Rabat – In February 2019, the French National Agency for the Safety of Medicines and Health Products (ANSM) decided not to recommend the use of Smecta for children under two, or to pregnant and breastfeeding women.
In recent weeks, the recommendation caused concern in Morocco. Medical professionals and users of the medicine alike, want clarification on whether the medicine is safe for adults, and whether it will remain on the market in Morocco.
According to ANSM’s website, this recommendation applies to all diosmectite medications used to treat diarrhea, gastric burns, or gastroesophageal reflux disease. The recommendation targets Smecta and its generics.
The cause of concern is the presence of lead in these clay-based medicines. Highly absorbent, clay obtained by soil extraction for medical purposes captures many impurities and small amounts of heavy metals, such as lead, naturally present in the environment.
Despite the cleaning process the clay undergoes to be transformed into drug, tiny quantities of the metal persist.
Following new international recommendations on drug-acceptable thresholds for heavy metals, the ANSM asked laboratories marketing clay-based medicines to ensure that there is no risk of lead passing through blood in treated patients, and especially in children.
In response, IPSEN Laboratories provided a clinical study on the subject. The results indicated that there is no risk of lead passing into the blood of adults treated with Smecta for 5 weeks.
However, ANSM states that this risk can not be ruled out for children under two. Therefore, it is recommended as a precaution not to administer Smecta or its generic Diosmectite Mylan to children under 2 years of age.
In 2018, Smecta ranked fifth in IPSEN ’s sales reaching €126 million in revenue, says Statista website.
The ANSM’s recommendation caused concern and confusion in Morocco.
Dr. Mohamed Lahbabi, president of the Confederation of Trade Unions of Pharmacists of Morocco (CSPM), explained to Moroccan channel 2M.ma that “the ANSM has only recommended to no longer prescribe Smecta to children under two.”
Lahbabi also criticized the “false information” relayed by certain Moroccan newspapers and news sites.
He further reprimanded “the amplification of the ANSM’s warning and of the information relating to the prohibition of sale and withdrawal of Smecta from Moroccan pharmacies.”
World Health Organization (WHO) defines lead as “a cumulative toxicant that affects multiple body systems and is particularly harmful to young children.”
WHO considers that “there is no known level of lead exposure that is considered safe.”