Belbuca is a medication specifically developed to alleviate pain caused by opioid withdrawal in individuals undergoing treatment for opioid addiction. However, recent medical studies have raised concerns about the potential severe side effects associated with the oral administration of medications like Belbuca. It has been found that long-term use of Belbuca, a long-acting opioid pain medication, may increase the risk of serious dental side effects, such as tooth decay.
If you or a loved one is suffering from tooth decay and you suspect that using Belbuca may have been the cause, you probably have numerous questions about your legal rights. At Consumer Alert Now, we have helped many individuals in similar situations in the past, providing them with a clear understanding of their legal options based on their specific circumstances.
What is Belbuca?
Belbuca, also known as buprenorphine, is classified as an opioid analgesic medication. It is specifically used to manage severe pain that necessitates continuous opioid treatment over an extended period. Typically, Belbuca is prescribed when other forms of pain relief, such as non-opioid medications or immediate-release opioids, have proven ineffective in providing satisfactory results.
Belbuca is available in several kinds, including two forms that dissolve in the patient’s mouth. These include:
- Films placed on the cheek can be used to manage pain.
- Tablets that are placed under a person’s tongue can be used for treating opioid use addiction.
Buprenorphine is available as a variety of opioid antagonists, including naloxone, for treating opioid addiction. These products come in two variations, which are consumed by dissolving the drug in the mouth. The following are the available forms:
- Films are placed either inside the cheeks or under the patient’s tongue.
- Tablets are administered under the tongue.
Buprenorphine is available in different forms, like transdermal patches (multiple generics and BUTRANS) and a long-acting injectable form (SUBLOCADE). Butrans and generic patches are applied on the skin to manage pain effectively. On the other hand, SUBLOCADE is specifically designed to treat moderate-to-serious opioid addiction in individuals who have previously received treatment using another Belbuca-containing product.
FDA Issues Warning About Belbuca's Link to Severe Dental Issues
In January 2022, the FDA issued a warning about dental issues that may occur as a result of using Belbuca, which contains buprenorphine as its active ingredient. These issues include dental caries (cavities), tooth loss, and oral infections. The FDA based its alert on a comprehensive review of serious event reports presented to its agency and medical literature published until December 2018. During the review, the FDA found 305 claims of oral adverse events linked to the use of Belbuca medications that were dissolved in the patient’s mouth. Out of these cases, 131 were classified as severe.
The agency found that individuals who suffer from opioid use addiction have a greater likelihood of experiencing poor oral health. Surprisingly, out of the 305 reports examined, 26 involved serious dental adverse cases in patients who had no previous dental issues. Additionally, most of these severe reports were linked to individuals using Belbuca for opioid addiction. However, 28 patients suffered severe oral issues while using Belbuca products approved solely for the management of pain or who had already reported using Belbuca for pain relief.
After reviewing 305 cases, the FDA found that dental problems were reported in patients on buprenorphine treatment. The average age group of patients was forty-two years, ranging from 18 to 71 years. In some cases, dental issues manifested as early as 2 weeks after starting the treatment, while the median period to diagnosis was approximately 2 years after starting treatment.
The FDA has received numerous reports from healthcare professionals documenting extensive patient dental issues. These issues include oral decay, tooth fractures, and tooth loss affecting multiple teeth. In some cases, eleven or more teeth have been affected. Out of 305 reported cases, 151 patients required treatment for dental adverse issues, with tooth removal or extraction necessary in 71 cases. Other treatments involved root canals, dental restoration, and surgery procedures, including implants and crowns.
It is important to note that the FDA didn’t raise any issues about oral adverse cases or any other kinds of Belbuca medication that are dispensed via skin patches or injections. However, this suggests that direct contact of the oral cavity with Belbuca can increase the risks of tooth damage and decay. The FDA has identified a risk related to buprenorphine and is mandating the acquisition of fresh alerts to the drug labeling and patient medication guidelines for all Belbuca-containing drugs that are dissolved.
The updated labeling would include suggestions for preserving or enhancing oral health while taking these drugs, such as recommending physicians refer individuals to oral care services and encouraging regular oral checkups during Belbuca treatment.
Belbuca Side Effects
The following are some of the side effects of using Belbuca medication:
- Cracked teeth.
- Tooth decay.
- Tooth loss.
- Crown replacement.
- Oral infection.
- Dental Caries (loss of enamel, dentine, and other tooth substances).
- Tooth extraction.
- Root canal.
- Opioid Addiction.
Opioid Use Disorder (OUD) is a devastating epidemic in the US, resulting in a staggering number of overdose deaths. Once individuals become addicted, they experience an overwhelming dependence on opioids, characterized by uncontrollable cravings and compulsive drug use. This urgent issue demands immediate attention and action to save lives.
Belbuca has been linked to serious tooth decay, which is believed to be caused by the acidity of buprenorphine products. Medical literature has documented cases of tooth decay related to orally administered medications containing buprenorphine since 2012. Moreover, the FDA has reported hundreds of adverse events annually linked to tooth decay. During this period, 40% of tooth decay cases were classified as severe.
On January 12, 2022, the FDA issued a warning regarding dental issues that have been reported concerning medication containing buprenorphine that is dissolved in a patient’s mouth. Some oral side effects may include any of the following:
- Tooth decay.
- Oral infections.
- Tooth loss.
