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        Drug Safety and Availability

Risk Evaluation and Mitigation Strategies | REMS

                        
                REMS Compliance Program
          What's in a REMS?
          Frequently Asked Questions (FAQs) about REMS
          Roles of Different Participants in REMS
          FDA’s Role in Managing Medication Risks
          REMS News, Education, Meetings and Improvement Efforts
          Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard Home
          Drugs
          Drug Safety and Availability
          Risk Evaluation and Mitigation Strategies | REMSDrug Safety and Availability Risk Evaluation and Mitigation Strategies | REMS
  	
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    PrintA Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS.

REMS are not designed to mitigate all the adverse events of a medication, these are communicated to health care providers in the medication’s prescribing information. Rather, REMS focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.

**REMS in Action: An Example**

Here is one example of a product that has a serious risk and a REMS. The set of REMS requirements were designed to make sure all patients receive special monitoring during the period when a side effect is most likely to occur so it can be detected and treated:

*Zyprexa Relprevv REMS*

Zyprexa Relprevv is a long-acting injectable anti-psychotic medication used to treat schizophrenia in adults. Zyprexa Relprevv can cause serious reactions following injection called post-injection delirium sedation syndrome. Symptoms, including feeling sleepier than usual (sedation), coma, and feeling confused or disoriented (delirium) occurred in clinical studies within 3 hours after treatment with Zyprexa Relprevv. The risk of post-injection delirium sedation syndrome is present with every injection, although it is a small risk - less than 1 percent.

To reduce the risk of post-injection delirium sedation syndrome, FDA required the manufacturer of Zyprexa Relprevv to develop a REMS. The purpose of the REMS is to ensure that the drug is administered only in certified health care facilities that can observe patients for at least three hours and provide the medical care necessary in case of an adverse event.

Currently Approved REMS

REMS@FDA

                                                                                  Content current as of:
      05/16/2023
                  
                   
Regulated Product(s)
		 DrugsRisk Evaluation and Mitigation Strategies | REMS                
                          

                        REMS Compliance Program
          What's in a REMS?
          Frequently Asked Questions (FAQs) about REMS
          Roles of Different Participants in REMS
          FDA’s Role in Managing Medication Risks
          REMS News, Education, Meetings and Improvement Efforts
          Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard
 
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