The risk of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with prescription cough and cold medicines containing codeine or hydrocodone outweighs their benefits in patients younger than 18.
That is the stance being taken by the US Food and Drug Administration (FDA) as it demands safety labeling changes to limit the use of these products to adults only.
The FDA is also requiring the addition of safety information about the risks that these medicines pose to the Boxed Warning, the agency’s most prominent warning.
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