The National Medicines Safety Agency (ANSM) has just sent a letter to health professionals asking them to no longer prescribe Proctolog, whether in the form of rectal cream or suppositories, to their patients who suffer from hemorrhoids or anal fissure.
ANSM “considers that the benefit / risk ratio of suppositories and rectal cream combining trimebutine with ruscogenins is negative, in the light of updated efficacy and safety data” explains the agency in its letter, also sent to pharmacists.
The withdrawal of the marketing authorization (AMM) will be effective on July 6. The batches of this drug marketed by the Pfizer laboratory will therefore be withdrawn from pharmacies tomorrow.
Too many allergic risks
The drug Proctolog was put on the market in the 1970s for the treatment of symptoms of “painful and itchy anal manifestations”, that is to say for relieve hemorrhoidal crises and fissure syndromes. As this drug combines two molecules (trimebutine and ruscogenins), the ANSM has re-evaluated the efficacy and safety data, as it does for many drugs marketed before 2005.
With regard to immuno-allergic risks, “contact dermatitis, urticaria, eczema, edematous reaction or even anaphylactic shock“, the benefit-risk ratio of the drug was considered negative.
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