Marketed in the form of a rectal cream or suppositories, the Proctolog hemorrhoid drug is withdrawn from the market as of July 6th.
The National Agency for Drug Safety (ANSM) has just sent a letter to health professionals asking them to no longer prescribe Proctolog, either 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 associating trimebutine with ruscogenins is negative, given the updated efficacy and safety data," explains the agency in its mail, also sent to pharmacists.
The withdrawal of the Marketing Authorization (MA) will take effect on 6 July. The batches of this drug marketed by the Pfizer laboratory will therefore be removed from pharmacies tomorrow.
TOO MANY RISKS
The drug Proctolog was put on the market in the 70's for the treatment of the symptoms of "anal painful and itchy manifestations", that is to say relieve hemorrhoids
and fissure syndromes. This drug combining two molecules (trimebutine and ruscogenins), the ANSM conducted a reassessment of efficacy and safety data, as it does for many drugs on the market before 2005.
In view of the immuno-allergic risks, "contact dermatitis, urticaria, eczema, edematous reaction or even anaphylactic shock", the benefit-risk ratio of the drug was considered negative.
