Breaking News
August 16, 2018 - Seven activities that prevent you from getting quality sleep during summer
August 16, 2018 - Five ways to tell if your baby is getting enough milk from breastfeeding
August 16, 2018 - From Pigs to Peacocks, What’s Up With Those ‘Emotional-Support Animals’?
August 16, 2018 - Breast cancers enlist the help of normal cells to help them spread and survive
August 16, 2018 - Engaging with “high-need” patients outside the clinic
August 16, 2018 - Research illuminates how online forum may offer suicide prevention support for males
August 16, 2018 - Researchers identify way to grow immune cells at large scale for preventing cancer reoccurrence
August 15, 2018 - Keck Medicine of USC’s hospitals ranked among nation’s best for the 10th consecutive year
August 15, 2018 - Researchers compare existing approaches for automating diagnostic procedures of skin lesions
August 15, 2018 - Autism risk determined by health of mom’s gut, research reveals
August 15, 2018 - WELL for Life challenges you to explore the great outdoors
August 15, 2018 - ‘Zombie’ gene protects elephants from cancer, study finds
August 15, 2018 - Ebola outbreak in Congo spreads to active combat zone
August 15, 2018 - Study highlights pollution exposure of babies in prams
August 15, 2018 - Study provides insight into link between sleep apnea and lipid metabolism
August 15, 2018 - New study focuses on promise of gene therapy for Amish nemaline myopathy
August 15, 2018 - Researchers discover new approach to alleviate chronic itch
August 15, 2018 - Uncovering the Mysteries of MS: Medical Imaging Helps NIH Researchers Understand the Tricky Disease
August 15, 2018 - Autistic people at greater risk of becoming homeless – new research
August 15, 2018 - New imaging technique can spot tuberculosis infection in an hour
August 15, 2018 - Scientists study effects of eating breakfast versus fasting overnight before exercise
August 15, 2018 - Talking with children about suicide could save lives
August 15, 2018 - Grip strength of children predicts future cardiometabolic health
August 15, 2018 - Innovative oncofertility program launched by RMA of New York and Mount Sinai Health System
August 15, 2018 - Simple score helps predict which hospitalized heart attack patients are at high risk of readmissions
August 15, 2018 - New discoveries show how protein droplets do more than keep cells’ interiors tidy
August 15, 2018 - Study shows impact of optimizing airport flight patterns on human health
August 15, 2018 - Life experiences of feeling unwanted or unplanned associated with attachment insecurity
August 15, 2018 - ACS Briefing Discusses Use of Lessons From Combat Care
August 15, 2018 - Study identifies distinct origin of ADHD in children with history of brain injury
August 15, 2018 - IgG3 antibody stops B cells from fighting pathogens in HIV patients
August 15, 2018 - Scientists discover key vulnerability of mixed lineage leukemia
August 15, 2018 - College students may experience pressures from secondary exposure to opioid abuse
August 15, 2018 - Powerful new microscope reveals inner workings of human cells with unprecedented clarity
August 15, 2018 - Married people who fight nastily more likely to suffer from leaky guts, study suggests
August 15, 2018 - Working Out After Baby – Drugs.com MedNews
August 15, 2018 - Rheumatoid Factor (RF) Test: MedlinePlus Lab Test Information
August 15, 2018 - ADHD linked to an increased risk of injury in children, study finds
August 15, 2018 - UIC researchers receive NIH funding to develop a better way to regenerate bone or tissues
August 15, 2018 - Study reveals how immune cells in the brain influence sexual behavior
August 15, 2018 - Researchers move closer to finding potential soft spot in drug-resistant tuberculosis
August 15, 2018 - Real-time dynamic monitoring of cell’s nucleus for effective cancer screening
August 15, 2018 - Lower rates of Medicare preventive care visits found in racial, ethnic minority older adults
August 15, 2018 - Scientists identify stress hormone as key factor in failure of immune system to inhibit leukemia
August 15, 2018 - Cytoplan introduces three new nutritional supplements
August 15, 2018 - Effective hemorrhage control critical for survival after motorsport accidents
August 15, 2018 - Sygnature Discovery announces ambitious expansion plan with addition of Alderley Park facility
August 15, 2018 - Dietary carbohydrates could lead to osteoarthritis, new study finds
August 15, 2018 - Male tobacco smokers have decreased number of cannabinoid CB1 receptors, study reveals
August 15, 2018 - Scientists explore ways for drug therapies to reach deadly brain tumors
August 15, 2018 - Rethinking fundamental rule of stroke care: ‘Time is brain!’
August 15, 2018 - Scientists reveal role of ‘junk DNA’ in cancer dissemination
August 15, 2018 - Google’s DeepMind AI could soon be diagnosing eye conditions
August 15, 2018 - Scientists trick the brain to embody the prosthetic limb
August 15, 2018 - Researchers focus on uncoupling obesity from diabetes
August 15, 2018 - Clinical study shows how EarlySense system effectively detects opioid-induced respiratory depression
August 15, 2018 - A class of proteins shown to be effective in reducing drug-seeking behaviors
August 15, 2018 - FundamentalVR launches first-of-its-kind SaaS software platform for surgical simulation
August 15, 2018 - Gemphire Announces Termination of Phase 2a Clinical Trial of Gemcabene in Pediatric NAFLD
August 15, 2018 - Rheumatoid arthritis in pregnancy associated with low birth weight and premature birth
August 15, 2018 - Study may help increase effectiveness of antibiotics against drug-resistant bacteria
August 15, 2018 - Analyzing resident-to-resident incidents in dementia may hold the key to reducing future fatalities
August 15, 2018 - Robotic walking frame aims to help maintain mobility of older adults
August 15, 2018 - Simple intervention during routine care reduces alcohol consumption in men with HIV
August 15, 2018 - Genetics Home Reference: gout
August 15, 2018 - Scientists ID genesis of disease, focus efforts on shape-shifting tau
August 15, 2018 - OncoThira and NDSU enter into license agreement to develop, market cancer compounds
August 15, 2018 - Scientists unravel the mystery behind ovarian cancer with high-grade serous carcinoma
August 15, 2018 - Common signs that indicate vision problems in children
August 15, 2018 - Removing the cancer label – overhaul in cancer classification proposed
August 15, 2018 - Prams may expose babies and toddlers to more air pollution finds study
August 15, 2018 - Duke researchers track missing T-cells in glioblastoma patients
August 15, 2018 - Cardiac Profiles Up With Exercise, Less Sitting in Early Old Age
August 15, 2018 - Precision medicine offers a glimmer of hope for Alzheimer’s disease
August 15, 2018 - Immunovia’s new blood-based testing platform accurately detects non-small cell lung cancer
August 15, 2018 - New method provides a ‘big picture’ of genetic influences on traits and diseases
August 15, 2018 - Early Onset Type 1 Diabetes Linked to Heart Disease, Shorter Life
August 14, 2018 - SMURF1 provides targeted approach to preventing cocaine addiction relapse
August 14, 2018 - Genetic testing pushed for hereditary high cholesterol disease
August 14, 2018 - Researchers discover new genes involved in Alzheimer’s Disease
FDA Alert: Oral Over-the-Counter Benzocaine Products: Drug Safety Communication

