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                Drug Safety and Availability

Drug Safety and Availability

                        Drug Alerts and Statements
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          Multistate outbreak of fungal meningitis and other infections Home
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          Drug Safety CommunicationsDrug Safety and Availability Drug Safety Communications
  
  	
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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.

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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 usePrevious Drug Safety Communications

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
	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 DrugsSome Drug Safety Communications (DSCs) posted from 2010 to 2015 have been archived because FDA issued newer DSCs with updated information about the medicine. To access these archived DSCs, visit the Way Back Archive.

                                                                                  Content current as of:
      01/19/2024
              
              
Regulated Product(s)
		 DrugsDrug Safety and Availability

          
                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections
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