Health Canada warning on mycophenolate teratogenicity
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:
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze