The US Food and Drug Administration has directed all manufacturers of drugs that are approved for attention-deficit hyperactivity disorder to alert users, via patient medication guides, of the possibility of cardiovascular risks and of adverse psychiatric symptoms. Drugmakers are also instructed to advise patients of precautions that can be taken.
Steven Galson, Director of the FDA's Center for Drug Evaluation and Research, warned that "medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well."
Dr Galson added: "in our commitment to strengthen drug safety, [the] FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new patient medication guides to better inform doctors and patients about these concerns."
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
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze