16/01/02 – The AFSSAPS, France’s safety regulator for health products, has suspended the sale of products containing fluoride salts as a treatment for osteoporosis.
The agency said that its most recent assessment of the efficacy of sodium fluoride compared to its potential risks showed that it performed unfavourably compared to alternative treatments such as biphosphonates, especially given the potential long-term risks of fluorosis.
The AFSSAPS has therefore recalled from sale all speciality products containing fluoride salts: Architex from Cooper, Osteofluor 25mg pills from Lipha Sante and Fluocalcic from Yamanouchi Pharma.
The following is the notice of the ban that was placed on the French Government’s AFSSAPS website on January 15, 2002. An english translation of the notice is provided below.
AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE
15 janvier 2002
Suspension d’AMM et retrait de tous les lots des specialites contenant des SELS DE FLUOR
MED 02 / A 03 / B 01
MOTIF : Suite a la rvaluation par l’ Afssaps des traitements a base de sels de fluor dans l’indication du traitement curatif de l’osteoporose vertebrale avec tassement, le rapport efficacite/securite s’est revele defavorable notamment par rapport aux traitements alternatifs existants (biphosphonates…) et compte tenu du risque de fluorose along terme. L’Afssaps a donc suspendu les AMM des specialites contenant des SELS DE FLUOR dans cette indication. Tous les lots des specialites : ARCHITEX comprime effervescent (Cooper), OSTEOFLUOR 25mg comprime (Lipha Sante) et FLUOCALCIC comprime effervescent (Yamanouchi Pharma), sont retires du marche.
Rough english translation by Google:
Final withdrawal OSTEOFLUOR, FLUOCALCIC, ARCHITEX after the efficacite/security evaluation by AFSSAPS
Source: AFSSAPS January 15, 2002
REASON: Following the revaluation by Afssaps of the treatments containing fluorine salts in the indication of the curative treatment of the vertebral osteoporosis with compressing, the efficacite/security report/ratio appeared unfavourable in particular compared to the existing alternative treatments (biphosphonates…) and taking into account the risk of fluorose in the long run. Afssaps thus suspended the AMM of the specialities containing of FLUORINE SALTS in this indication. All batches of the specialities: Effervescent compressed ARCHITEX (Cooper), compressed OSTEOFLUOR 25mg (Lipha Health) and effervescent compressed FLUOCALCIC (Yamanouchi Pharma), are withdrawn from the market.
Note from FAN: The AMM is a marketing authorization/permit for the sale of a drug in France.