However, the company removed Subutex from the market in the United States in 2011, when the new drug was developed including naloxone.
How to reduce tooth decay while taking Suboxone? Few tips
After the Suboxone tablet dissolves inside the mouth, it is advisable to rinse your mouth with water. The individual can wait one hour after the medicine dissolves to brush teeth. This would help to prevent damage to the teeth and gums. While following the tips on a routine basis, the individual should get regular dental checkups throughout the medication period using Suboxone.
How does medical records of the plaintiffs change the destiny of Suboxone lawsuits?
Medical records can provide crucial evidence about the effectiveness of Suboxone in treating opioid addiction, or any harmful side effects experienced by the claimants. This information is vital in Suboxone lawsuits where the efficacy or safety of Suboxone is questioned.
Medical records review can reveal whether Suboxone was prescribed in accordance with accepted medical standards and guidelines. In cases where there is an allegation of inappropriate prescribing, medical records can be critical evidence. In cases alleging that Suboxone caused dependency or severe withdrawal symptoms, medical records serve as a primary source of evidence detailing the claimant’s experience with the drug. Medical record review reports can also act as a key evidence in verifying the claims made by plaintiffs in the lawsuit. They can provide a factual basis for understanding the claimant’s medical history and experiences with Suboxone.
The strength and clarity of medical records can significantly influence the outcomes of Suboxone lawsuits. Clear, detailed records supporting the claimant’s statements may lead to more favorable settlements or verdicts.
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