Postmarket Drug and Biologic Safety Evaluations
UPDATE 11/6/2019
- FDA has posted a draft document titled “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.” This best practices document is required under a provision of the 21st Century Cures Act. The Act includes a revision to a previous statutory requirement that generally required FDA to undertake routine safety analyses of drugs 18 months following approval or after 10,000 individuals have used the drug, whichever occurs later. Comments will be accepted on this document through the related docket, as detailed in the Federal Register Notice.
- Due to the changes outlined in the draft best practices document, the content on this web page will be archived when the document is finalized.
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What information does FDA consider for these postmarket safety evaluations?
- How is the information analyzed?
- Postmarket Drug Safety Evaluation Summaries
This website provides summary information about ongoing and completed postmarket safety evaluations of adverse experience reports made to FDA for New Drug Applications (NDAs) and Biologics License Applications (BLAs) approved since September 27, 2007. The evaluations are done to determine if there are any new serious adverse events not previously identified during product development, known side effects reported in unusual number, or potential new safety concerns now that the products are being used in the general population. In accordance with Title IX, section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) which created a new section 505(r) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 355(r)), these postmarket evaluations are performed 18 months after approval of the drug or after its use by 10,000 individuals, whichever is later.
Why is FDA posting this summary information?
FDA is posting this information in accordance with section 505(r) of the FDCA. This section of the statute directs FDA to improve the transparency of information about drugs and to provide patients and health care providers better access to information about drugs by developing a website with specified types of drug safety information.
In response to the statutory requirement, FDA developed the Postmarket Drug Safety Information for Patients and Providers website, which has links to a wide variety of drug safety information, including this web page.
What information is provided on this website?
The table in each quarterly report lists the names of drug and biological products, application number, approval date, approved indication, summary of evaluation findings, actions taken, and ongoing surveillance activities. Beginning with the period from July 2012 to December 2012, drugs with an active moiety that has not been previously approved or legally marketed in the United States in any form (also known as New Molecular Entities) appear in the table and are marked as “NME.” The table also includes all biological products, including biosimilar products. Postmarket safety evaluation findings include potential new safety concerns that are first identified during the evaluation and should not be viewed as a summary of all safety issues addressed since the product's approval.
A new report will be made available each quarter beginning with the period from January 2013 to March 2013.
What information does FDA consider for these postmarket safety evaluations?
FDA assesses several data sources including:
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The product's pre-approval safety profile
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The product's current FDA-approved label
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Reports made to the FDA Adverse Event Reporting System (FAERS), previously known as AERS
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Reports made to the Vaccine Adverse Event Reporting System (VAERS)
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Manufacturer-submitted periodic safety reports
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Medical literature
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Drug utilization databases
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Data from post-approval clinical trials and other studies, when applicable
Please see the Drug and Biologics Safety Surveillance Best Practice Statement (PDF 79KB) for more information.
How is the information analyzed?
Beginning not later than 18 months after approval, scientists from the Office of Surveillance and Epidemiology and Office of New Drugs in the Center for Drug Evaluation and Research (CDER) jointly review the relevant data, summarize findings and, when necessary, develop a plan to further investigate potential new safety issues for products regulated by CDER. For medical products regulated by the Center for Biologics Evaluation and Research, this safety review and evaluation is conducted by scientists from CBER's Office of Biostatistics and Epidemiology and the relevant product office (Office of Blood Research and Review, Office of Vaccine Research and Review, or Office of Cellular, Tissue and Gene Therapies). FDA compiles the postmarket safety evaluations and periodically posts the summary reports on this website.
For additional information about postmarket drug and biologic safety issues, including FDA Safety Communications and web postings of Potential Signals of Serious Risks Identified from the FDA Adverse Event Reporting System (FAERS), please refer to FDA's website on Postmarket Drug Safety Information for Patients and Providers or Safety and Availability (Biologics).
