Italian OTC Makers Defend Phenophthalein

The Italian over-the-counter drug manufacturers' association,Assosalute, has defended nonprescription drug products used as laxatives which contain phenolphthalein, currently under attack by the US Food and Drug Administration (Marketletters passim).

Products of this type are made by a number of companies in Italy, with annual sales of about 50 billion lire ($29 million).

The Italian consumers' association, Aduc, attacked the products following the FDA review, and a note in response has been sent by Assosalute to all the self-medication manufacturers belonging to the Federchimica association. Assosalute says there is no epidemiological evidence establishing a link between phenolphthalein and the risk of tumors. Aduc points out that the FDA is proposing a ban on these drugs, and notes that the European Medicines Evaluation Agency has recommended that European Union countries adopt modified or restricted use of drugs containing this substance.