toxylact: a02bx04 vitamin u and lactation

The first professional lActological database in the word

ATC class A02BX04 comprises methylmethionine sulfonium chloride (commonly known as vitamin U), a gastric mucosal protector that is considered unsuitable for use during breastfeeding despite a low teratogenic risk in pregnancy.file+2

ATC class and pharmacology

  • ATC A02BX04 belongs to A02B “Drugs for peptic ulcer and gastro‑oesophageal reflux disease” and specifically to A02BX “Other drugs for peptic ulcer and GERD,” with A02BX04 representing methylmethionine sulfonium chloride (vitamin U) as a single‑substance antiulcer agent.wikipedia+1
  • Chemically, vitamin U is S‑methylmethionine sulfonium chloride (methylmethionine sulfonium chloride, MMSC), a methionine derivative found in many Brassica vegetables and teas, used historically in Japan and elsewhere as an oral gastric protectant.hamarichemicals+2
  • Its proposed mechanisms include support of gastric mucosal integrity and anti‑ulcer effects, as well as broader biological activities such as anti‑inflammatory and wound‑healing actions, although it is not recognized as a true vitamin in humans.healthline+2

Clinical use and kinetic profile

  • Vitamin U is marketed or used as an over‑the‑counter or supplementary treatment for gastric and duodenal ulcer disease, functional dyspepsia and non‑specific “gastric discomfort,” often in oral formulations.medicinenet+2
  • The locally described product information characterizes oral bioavailability as near‑complete, with onset of effect within about 60 minutes after ingestion and predominant renal elimination of unchanged compound within 24 hours of a single dose.file
  • It is not synthesized endogenously in the human body; nutritional exposure occurs mainly via cabbage, kale, turnip, celery, tomatoes and some green teas, where intake from foods is considered safe at customary dietary levels.healthline+1

Toxicological profile

  • Experimental and regulatory data indicate that methylmethionine sulfonium chloride can cause irritation of eyes, skin and the respiratory tract on direct contact, which aligns with clinical descriptions of organ‑targeted toxicity in susceptible individuals.file+1
  • The local toxicological review highlights potential for aseptic pulmonary inflammation, ocular irritation and allergic cutaneous reactions of immediate or delayed type, pointing to an idiosyncratic organ toxicity pattern rather than dose‑dependent systemic toxicity.file
  • From a reproductive‑toxicity perspective, vitamin U has been classified in the referenced monograph as FDA pregnancy category A, consistent with a low teratogenic risk signal in humans when used at therapeutic doses.file

Lactation risk assessment

  • According to the Bulgarian lactology monograph, methylmethionine sulfonium chloride is excreted into breast milk, which is pharmacokinetically plausible given its small molecular size, high oral bioavailability and low protein binding.pubchem.ncbi.nlm.nih+1
  • The same source emphasizes that, beyond transfer, the compound has a characteristic odor and taste that may “flavor” breast milk and lead to breastfeeding refusal by the infant because of an aversive change in milk taste.indiamart+1
  • When the possibility of organ‑targeted pulmonary or ocular toxicity in predisposed individuals is combined with the predicted milk transfer, the monograph classifies vitamin U as “Toxico‑lactation category IV – completely unsuitable for use during lactation,” recommending avoidance while breastfeeding.file

Practical recommendations

  • In pregnancy, use of A02BX04 may be acceptable when clearly indicated for treatment of ulcer disease or severe gastric symptoms, given the favorable teratogenicity profile, but should not be used as an unsupervised dietary supplement.medicinenet+1
  • During lactation, the balance of risk (possible infant organ toxicity and breastfeeding disruption) versus limited therapeutic necessity leads to a recommendation to avoid methylmethionine sulfonium chloride and to prefer alternative, well‑studied antiulcer agents with established lactation safety.infantrisk+1
  • If inadvertent short‑term exposure occurs in a breastfeeding mother, clinical monitoring of the infant for feeding difficulties, respiratory or ocular symptoms and skin reactions is reasonable, but ongoing treatment should be discontinued and an alternative selected.infantrisk+1

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