Product name:

Phenolphthalein

CAS number:

77-09-8

Synonyms:

3,3-bis-(p-hydroxyphenyl)phthalide; 3,3-bis(4-hydroxyphenyl)-1(3H)- isobenzofuranone; 3,3-bis(4-hydrophenyl)-phthalide

Country

Effective Date

Description of action taken
Grounds for decision

Canada

September 1997

After reviewing the benefits and risks associated with the use of phenolphthalein-containing laxatives Health Canada has concluded that there is a risk that phenolphthalein may cause cancer in humans, therefore the authority to sell and distribute these products has been revoked. (Press Release 1997-54, 30 September 1997.)

Morocco

November 1997

The Direction du médicament et de la pharmacie has suspended marketing authorization for phenolphthalein. (Reference: Letter from the Direction du médicament et de la pharmacie, Rabat, 8 September 2000.)

Oman

1998

The Directorate General of Pharmaceutical Affairs & Drug Control has prohibited the registration, import and sale of phenolphthalein in all laxative preparations, including candies or chewing gum, because of a potential risk of carcinogenicity. (Reference: Pharmaceutical Newsletter 5(4): 8 (1997), Ministry of Health, Muscat.)

Saudi Arabia

June 1999

The Ministry of Health has withdrawn from the market laxative products containing phenolphthalein because of a potential risk of carcinogenicity. (Reference: Communication from the WHO Regional Office for the Eastern Mediterranean enclosing a notification from the Ministry of Health, Saudi Arabia, 20 June 1999.)

Singapore

The National Pharmaceutical Administration in the Ministry of Health has rescheduled phenolphthalein to a Prescription- Only-Medicine due to its genotoxic and carcinogenic potential. (Reference: Communication to WHO, 2 August 2000.)