FDA Alert: Oral Over-the-Counter Benzocaine Products: Drug Safety Communication

image_pdfDownload PDFimage_print

May 23, 2018

Audience: Pediatrics, Dentistry, Consumer, Health Professional, Pharmacy

ISSUE: The FDA is warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label. These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine, a local anesthetic, can cause a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, can be life-threatening and result in death. Due to the significant safety risk of methemoglobinemia, we have urged manufacturers that they should stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years. If companies do not comply, we will take action to remove these products from the market.

We have also urged manufacturers of OTC oral drug products containing benzocaine for adults and children 2 years and older to make the following changes to the labels of their products:

  • Adding a warning about methemoglobinemia;

  • Adding contraindications, FDA’s strongest warnings, directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years; and

  • Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.

BACKGROUND: Benzocaine is a local anesthetic contained in some OTC products for the temporary relief of pain due to minor irritation, soreness, or injury of the mouth and throat. Benzocaine products are marketed as gels, sprays, ointments, solutions, and lozenges under brand names such as Anbesol, Orabase, Orajel, Baby Orajel, Hurricaine, and Topex, as well as store brands and generics. Prescription local anesthetics include articaine, bupivacaine, chloroprocaine, lidocaine, mepivacaine, prilocaine, ropivacaine, and tetracaine.

RECOMMENDATION:
We continue to monitor the safety and effectiveness of OTC benzocaine products and intend to take additional actions in the future as needed. We will notify the public about any updates. In addition to our recent actions regarding OTC benzocaine products, we are also requiring a standardized methemoglobinemia warning to be included in the prescribing information of all prescription local anesthetics.

Parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething.  

Topical pain relievers and medications that are rubbed on the gums are not useful because they wash out of a baby’s mouth within minutes. FDA has previously cautioned parents and caregivers to not give certain homeopathic teething tablets to children. Alternative treatments for adults who experience mouth pain may include dilute salt water mouth rinse and OTC pain relief medications. Adults should follow the American Dental Association’s recommendations for mouth sores:

  • Schedule regular oral health checkups

  • Keep a diary of what you eat and drink

  • Keep a list of oral hygiene products you have been using

  • Avoid all tobacco products

  • If you drink alcoholic beverages, do so in moderation

  • See your dentist if you notice any change in your mouth.

Consumers using benzocaine products to treat mouth pain should seek medical attention immediately for signs and symptoms of methemoglobinemia. These include pale, gray or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and fast heart rate. Signs and symptoms of methemoglobinemia may appear within minutes to one to two hours after using benzocaine. Symptoms may occur after using benzocaine for the first time, as well as after prior uses.

Health care professionals should warn patients of the possibility of methemoglobinemia and advise them of the signs and symptoms when recommending or prescribing local anesthetic products. Some patients are at greater risk for complications related to methemoglobinemia. This includes those with breathing problems such as asthma, bronchitis, or emphysema; heart disease, and the elderly. Health care professionals using local anesthetics during medical procedures should take steps to minimize the risk for methemoglobinemia. These include monitoring patients for signs and symptoms suggestive of methemoglobinemia; using co-oximetry when possible; and having resuscitation equipment and medications readily available, including methylene blue.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/23/2018 – Drug Safety Communication – FDA]

Tagged with:

About author

Related Articles