UPDATE: EMEA advises tougher labeling for Acomplia due to risk of psychiatric side effects
The European Medicines Agency (EMEA) says that French pharmaceutical group Sanofi-Aventis' anti-obesity drug Acomplia (rimonabant) should not be used by patients suffering major depression, or those who are receiving anti-depressant medication, due to the potential risk of psychiatric side effects. The news follows the firm's withdrawal of its US approval application earlier in the month (Marketletter July 9).
Public Citizen seeks EU Acomplia ban
Earlier this month, US consumers rights organization Public Citizen sent a letter to the EMEA urging the body to order the drug's withdrawal from the market. Sidney Wolf, director of Public Citizen's Health Research Group, suggested that the agency should take into consideration the non-approval recommendation given to the US Food and Drug Administration by its drug safety advisory committee prior to Sanofi's withdrawal of its NDA (Marketletter June 18).
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
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze