Zubsolv is a common medication used in the treatment of opioid dependence. Unfortunately, Zubsolv has recently been associated with severe oral complications like tooth decay and dental infections. If you are experiencing dental side effects after using the medication, you should talk to Consumer Alert Now. Our experts are accepting dental injury cases nationwide and will assist you in navigating the legal hurdles that come your way for maximum compensation for your Zubsolv injuries.
Zubsolv at a Glance
Zubsolv was produced and advertised by Orexo US, Inc. and received Food and Drug Administration (FDA) approval in 2013 as a treatment for opioid use disorder (OUD), or addiction, common among individuals with physical and psychological dependence on opioids. OUD is a major epidemic in the US and accounts for the majority of overdose deaths nationwide. When you develop an addiction to opioids, you cannot live without them because of their irresistible cravings. Thankfully, Zubsolv comes as sublingual tablets and contains two critical medicines, buprenorphine/naloxone, used to manage OUD.
The buprenorphine ingredient in the medication is a restricted opioid agonist that partially activates opioid receptors in drugs like heroin. The partial agonist property gives the drug a unique characteristic. Even if it activates the same receptors as opioids, it lowers the withdrawal effects and cravings by tricking your brain into believing it has access to the drug it craves. Also, it prevents the intense high linked to opioids.
The other ingredient, naloxone, contained in Zubsolv, is a full opioid antagonist that reverses opioid effects by kicking opioids off their receptors to give you instant sobriety. If you are on excessive prescriptions or are frequently relapsing on drugs like heroin, the naloxone ingredient in Zubsolv prevents the opioids you take from working.
FDA Warns of Dental Complications with Zubsolv
On January 12, 2022, the FDA warned the public of the severe dental injuries caused by buprenorphine, an active medicine in Zubsolv that is dissolved in the mouth. Dental injuries have been reported even in patients with no record of oral problems. Studies have linked the acidity of buprenorphine with severe dental issues like oral infections, tooth decay, tooth loss, and cavities. Besides, the FDA reports that most victims have severe tooth problems, with the typical treatment being tooth removal.
There is no denying that Zubsolv has been instrumental in fighting opioid addiction because it was one of the buprenorphine products approved by the FDA to treat the disorder. The attorneys in the Zubsolv suit are not asking for a medication ban. What they are asserting is that Orexo and other drug makers must sufficiently warn of the dangers of using the particular medications as prescribed so that buyers can make informed decisions and take the necessary measures to alleviate the risks.
The parties responsible for ensuring users’ safety failed to fulfill their mandate. They did not include sufficient warnings, instructions, or the risks posed by the medication. The manufacturer's lack of transparency and wrongful behavior jeopardized the lives of many users, denying them the chance to make a wise choice of treatment.
Zubsolv Side Effects
One of the buprenorphine products the FDA has approved for the treatment of opioid dependence is Zubsolv. The drug contains buprenorphine, whose partial agonists cause the salivary glands to reduce saliva production, which is crucial in maintaining good oral health. When this happens, you develop various dental complications, including decay. Possible dental complications associated with Zubsolv include the following:
- Oral infections.
- Tooth decay.
- Cracked teeth.
- Dental cavities.
- Tooth loss.
- Tooth extraction.
- Enamel and dentin loss.
- Dental crowns replacement.
You could be eligible for compensation through a Zubsolv lawsuit if you have sustained any of these injuries. At Consumer Alert Now, we believe that all parties who used the drug and suffered injuries can compel the manufacturer to pay a reasonable settlement for the damages.
Other Zubsolv Side Effects
Apart from the elevated risk of oral complications, Zubsolv has other severe complications, including:
- Breathing difficulties.
- Allergic reaction.
- Low blood pressure.
- Coordination difficulties.
- Liver complications.
- Physical dependence.
Zubsolv Tooth Decay: Scientific Studies
Studies conducted over ten years have backed up Zubsolv lawsuits today. These studies compelled the FDA to warn about Zubsolv usage risks or side effects.
One of these scientific studies is by The American Journal on Addictions and dates back to 2012: its focus was on a patient suffering from opioid dependence. Per the study, the patient being studied was using a product with a combination of buprenorphine and naloxone to treat OUD. The patient never adjusted their oral hygiene habits or increased their intake of sugary substances. This raised the alarm about the likelihood that frequent use of sublingual naloxone or buprenorphine could be the source of the dental issues.
Another study was published by the Primary Care Companion for CNS Disorders. Per the case series, eleven patients with OUD who developed dental complications after using buprenorphine were studied. The research shows that 54.5%, more than half of the users, experienced reduced salivary buffering potential. Saliva is critical to protecting the mouth against oral issues like tooth decay. Therefore, scientists linked dental complications with the reduced buffering capability. Additionally, the study identified the contact between the dissolving medicine and the teeth as the cause of tooth decay and cavities.
Also, The American Medical Association published a scientific study associating the drug with dental injuries. The study relied on a medical claims directory or database to review dental complication cases reported among patients using buprenorphine products like Zubsolv. The findings of the research show that there is an increased risk of oral complications among patients using these medications. Patients are required to administer the drug, holding it beneath the tongue for ten minutes. The extended contact between the buprenorphine and the teeth increases the risk of oral complications because of the low pH levels caused by the drug. Low saliva production destabilizes the mouth's pH, leading to severe dental complications.
