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Approved Risk Evaluation and Mitigation Strategies (REMS)

Qsymia (phentermine and topiramate)
NDA #022580
REMS last update: 02/06/2024



What is the purpose of the REMS?

To inform certified pharmacies and patients of reproductive potential about:
  1. The increased risk of embryo-fetal toxicity with major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being small for gestational age (SGA) in a fetus exposed to Qsymia during the first trimester of pregnancy
  2. The importance of pregnancy prevention for patients of reproductive potential receiving Qsymia
  3. The need to discontinue Qsymia immediately if pregnancy occurs

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
02/06/2024 Modified to revise Qsymia labeling to be consistent with Topamax (topiramate) labeling. Additional modification details can be found in the supplement approval letter at Drugs@FDA.
05/09/2023 Modified to make changes to the REMS to align with updated labeling from prior approval supplement (S-021), which added a new indication for pediatric patients aged 12 years and older with BMI in the 95th percentile or greater for standardized age and sex including: Global changes: new logo, updated product generic text, and updated language with respect to the indication, patient selection, and risk of teratogenicity to align with the updated labeling. Revisions to the REMS document and REMS materials to reflect the consolidation of the Pharmacy Enrollment Form. Revisions to the REMS document to update the method for completing pharmacy certification from “online and by phone” to “via fax or email” and remove the requirement to submit the Knowledge Assessment, located in the Qsymia REMS Pharmacy Training, to the REMS Program. Title change for the Pharmacy Training Program to the Qsymia REMS Pharmacy Training. Revisions to the newly consolidated Pharmacy Enrollment Form and Qsymia REMS Pharmacy Training to include updated attestations to align with the REMS document. Revisions to the REMS website.
03/08/2022 Modified to convert the REMS document to the new standardized format and provide the Applicant’s name change throughout the REMS Document and REMS materials. This modification also removes ETASU A, prescriber training, as an element of the REMS, updates the goals to reflect the removal of ETASU A, and removes the REMS materials associated with prescriber training.
03/31/2021 Modified to replace gender-specific language in the REMS document and REMS materials with gender-neutral language. This modification aligns the REMS document and REMS materials with changes previously made to the Qsymia prescribing information.
07/03/2017 Revised to make editorial changes.
09/26/2014 Modified to:

  1. Remove the requirement that The Dear Healthcare Provider letter be provided to MedWatch in the REMS document.
  2. Conform to the changes being made to the package insert. Specifically, the changes include updated data in the Healthcare Provider Training Program [online and print] and the Pharmacy Training Program [online and print], based on the final report for study OB-901, Fetal Outcomes Retrospective Topiramate Exposure Study (FORTRESS) in the REMS materials.
  3. Reformat of the table to list the acceptable contraception methods for females of reproductive potential in the Healthcare Provider Counseling Tool for Females of Reproductive Potential, the Healthcare Provider Training Program [online and print], and the Pharmacy Training Program [online and print].
04/16/2013 Modified to:

  1. Clarify dosing and administration instructions in the Medication Guide
  2. Revise the pharmacy certification ETASU expanding pharmacy enrollment requirements
  3. Revise the implementation system
11/01/2012 Modified to revise the facsimile number in the Qsymia Healthcare Provider Training program – Print Copy
07/17/2012 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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