Spanish
Santo Domingo.- The General Directorate of Medicines, Food and Sanitary Products (DIGEMAPS) informs the population about the safety alert for adverse reactions in the use of Colgate Total 50g Active Prevention Clean Mint stannous fluoride toothpaste.
The DIGEMAPS decision comes as a result of GGMON Alert No. 03/2025 issued by the National Health Surveillance Agency (ANVISA) of Brazil, within the framework of its cosmetovigilance activities related to adverse reactions to the use of toothpaste with stannous fluoride.
DIGEMAPS specified that the company Colgate-Palmolive confirmed that to date it has only received six consumer complaints in the country that include non-serious adverse events, after having sold 2 million 581 thousand 260 units of Colgate Clean Mint toothpaste, considering that the facts reflected in the Dominican Republic differ from the cases reflected in Brazil.
Consumer reports in Brazil indicate possible adverse reactions related to the use of toothpaste containing stannous fluoride, including oral lesions such as ulcers, sores, and blisters, painful sensations such as pain, burning, and stinging, inflammation in the tonsils, lips, and oral mucosa. Also, numbness in the lips and mouth, gum irritation, and other symptoms including problems with the tongue.
What is Stannous Fluoride?
Tin Fluoride is an antimicrobial agent that has several clinical effects, stops cavities in the mineral phase of the teeth, reduces the viability of the oral biofilm known as dental plaque, decreases dental hypersensitivity, and improves gingival health. Typically, Tin Fluoride was found to be the most effective additive against four conditions.
What does Colgate Palmolive say?
Colgate-Palmolive assured that they will continue to carefully monitor the comments of consumers, professionals, and other stakeholders to take any preventive action that may be necessary.
It also states that the rest of the presentations marketed in the Dominican Republic are of Mexican manufacture and their Sanitary Registry corresponds to PC2024-0236.
DIGEMAPS urges the general population to send any information, notification of suspected adverse reactions so that the appropriate measures can be taken to the telephones 809-541-3121 ext. 6681 and 6682, also to the email farmacoviligancia@digemaps.gob.do.
