Health Canada warning on mycophenolate teratogenicity

19 January 2016

A cumulative review of birth defects has confirmed that mycophenolate is a human teratogen, says pharmaceutical regulator Health Canada. The evidence showed an increased rate of congenital malformations and spontaneous abortions associated with mycophenolate in comparison with other immunosuppressants.

The products affected are: CellCept (mycophenolate mofetil) – all dosage forms (capsules, tablets, oral suspension, injection). The brand is marketed by Swiss pharma major Roche (ROG: SIX); Myfortic (mycophenolic acid [as mycophenolate sodium]) – tablets, from Switzerland-based Novartis (NOVN: VX); and all generic versions of mycophenolate-containing products.

New contraindications will be added to the CellCept and Myfortic Canadian Product Monographs to strengthen safety information for use:

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