Phthalates: 4 drugs under supervision

The National Agency for safety of the drug (ANSM) imposes precautions of employment for four drugs containing phthalates in quantities exceeding the thresholds recommended in Europe.

The European Agency of the drug (EMA) recently published draft recommendations to guide the use of phthalates as excipients in drugs. But in the meantime the replacement of phthalates in these pharmaceutical specialties, and as a precautionary measure, the National Agency for safety of the drug (ANSM) recommends that health professionals limit the dose and duration of treatment of the medicinal products concerned and to advise against use in children and pregnant or lactating.

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3 toxic phthalates to humans
Pushing its investigations, the ANSM has identified the presence of phthalates in about 150 drugs. “These compounds are particularly used for the coating of tablets and especially for tablets with active ingredient must be released gradually explains the ANSM.

Among these phthalates, three could be potentially toxic for humans: dibutyl phthalate (DBP), diethyl phthalate (DEP) and polyvinyl phthalate (PVAP) acetate.

But it is especially the DBP the ANSM has discovered, in quantities greater than those recommended by the European Medicines Agency in four drugs:

-The Acadione (suckable tablets): treatment of rheumatoid arthritis

-The Atrican (in the form of enteric soft capsule): an anti-parasitic that was in gynaecology. but that is off of marketing.

-The Prokinyl (in the form of capsules): a drug against nausea and vomiting.

-The Rowasa (tablets): treatment of ulcerative colitis.

The ANSM asked incumbent laboratories of authorizations for placing on the market of these 5 pharmaceutical specialties to reformulate them to provide, within a period of 18 months, lacking pharmaceutical forms of DBP.

In addition, records of these medicines are being modified to inform healthcare professionals and patients for the presence of phthalates among excipients. The ANSM also recommends that people who take one of these 4 medicines to take advice from their physician to limit their exposure to the potential effects of DBP.