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FDA Drug Warnings - June 2022


buprenorphine

Transmucosal (buccal film or sublingual) 

NEW WARNING

The FDA has published a Drug Safety Communication warning that dental problems have occurred with use of buprenorphine products that are dissolved in the mouth. Tooth decay, cavities, oral infections, and loss of teeth have been reported, even in patients with no history of dental issues. The FDA is requiring a warning be added to buprenorphine prescribing information.

Prior to use of the transmucosal products, the health care provider should obtain an oral health history and refer patients to a dentist as soon as possible after starting the drug for a baseline dental evaluation, caries risk assessment, and caries preventative plan, and to encourage regular dental follow up.

Patients using the transmucosal formulations should be instructed to allow the drug to completely dissolve then gently rinse their teeth and gums with water and swallow the water. Patients should wait at least one hour before brushing their teeth.

Adverse effects from the use of transmucosal buprenorphine should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: June 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

Drug Warnings Archive


FDA Drug Warnings - February 2022
Janus kinase (JAK) inhibitorsVarious manufacturersNEW WARNINGThe FDA has issued a Drug Safety Communication to inform patients and health care providers that the Boxed Warning in the prescribing information for JAK inhibitors indicated for the treatment of arthritis and other inflammatory conditions is being revised.JAK inhibitors include baricitinib (Olumiant), tofacitinib (Xeljanz and Xeljanz XR), and upadacitinib (Rinvoq).The Boxed Warning information related to the risks of serious heart-related events, cancer, blood clots, and death must state that health care providers should consider the benefits and risk for each patient prior to starting or continuing therapy with baricitinib, tofacitinib, and upadacitinib. The risks of these events are increased in patients who are current or past smokers, those with other CV risk factors, those who develop a malignancy, and those with a known malignancy other than successfully treated nonmelanoma skin cancer. Because of these risks, use of these drugs should be reserved for patients who have had an inadequate response or intolerance to one or more tumor necrosis factor blocker.Patients should be advised of the benefits and risk of these drugs and to seek emergency medical attention if they experience signs and symptoms of a heart attack, stroke, or blood clot.Adverse effects from the use of JAK inhibitors should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: February 2022Nursing Drug Handbook© 2022 Wolters Kluwer