Taking painkillers will cause ‘tooth fall’? 

The Global Drug Safety Alerts column is here to meet you again. At the beginning of 2022, there are 2 drugs with new drug warning information, let’s take a look at the detailed information!

FDA: Buprenorphine can cause serious oral problems, do not brush your teeth for 1 hour

■ Details :

The FDA warns that dental problems have been reported with the drug buprenorphine, which dissolves in the mouth.

These include the potential for severe caries, oral infections, and tooth loss, which have been reported even in patients with no dental history.

Despite these risks, buprenorphine is the primary treatment option for opioid use disorder (OUD) and pain, and the benefits of these drugs clearly outweigh the risks.

■ Drug Profile:

In 2002, the FDA approved buprenorphine as a sublingual tablet for the treatment of OUD. In 2015, buprenorphine was approved as a film to be placed in the cheek to treat pain.

There are also buprenorphine skin patches and injections approved for pain relief and OUD, but the FDA has not found these dosage forms to cause oral problems.

The benefits of buprenorphine still clearly outweigh the risks, especially in the treatment of OUD.

■ Information for medical staff:

1. Before prescribing a buprenorphine drug absorbed through the oral mucosa for treatment, ask the patient’s oral health history.

2. Serious oral problems have also been reported in patients with no previous oral medical history, so refer patients to a dentist as soon as possible after starting treatment.

3. Inform patients of possible dental problems and the importance of taking additional steps after the drug has completely dissolved, including gently rinsing teeth and gums with water, swallowing, and brushing again for at least 1 hour.

4. Dentists should conduct baseline oral assessments and caries risk assessments for patients taking medication, formulate dental caries prevention plans, and encourage regular oral examinations.

■ Information for patients:

1. Continue taking buprenorphine as prescribed; do not stop suddenly without first consulting a healthcare professional as serious consequences may occur:

• Stopping the drug suddenly can lead to withdrawal symptoms as the body becomes accustomed to the buprenorphine drug, or a repeat opioid overdose can lead to death.

• For those addicted to opioids, the benefits of buprenorphine use outweigh the risks and should be used in conjunction with other behavioral therapies in consultation with a professional.

• Comprehensive medication-assisted therapy (MAT) is one of the most effective ways to treat OUD and can help maintain recovery and prevent or reduce opioid overdose.

2. Patients using buprenorphine drugs that dissolve in the mouth should take additional steps to reduce the risk of potentially serious dental problems.

• After the medicine is completely dissolved, drink a large mouthful of water, rub it lightly over your teeth and gums, and swallow.

• You should wait at least 1 hour before brushing your teeth after taking the medicine to avoid damaging your teeth.

3. If there is a history of oral problems (including tooth decay) , please inform a medical professional:

• Schedule a dentist visit right after you start taking this medicine, tell the dentist that you are taking buprenorphine, and schedule regular oral exams while you are taking this medicine.

• Your dentist can customize a caries prevention plan for you.

• If you experience any problems with your teeth or gums, notify your healthcare professional and dentist right away.

MHRA: After 3 doses of bulocecizumab, the dosing interval should be ≥8 weeks

■ Details:

Maintenance doses of brolucizumab should be separated by no less than 8 weeks after the first 3 doses.

■ Drug Profile:

Brolucizumab is a human monoclonal antibody for the treatment of neovascular (wet) age-related macular degeneration (AMD) .

The recommended dose for the first 3 doses is 6 mg of Brolucizumab intravitreal injection every 4 weeks (monthly). Thereafter, maintenance intervals should be individualized based on disease activity.

Treatment every 12 weeks (3 months) should be considered for patients without disease activity and every 8 weeks (2 months) for patients with disease activity .

■ Information for medical staff:

1. Intraocular inflammation, including retinal vasculitis and retinal vascular occlusion, is a rare adverse reaction of intravitreal injection of Brolucizumab;

2. If the patient has intraocular inflammation or retinal vascular occlusion, the treatment with Brolucizumab should be stopped and treated in time;

3. In order to reduce the incidence of adverse reactions, do not use the maintenance dose of Brolucizumab after the first 3 doses with an interval of less than 8 weeks;

4. Closely monitor patients with a history of intraocular inflammation or retinal vascular occlusion who receive Brolucizumab (within 12 months prior to the first injection of Brolucizumab) , such patients are at increased risk of the above-mentioned adverse reactions after injection;

5. Intraocular inflammation or retinal vascular occlusion may occur during Brolucizumab treatment, but more frequently during early treatment;

6. Based on observational studies, brolucizumab treatment-induced retinal vasculitis and retinal vascular occlusion appear to be more common in female patients and patients of Japanese ancestry;

5. Please fill in any suspected adverse drug reactions related to Brolucizumab in the yellow card report.

■ Information for patients:

1. Seek immediate advice from your eye care team if you experience decreased or changed vision, eye pain, increased eye redness, or sensitivity to light following a Brolucizumab injection;

2. These may be symptoms of eye inflammation (including blocked blood vessels) and require prompt treatment;

3. If you are concerned about possible adverse reactions to the drug, be sure to read the treatment information provided and consult your doctor, nurse or pharmacist;

4. Do not discontinue Brolucizumab on your own without consulting an eye care provider, as discontinuation may increase the risk of blindness.