Product Liability Lawsuit
Allegations have surfaced regarding the drug Belbuca, suggesting that it can potentially cause severe tooth injuries. Surprisingly, the medication did not include any warnings about cavities, tooth loss, oral infections, or tooth decay. These reported side effects have affected individuals who had no prior dental issues before taking the medication.
Accusations Against Belbuca
Belbuca lawsuit claims that prolonged use of the medication can potentially result in dental decay. The complaints suggest that taking Belbuca multiple times a day for an extended period may lead to tooth decay, and the patients weren’t adequately informed about this potential risk. If the plaintiffs had been properly informed about the possibility of Belbuca causing dental decay, they could have chosen a safer option and avoided its use altogether.
Other Effects of Using Belbuca Medication
While Belbuca is effective in treating certain conditions, it is important to note that it comes with its own set of potential side effects. One of these is an increased risk of tooth decay and other oral issues. Therefore, it is crucial to be fully aware of these potential risks before considering the use of Belbuca. These effects include the following:
- Opioid withdrawal signs include abdominal cramps, increased heart rate, and body aches.
- Redness in the mouth.
- Burning mouth syndrome.
- Back pain.
Recommendations By the FDA
The FDA recommends that individuals who have been issued Belbuca or any other buprenorphine medication should continue using them as directed in their prescription. It’s important not to abruptly stop taking the medication without consulting their physician. Doing so could result in serious health effects or even be life-threatening. Individuals should also receive teaching on ways to improve or maintain their dental health while having Belbuca as well as other similar medications.
After Belbuca has fully dissolved, it is recommended for the patient to take a gulp of water, gently swish it around the gums and teeth, swallow it, and then wait for at least an hour before brushing your teeth. This practice helps the mouth return to its normal state and reduces the danger of potential damage from brushing.
Additionally, the FDA advises patients to inform their healthcare providers about their history of dental issues, such as cavities, and promptly schedule a dental appointment after beginning treatment with Belbuca.
Belbuca Versus Suboxone
Belbuca and Suboxone are two distinct medications with notable differences. Suboxone is specifically designed to treat opioid addiction, while Belbuca is primarily used for pain management. Suboxone includes Naloxone as a deterrent against misuse, whereas Belbuca doesn’t. Furthermore, Belbuca contains lower buprenorphine doses compared to Suboxone.
Ways of Preventing Tooth Decay From Belbuca Use
The FDA advises these simple actions to help prevent tooth decay in individuals taking Belbuca:
- After allowing the buccal and sublingual formulation of Belbuca to dissolve, rinse your mouth with water.
- Schedule routine oral checkups.
- Wait at least one hour after taking Belbuca before brushing your teeth.
- Drinking water.
- Floss regularly.
Steps You Can Take
If you’re currently using a Belbuca product that dissolves in your mouth, it’s crucial to continue using it as directed, especially if you’re taking it for opioid addiction treatment. The advantages of using these Belbuca products for the cure of opioid addiction are greater than the associated risks, such as the possibility of oral adverse events.
It’s important never to stop using Belbuca products without consulting your physician first. Abruptly discontinuing their use could cause serious withdrawal signs or lead to a relapse of opioid abuse, which can lead to overdose and even loss of life. It is important to inform your healthcare provider about any history of dental problems, such as cavities, before using Belbuca.
You should plan for a dental checkup shortly after starting the prescription drugs and continue with regular oral checkups throughout treatment. In the event of any issues with your gums or teeth, it’s crucial to contact both your dentist and doctor without delay.
When using Belbuca medicine that is dissolved in the patient’s mouth, it’s crucial to follow these instructions:
- Once the dose is fully dissolved, take a generous sip of clean water.
- Swish the water gently around the gums and teeth, and then swallow.
It’s recommended to wait for at least 1 hour before cleaning your oral cavity to prevent any potential damage and allow the mouth to recover to its normal state.
If you’re experiencing any dental side effects due to the use of Belbuca medication that is dissolved in your mouth, it is crucial to discuss this with your physician. They will be able to guide you regarding whether you need to change to various forms of buprenorphine, like a shift to another medication, or a skin patch type, to treat your opioid addiction or pain. Additionally, you need to report the oral side effects to the FDA’s MedWatch online program.
Should I Inform My Dental Professional That I am Taking Belbuca?
It is crucial to consult with your doctor and follow the guidelines provided by the FDA before starting Belbuca treatment. If there is a history of dental problems, such as cavities, it is recommended to schedule a dental check-up promptly after beginning the medication. Informing your dentist about the drug will ensure comprehensive dental care. Your dental professional can create a personalized dental decay prevention schedule specifically tailored to your needs. If you experience any issues with your gums or teeth, it is crucial to promptly inform both your physician and dentist.
Do I Qualify to File a Belbuca Lawsuit?
If you have taken Belbuca and are facing dental issues, it is crucial to document your oral health before starting the treatment. This evidence will play a key role in the ongoing mass tort lawsuit that aims to address the cases of individuals who have experienced similar problems. Protect your rights by gathering the necessary documentation for your case.
Find a Belbuca Lawsuit Attorney Near Me
If you or someone you know has suffered tooth decay or other dental side effects after using Belbuca, you can contact Consumer Alert Now. You could be eligible for compensation by pursuing a Belbuca lawsuit, and we are here to assist you. We will assess your options and help you find the right lawyer to represent you, if necessary. Call us today at 800-511-0747.