Postmarket Drug and Biologic Safety Evaluation Summaries
(previous Postmarket Drug and Biologic Safety Evaluations)
Drug Safety Evaluations Completed From April 1, 2017 to June 30, 2017
Product Name: Trade (active ingredient) with Dosage form NDA/BLA Number ("NME" indicates New Molecular Entity) Approval Date |
Major Indications | Summary of Findings from Evaluation | Actions taken and Ongoing Surveillance Activities |
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Aptensio XR NDA 205831 April 17, 2015 |
For treating attention deficit hyperactivity disorder |
The potential safety issue of dystonia was identified from postmarketing adverse event reports. |
FDA continues to evaluate adverse event reports of dystonia to determine if regulatory action is required. |
Aptiom (eslicarbazepine acetate) NDA 022416 (NME) November 8, 2013 |
For treating partial-onset seizures as monotherapy or adjunctive therapy |
Three potential safety issues were identified from postmarketing adverse event reports:
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On September 13, 2017, an efficacy supplement for Aptiom was approved and included the addition of SIADH to the existing “Warnings and Precautions” subsection describing the risk for hyponatremia, and the addition of a new “Warnings and Precautions” subsection describing the risk for hematologic adverse reactions. It was determined that no regulatory actions related to atrioventricular block are required at this time. |
Bexsero BLA 125546 January, 23, 2015 |
For active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age |
No new safety issues were identified. |
No regulatory actions required at this time. |
Corlanor (ivabradine) tablets, for oral use NDA 206143 (NME) April 15, 2015 |
For reducing the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction less than or equal to 35 percent, who are in sinus rhythm with resting heart rate greater than or equal to 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use |
No new safety issues were identified. |
No regulatory actions required at this time. |
Epiduo Forte NDA 207917 July 15, 2015 |
For the topical treatment of acne vulgaris |
No new safety issues were identified. |
No regulatory actions required at this time. |
Gardasil 9 BLA 125508 December 10, 2014 |
Prevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18, 31, 33, 45, 52, and 58 and genital warts (condyloma acuminata) caused by HPV types 6 and 11 |
No new safety issues were identified. |
No regulatory action required at this time. |
Injectafer NDA 203565 July 25, 2013 |
An iron replacement product for treating iron deficiency anemia in adult patients:
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No new safety issues were identified. |
No regulatory actions required at this time. |
Jevtana (cabazitaxel) NDA 201023 (NME) June 17, 2010 |
For treating hormone-refractory metastatic prostate cancer |
The potential safety issue of tumor lysis syndrome was identified from postmarketing adverse event reports. |
FDA continues to evaluate adverse event reports of tumor lysis syndrome to determine if regulatory action is required. |
Noxafil NDA 205053 November 25, 2013 |
For use as a prophylaxis of invasive Aspergillus and Candida infections in patients (13 years of age and older) who are at high risk of developing these infections |
No new safety issues were identified. |
No regulatory actions required at this time. |
Opdivo (nivolumab), solution for injection BLA 125527, 125554 (NME) December 22, 2014 |
For treating:
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Three potential safety issues were identified from postmarketing adverse event reports:
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FDA continues to evaluate adverse event reports of retinal detachment, severe vision loss, and tumor lysis syndrome to determine if regulatory action is required. |
Otrexup NDA 204824 October 11, 2013 |
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Potential device-related safety issues were identified from postmarketing adverse event reports. |
No regulatory action required at this time. |
ProAir RespiClick (albuterol sulfate) inhalation powder, for oral inhalation use NDA 205636 March 31, 2015 |
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No new safety issues were identified. |
No regulatory actions required at this time. |
Tuzistra XR NDA 207768 April 30, 2015 |
For relief of cough symptoms associated with upper respiratory allergies or a common cold |
No new safety issues were identified. |
No regulatory actions required at this time. |
