Last update: Dec. 4, 2020

Phenolphthalein

Very High Risk for breastfeeding


Very unsafe. Contraindicated.
Use of an alternative or cessation of breastfeeding.

Derived from phenol with laxative properties due to direct irritation through contact with the intestinal mucosa.

Since the last update, we have not found published data on its excretion in breastmilk.

Although intestinal absorption is only 15% (PubChem 2017), it may transfer into breastmilk and could cause diarrhoea and other intestinal problems in the infant (PubChem 2017).
Carcinogenic in animals and probable carcinogenic (2B) in humans (WHO 2000, EMA 1997).

It has been withdrawn from sale in most countries.

Bulking, osmotic, emollient, or lubricating laxatives are safer.

In order to avoid or treat constipation, a balanced diet, rich in fibre, is essential,
with plenty of fluids and exercise.

RISK LEVEL OF WORKPLACE EXPOSURE
According to international regulations (INSHT 2017 and 2008, EC Regulation 2008), all potentially polluting or health-damaging products must be labelled with a safety data sheet containing the so-called risk phrases (formerly known as R phrases, currently H phrases for hazard) or prudence (P phrases).
There are two phrases that are specifically related to breastfeeding:
- H362 (formerly R64): "It can harm children fed with breastmilk"
- P263: "Avoid contact during pregnancy and breastfeeding”.

Five other phrases that should be considered during breastfeeding are related to the carcinogenic, mutagenic or cumulative effects of a product:
- H350 (formerly R45 and R49): "May cause cancer"
- H351 (formerly R40): "Possible carcinogenic effects"
- H370 (ant. R39): "Causes damage to organs”
- H371 (ant. R68): "May cause damage to organs”
- H372 (ant R48): "Causes damage to organs through prolonged or repeated exposure”
- H373 (ant. R33): "May cause damage to organs through prolonged or repeated exposure.

If any of these five phrases appears in the safety data sheet of an industrial product, the breastfeeding mother must be removed from her workplace. Phenolphthalein has phrase H350 (Merck 2018).

In addition, according to current European legislation (EC Regulation 2008), when a product is carcinogenic and mutagenic, breastfeeding working mothers should not be exposed to mixtures, be they of solids, liquids or gases, with concentration limits higher than 0.3%.

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Phenolphthalein in other languages or writings:

Groups

Phenolphthalein belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Phenolphthalein in its composition:

  • Alin
  • Anson™. Contains other elements than Phenolphthalein in its composition
  • Beagarol™. Contains other elements than Phenolphthalein in its composition
  • Coslax™. Contains other elements than Phenolphthalein in its composition
  • Doce Alivio™. Contains other elements than Phenolphthalein in its composition
  • Emulax™. Contains other elements than Phenolphthalein in its composition
  • Fenokomp 39™. Contains other elements than Phenolphthalein in its composition
  • Fructines (Argentina)
  • Genolaxante™. Contains other elements than Phenolphthalein in its composition
  • Heroanson™. Contains other elements than Phenolphthalein in its composition
  • Jaglax
  • Laksafenol
  • Laxadine™. Contains other elements than Phenolphthalein in its composition
  • Oblax A-1-1™. Contains other elements than Phenolphthalein in its composition
  • Paralax™. Contains other elements than Phenolphthalein in its composition
  • Taeniacide™. Contains other elements than Phenolphthalein in its composition
  • Zenda™. Contains other elements than Phenolphthalein in its composition

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 15 %
Molecular weight 318 daltons

References

  1. INSHT - Instituto Nacional de Seguridad e Higiene en el Trabajo. Límites de exposición profesional para agentes químicos en España. 2017 Full text (in our servers)
  2. PubChem. Phenolphthalein. Compound Summary. 2017 Full text (link to original source) Full text (in our servers)
  3. INSHT. Listado de compuestos Cancerígenos y Mutágenos categorias 1A y 1B. 2012 Full text (in our servers)
  4. INSHT. Regulación UE sobre productos químicos (II). Reglamento CLP: aspectos básicos. 2008 Full text (in our servers)
  5. REGLAMENTO (CE) No 1272/2008 DEL PARLAMENTO EUROPEO Y DEL CONSEJO de 16 de diciembre de 2008 sobre clasificación, etiquetado y envasado de sustancias y mezclas. Diario oficial de la Unión Europea. 2008 Full text (in our servers)
  6. WHO. International Agency for research on Cancer. PHENOLPHTHALEIN. IARC monographs on the evaluation of carcinogenic risks to humans. Vol.76-15. 2000 Full text (link to original source) Full text (in our servers)
  7. WHO. International Agency for research on Cancer. PHENOLPHTHALEIN. Summary of final evaluations. IARC monographs on the evaluation of carcinogenic risks to humans. Vol.76-17. 2000 Full text (link to original source) Full text (in our servers)
  8. EMA. Genotoxic and carcinogenic potential of phenolphthalein Position Paper 1997 Full text (link to original source) Full text (in our servers)

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