english.prescrire.org > Spotlight > Archives : 2017 > Drug regulatory agency moves to suspend sales of French vitamin D supplement Uvestérol°, following the death of an infant

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Drug regulatory agency moves to suspend sales of French vitamin D supplement Uvestérol°, following the death of an infant

Prescrire welcomes the move by France's health products agency (ANSM) to suspend sales of the French vitamin D supplement Uvestérol° D. This decision should have been made years ago, especially as there are other forms of vitamin D that are less complicated to administer and less risky.

After the French press reported the death of a newborn who had received a dose of
Uvestérol° D, the French health products agency announced on 4 January that it is taking measures to suspend sales of the drug.

Prescrire welcomes the ANSM's move to suspend sales of Uvestérol° D. This decision should have been made years ago, especially since there are many other forms of vitamin D that are less complicated to administer and less risky. Years that have been wasted for the infants who have suffered fainting spells, sometimes serious or even fatal. Years that have been wasted by the drug company, which would have had ample time to develop forms of Uvestérol° D and Uvestérol° ADEC that were simpler to administer (without the pipette) and less risky.

Prescrire applauds the person who made the connection between this death and Uvestérol° D, and who passed along the information.

Vitamin D supplements are given to infants to prevent vitamin D deficiency.

Fainting spells, sometimes serious ones, caused by Uvestérol° (D or A, D, E, C) have been reported since 1996. The drug is administered to infants orally, using a pipette.

Over the years, various changes have been made to Uvestérol° and its pipette. But there is no tangible evidence indicating that these changes have reduced the fainting risk. No fainting has been reported with other pharmaceutical forms of vitamin D (Zyma D° or other brands).

Prescrire's French edition has published numerous articles about fainting tied to Uvestérol°.

In particular, this review published in June 2015:

  • Uvestérol° : nouvelles formulations, mais pas d’évaluation du risque de malaise
    (Uvestérol°: new forms, but no evaluation of the fainting risk)
    Rev Prescrire 2015 ; 35 (380) : 420.
    > Pdf (In French, free)

as well as:

  • En finir avec Uvestérol° pour éviter les malaises chez les nouveau-nés (5/2014)
    (Get rid of Uvestérol° to avoid fainting spells in newborns)
    > Free (In French)

  • Apport de vitamine D aux nourrissons : pas d'Uvestérol° ! (5/2011)
    (Vitamin D supplementation in infants: do not use Uvestérol!)
    > Free (In French)

©Prescrire 4 January 2017
For more information:

Uvestérol° : nouvelles
formulations, mais
pas d’évaluation
du risque de malaise
Rev Prescrire 2015 ;
35 (380) : 420.
Pdf, free (In French)

En finir avec Uvestérol°
pour éviter les malaises
chez les nouveau-nés
(May 2014)
Free (In French)

Apport de vitamine D
aux nourrissons :
pas d'Uvestérol° !
(May 2011)
Free (In French)

See also:

Preventing rickets
with vitamin D.
Supplementation
for some children
Prescrire Int 2014:
23 (147): 73-78
Pdf, subscribers only