Velphoro NDA 205109 November 27, 2013 |
For the control of serum phosphorus levels in patients with chronic kidney disease on dialysis |
Two potential safety issues were identified from postmarketing adverse event reports:
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On August 3, 2017, a labeling supplement was approved that included the addition of information in the “Adverse Reactions; Postmarketing Experience” section of labeling pertaining to reports of tooth discoloration and rash. |
Zarxio BLA 125553 March 6, 2015 |
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No new safety issues were identified. |
No regulatory actions required at this time. |
Zortress NDA 021560 April 20, 2010 |
For the prophylaxis of organ rejection in adult patients |
No new safety issues were identified. |
No regulatory actions required at this time. |
Drug Safety Evaluations Completed July 1, 2017 to September 30, 2017
Product Name: Trade (active ingredient) with Dosage form NDA/BLA Number ("NME" indicates New Molecular Entity) Approval Date |
Major Indications | Summary of Findings from Evaluation | Actions taken and Ongoing Surveillance Activities |
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Finacea NDA 207071 July 29, 2015 |
For the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea |
No new safety issues were identified. |
No regulatory actions required at this time. |
Humalog (insulin lispro) injection, for subcutaneous or intravenous use NDA 205747 May 26, 2015 |
A concentrated (200 units/ml) rapid acting human insulin analog for improving glycemic control in adults and children with diabetes mellitus |
No new safety issues were identified. |
No regulatory actions required at this time. |
Ibrance (palbociclib) capsules, for oral use NDA 207103 (NME) February 3, 2015 |
For treating hormone receptor (HR)-positive, human epidermal growth receptor 2 (HER-2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women; or fulvestrant in women with disease progression following endocrine therapy |
No new safety issues were identified. |
No regulatory actions required at this time. |
Prezcobix NDA 205395 January 29, 2015 |
For use in combination with other antiretroviral agents for treating HIV-1 infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions |
No new safety issues were identified. |
No regulatory actions required at this time. |
Stiolto Respimat NDA 206756 May 21, 2015 |
For long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease |
No new safety issues were identified. |
No regulatory actions required at this time. |
Triumeq (abacavir, dolutegravir, and lamivudine) NDA 205551 August 22, 2014 |
For treating human immunodeficiency virus (HIV-1) infection |
The potential safety issue of anxiety was identified from postmarketing adverse event reports. |
FDA continues to evaluate adverse event reports of anxiety to determine if regulatory action is required. |
Viberzi (eluxadoline) NDA 206940 (NME) May 27, 2015 |
For treating irritable bowel syndrome with diarrhea in adults |
The potential safety issue of hypersensitivity reactions, including anaphylaxis, was identified from postmarketing adverse event reports. |
FDA continues to evaluate adverse event reports of hypersensitivity reactions, including anaphylaxis, to determine if regulatory action is required. |
Previous Postmarket Drug and Biologic Safety Evaluation Summaries
- January 2017 â March 2017
- October 2016 â December 2016
- July 2016 â September 2016
- April 2016 â June 2016
- January 2016 â March 2016
- October 2015 â December 2015
- July 2015 â September 2015
- Previous Postmarket Drug and Biologic Safety Evaluation Summaries: April 2015 â June 2015
- January 2015 - March 2015
- October 2014 - December 2014
- July 2014 â September 2014
- April 2014 â June 2014
- January 2014 â March 2014
- October 2013 â December 2013
- July 2013 â September 2013
- April 2013 â June 2013
- January 2013 - March 2013
- July 2012 â December 2012
- January 2012 â June 2012
- July 2011 â December 2011
- January 2011 â June 2011
- October 2010 â December 2010 (updated 11/2012)
- January 2010 â September 2010 (updated 5/2011)
- September 2007 â December 2009
Related Information
- Information on the 21st Century Cures Act
- Questions and Answers on FDAâs Postmarketing Safety Summaries of Recently Approved Drugs and Biologics
- FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals
- FDA Fact Sheet: FDAAA 2007 Section 915 - Enhancing FDAâs Safety Reporting on Recently Approved Therapies
- Postmarketing Safety Evaluation of New Molecular Entities: Final Report
- Test Table (Clean Code)