FDA is warning consumers about the risk of serious bleeding when using over-the-counter aspirin-containing antacid products to treat heartburn. The agency also issued a separate warning about loperamide (Imodium, Johnson & Johnson), saying that abuse or misuse of the product can cause serious heart problems that can lead to death.
There's a growing need for improved access to medication-assisted treatment among patients with opioid use disorder, according to a new study presented at the American Society of Addiction Medicine 47th Annual Conference.
FDA issued a draft guidance to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF), while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.
A month after FDA announced several measures aimed at curbing opioid abuse, the agency said it would require a new boxed warning addressing the serious risk of misuse, abuse, addiction, overdose and death on immediate-release (IR) opioid pain medications.
After receiving pressure from Congress, FDA announced several measures aimed at curbing opioid abuse. The new plan calls for increasing abuse-deterrent formulations of opioid medications and upping access to naloxone and alternative pain treatments.