The highly acidic conditions triggered by buprenorphine when exposed to the enamel or tooth surface cause demineralization, which is the dissolution of the enamel. Also, high acidity can be caused by acidic foods and beverages. Frequent use of these substances exposes the enamel to demineralization, eventually causing decay. Zubsolv manufacturers did not need these studies to know the drug's risks.
Despite the overwhelming proof linking dental complications with buprenorphine products and the fact that the ingredient is acidic, Orexo did not update its warning label. This simple action could have spared many users the dental injuries they suffer today. Warning of the risks would have prevented the lawsuits the company faces today.
Unfortunately, Orexo opted not to warn the public by ignoring decades of scientific studies associating severe dental complications with the high acidity of buprenorphine. They disregarded their primary duty, which is to address the risks the drug could have for users.
Many patients using Zubsolv are spending most of their time handling withdrawal symptoms and cravings. They give little or no focus to their oral hygiene, making them vulnerable. What remains is that people are managing OUD using Zubsolv, believing it is a safe and reliable way to fight opioid dependence. When users bought the drug, they believed it would help them overcome their addiction; if there were risks associated with using the drug appropriately, they should have been disclosed by the label or a medical professional. Unfortunately, those with this responsibility disregarded their legal duty, explaining the current lawsuits.
Zubsolv Lawsuit Claims
There are numerous plaintiffs nationwide bringing product liability claims related to Zubsolv. They claim that Orexo US, Inc. engaged in illegal and careless behavior by developing, designing, testing, packaging, advertising, labeling, distributing, and selling Zubsolv as safe.
The lawsuit claims Orexo knew or ought to have been aware that Zubsolv, when administered as instructed by a physician, had oral adverse events because of the too-high acidity linked to buprenorphine. Despite being familiar with the risks of the medication, the manufacturer promoted and sold it as safe. It was only in 2022 that the FDA came out to warn about the dangers of dental injuries associated with Zubsolv.
The FDA is not warning those already on the medicine to stop using it. No. If you are currently using Zubsolv, the agency recommends continuing the medicine unless your physician suggests otherwise. Sudden pauses in the medication can result in adverse withdrawal symptoms because your body is used to fighting these effects with buprenorphine. Also, a sudden stop of the drug can cause a relapse to opioid misuse, increasing the possibility of overdose or death.
Additionally, when using the oral dissolve form of Zubsolv, the FDA advises taking extra precautions to shield your teeth from the excessive acidity of buprenorphine after the powder has dissolved. The precaution involves taking a large sip of water and swishing it around the gingiva tissue and teeth before swallowing. Once you have swallowed the water, give yourself around sixty minutes for your mouth to return before you can brush. Brushing the teeth before they return to their normal pH can hurt your mouth, causing complications.
Similarly, when seeking treatment for OUD, you should inform your physician of your tooth history before they administer a buprenorphine product like Zubsolv. Besides, immediately after your doctor puts you on these drugs, you should visit your dental practitioner to inform them of the buprenorphine product you are using. The dentist will evaluate the condition of your mouth and perform the necessary treatment. If there is an existing condition that could have become severe because of buprenorphine, the dentist will address it. Furthermore, they will schedule regular appointments for thorough examinations during your use of Zubsolv. An experienced dentist will even arrange for a tooth decay prevention program. Do not hesitate to contact your dentist whenever you experience oral complications while on a buprenorphine product like Zubsolv.
The FDA also has some suggestions for healthcare experts after their warning. They recommend that medical experts like physicians acknowledge that the benefits of buprenorphine products like Zubsolv outweigh the dangers and are a reliable treatment for managing OUD. Blending the medicine with behavioral therapies like counseling can treat opioid dependence, sustain healing, and lower the chances of misuse or overdose.
Lastly, physicians must counsel patients about Zubsolv side effects, including tooth decay, and why it is crucial to take extra precautionary measures when using the drug, like seeing the dentist regularly and rinsing the soft tissue and teeth with a lot of water after the pill dissolves.
Zubsolv Class Action Suit
With the multiple Zubsolv lawsuits plaintiffs are filing at Consumer Alert Now, we are convinced that the cases will be combined to form a multi-district litigation (MDL) instead of a class action. An MDL is a process of consolidating multiple civil claims with a common question of fact and several plaintiffs with the same allegations against a typical defendant, like the Zubsolv suit.
If there are several federal court claims against the same defendant, a plaintiff or the accused can request an MDL from the judge. Doing so transfers the multiple cases in various federal courts to one district court. The federal court then addresses the discovery stage of the case and pretrial motions.
The difference between a class action and an MDL is that an MDL groups lawsuits from different courts and assigns them to one federal judge. Unlike a class action, where at least one plaintiff represents several individuals or groups, a class action involves several plaintiffs or groups.
Zubsolv Settlement Value
When plaintiffs sue a pharmaceutical company like Orexo, the amounts they will recover as compensation vary. The figure the jury will award or settle depends on the type and extent of the dental injury. Usually, injury claims like these help you obtain the following damages:
- Pain and anguish.
- Lost income, past, current, and future.
- Medical bills.
- Prescription medication.
Find a Zubsolv Lawsuit Near Me
When you have suffered adverse dental complications after Zubsolv use, it is time to look for professionals with the resources to help you receive compensation for the effects of a dangerous drug. Zubsolv lawsuit experts at Consumer Alert Now are eager to help you obtain justice. Therefore, if you have been diagnosed with tooth decay and other oral complications while using the medication, contact us at 800-511-0747 to arrange a meeting and discuss the merits of your claim.