The FDA Drug Safety Communications posted on this web page are intended to provide important information to patients and health care professionals about new safety issues with the medicines they are taking or prescribing so they can make more informed decisions about treatment.
Widespread or long-term use of drugs by patients may uncover side effects not discovered during the clinical trials a drug company did to get FDA approval of the medicine. As a result, FDA physicians and scientists continue to monitor the safety of drugs after they are approved. When we learn information about a potential new safety issue, we review the data from available clinical trials or other studies, case reports, and medical literature. Based on what we find, we may require changes to the prescribing information or the patient Medication Guide. We may also release a Drug Safety Communication to alert patients and health care professionals about the issue.
You can get new safety information on medicines you’re prescribing or taking by signing up for email alerts about Drug Safety Communications on types of drugs or medical specialties of specific interest to you.
Current Drug Safety Communications
- 01-19-2024 FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
- 01-11-2024 Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
- 11/28/2023 FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
- 05/11/2023 FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
- 04/13/2023 FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use
Previous Drug Safety Communications
Additional Resources For You
- Development & Approval Process (Drugs)
- How Drugs are Developed and Approved
- The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
- Frequently Asked Questions about the FDA Drug Approval Process
- Think It Through: Managing the Benefits and Risks of Medicines
- CDER Conversation: CDER's Drug Safety Communications: Ensuring postmarket safety
- Drus@FDA: FDA-Approved Drugs