FDA Warns About Dental Problems With Buprenorphine Medicines

One drug commonly used nationwide to manage opioid use disorders (OUD) is buprenorphine, but despite this, the drug causes adverse dental events. The Food and Drug Administration (FDA) warns the public about the safety of drugs containing buprenorphine. The oral problems caused by the drug include tooth decay, dental cavities, dental infections, and tooth loss, even in users with no record of oral issues. If you have been using the drug before the warning and have noticed these problems, you should speak to a legal expert to know if you have a claim against the maker of the drug.

Buprenorphine Background

Buprenorphine is a drug that treats opioid dependence. The FDA originally approved the drug in 2002 for use as a prescription in the treatment of OUD. The first approval was for buprenorphine tablets administered by dissolving them below the tongue. In 2015, the FDA approved the film version of buprenorphine administered by attaching it to the cheek.

Buprenorphine is a partial or restricted opioid agonist. Taking the medication causes a high effect, although it is not a full agonist like heroin. The medicine helps lower opioid addiction symptoms like withdrawal effects or cravings. Besides, it promotes safety if you overdose and lowers the possibility of misuse.

However, the drug has side effects because it lowers saliva production by the salivary glands, causing dry mouth. Saliva is critical to maintaining healthy teeth. Therefore, you risk tooth decay and other dental problems during low production.

Despite the existence of these risks, the drug is critical in the management of OUD and pain. The advantages of the medication outweigh the downsides.

Action the FDA is Taking

The FDA is urging the inclusion of a warning about drug risks on the labels and medication guides of all medications with buprenorphine as an active ingredient, rather than a prohibition on the medications themselves. Administering and patient details should include information on maintaining healthy teeth or enhancing your dental health using buprenorphine. The agency requests physicians prescribing the medication to patients with oral issues to send them to dental care facilities for treatment and encourage those using the drug to maintain regular visits to dentists. Also, during dental visits, patients should not forget to mention their medication, mainly if it contains buprenorphine.

Recommendations by the FDA for Patients and Caregivers

Individuals taking buprenorphine are required to keep taking the medication as prescribed by their doctor. Stopping to take the medication after the safety warning without consulting with your doctor can cause severe side effects, like withdrawal symptoms. Your body was already used to the buprenorphine ingredients in the medicine you were taking, and a sudden stoppage could lead to a reversion to opioid abuse, overdose, and death. Even after learning of the drug’s safety risks, the benefits of the medication outweigh the risks; hence, it should not be a reason for you to suspend its use. Instead, it would help if you combined the treatment with counseling. Complementing the medications with therapy has proven to be effective in treating OUD and preventing overdose and abuse.

If you take the medicine by dissolving it under the tongue, the FDA recommends taking particular steps to lower the risk of dental harm. When the drug dissolves completely, sip a lot of water and gently swish around the teeth and the gum tissue, then swallow. After, wait for 60 minutes before you can brush to avoid damaging the teeth and gums. Waiting for this duration allows the mouth to return to its natural pH levels.

When visiting your dental healthcare provider, discuss your dental health history. Mention the tooth problems you have had, like oral infections and cavities. Besides, when your physician puts you on buprenorphine, you should schedule an appointment with your dentist not long after to check the condition of your teeth and gums. After the meeting, you should make regular visits for dental exams. The appointments aim to identify tooth decay and other dental issues as they occur and provide customized treatment to arrest the condition before it becomes severe or prevent it. Any time you observe signs of tooth decay or cavities, do not hesitate to contact your dentist to take action.

Recommendations for Medical Professionals

Despite the FDA warning, medical professionals like doctors and physicians should know that buprenorphine benefits outweigh the downsides and, therefore, should not suspend their prescription. Instead, as a healthcare professional, you should combine therapy and drugs for effective OUD management.

It would be best if you also inquired about the dental health history of your patients before administering a medicine that contains buprenorphine as an active ingredient. This is despite patients who have no record of dental problems reporting tooth decay and infections after using buprenorphine. Whenever you put your opioid disorder patient on buprenorphine, you should send them to dental professionals for evaluation, monitoring, and treatment of oral conditions.

Similarly, you must counsel your patients on the possible oral problems they are likely to face when they start treatment. Also, doctors should educate patients on steps to take after taking the medicine to minimize the harm it causes to their tooth enamel and gums. Some steps patients can take to protect their teeth include rinsing the mouth with water, swishing, and gulping. Besides, the patient should not brush their teeth immediately after taking medication. Instead, they should wait for sixty minutes before brushing. Doctors should also thoroughly evaluate the condition of the patient’s teeth for risk analysis and encourage frequent checkups.

Reporting Buprenorphine Side Effects

The FDA urges doctors and their patients to report any adverse side effects, like tooth decay, to their MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting online forms.

The Risks

All medications have side effects, even with proper prescriptions and use. However, the advantages of using medicine outweigh the disadvantages. Patients respond to medications differently depending on genetic factors, their health history, and other drugs they could be using. Therefore, it is unlikely for the FDA to determine which patients will have adverse events after taking buprenorphine and which will not. Thus, the focus should be on combining the treatment with therapy and not stopping usage.

Find Assistance With a Buprenorphine Claim Near Me

Even though the FDA encourages people to continue taking buprenorphine for OUD, if you or your patients have developed adverse events like tooth decay, you should talk to Consumer Alert Now. We will explain why you are experiencing dental problems and the legal action to take to receive compensation for the injuries. Call us today at 800-511-0747 to discuss your case.