Drug Safety Communications
Español 药物安全通讯 Drug Safety Podcasts
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. Read more.
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
- 08-28-2025 FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab)
- 08-27-2025 FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine
- 07-31-2025 FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use
- 06-30-2025 FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD
- 06-18-2025 FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system)
- 05-16-2025 FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)
- 01-22-2025 FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa)
Previous Drug Safety Communications
2024 | 2023 | 2022 | 2021 | 2020 | 2019 | 2018 | 2017 | 2016 | 2015 | 2014 | 2013 | 2012 | 2011 | 2010
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
- Think It Through: Managing the Benefits and Risks of Medicines
- CDER Conversation: CDER's Drug Safety Communications: Ensuring postmarket safety
- Drugs@FDA: FDA-Approved Drugs
- Find Information about a Drug