Postmarket Drug and Biologic Safety Evaluations
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:
The product's pre-approval safety profile
The product's current FDA-approved label
Reports made to the FDA Adverse Event Reporting System (FAERS), previously known as AERS
Reports made to the Vaccine Adverse Event Reporting System (VAERS)
Manufacturer-submitted periodic safety reports
Medical literature
Drug utilization databases
Data from post-approval clinical trials and other studies, when applicable
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 July 1, 2016 to September 30, 2016
| 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 |
|---|---|---|---|
Acticlate (doxycycline hyclate) tablets, for oral use NDA 205931 July 25, 2014 | For treating:
For use as:
| No new safety issues were identified. | No regulatory actions required at this time. |
Arnuity Ellipta (fluticasone furoate inhalation powder) for oral inhalation NDA 205625 August 20, 2014 | For the once-daily maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older | No new safety issues were identified. | No regulatory actions required at this time. |
Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye NDA 206289 July 18, 2014 |
| No new safety issues were identified. | No regulatory actions required at this time. |
Belsomra (suvorexant) tablets, for oral use NDA 204569 (NME) August 13, 2014 | For treating insomnia characterized by difficulties with sleep onset and/or sleep maintenance | Two safety issues were identified from postmarketing adverse event reports:
| FDA continues to evaluate adverse event reports of paradoxical reactions and worsening insomnia to determine if regulatory action is required. |
Bunavail (buprenorphine and naloxone) buccal film NDA 205637 June 6, 2014 | For the maintenance treatment of opioid dependence | Two safety issues were identified from postmarketing adverse event reports:
| FDA continues to evaluate adverse event reports of product quality issues and inadequate dose conversion to determine if regulatory action is required. |
Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets NDA 200063 September 10, 2014 | For use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
| Two safety issues were identified from postmarketing adverse event reports:
| FDA continues to evaluate adverse event reports of loss of consciousness and abuse to determine if regulatory action is required. |
Desvenlafaxine extended-release tablet, for oral use NDA 204150 March 4, 2013 | For treating major depressive disorder (MDD) | No new safety issues were identified. | No regulatory actions required at this time. |
Eylea (aflibercept) injection, for intravitreal injection BLA 125387 (NME) November 18, 2011 | For treating:
| No new safety issues were identified. | No regulatory actions required at this time. |
Flonase Allergy Relief (fluticasone proprionate) nasal spray NDA 205434 July 23, 2014 | For the temporary relief of symptoms due to hay fever or other upper respiratory allergies, including:
| No new safety issues were identified. | No regulatory actions required at this time. |
Jublia (efinaconazole) topical solution, 10% NDA 203567 (NME) June 6, 2014 | For the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes | No new safety issues were identified. | No regulatory actions required at this time. |
Kerydin (tavaborole) topical solution, 5% NDA 204427 (NME) July 7, 2014 | For the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes | No new safety issues were identified. | No regulatory actions required at this time. |
Mozobil (plerixafor) injection, for subcutaneous use NDA 022311 (NME) December 15, 2008 | For use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma | No new safety issues were identified. | No regulatory actions required at this time. |
Nymalize (nimodipine) oral solution NDA 203340 May 10, 2013 | For improving neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V) | No new safety issues were identified. | No regulatory actions required at this time. |
Ofev (nintedanib) capsule, for oral use NDA 205832 (NME) October 15, 2014 | For treating idiopathic pulmonary fibrosis (IPF) | No new safety issues were identified. | No regulatory actions required at this time. |
Pennsaid (diclofenac sodium) topical solution, 2% w/w, for topical use NDA 204623 January 16, 2014 | For treating the pain of osteoarthritis of the knee(s) | No new safety issues were identified. | No regulatory actions required at this time. |
Phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10% NDA 203510 March 21, 2013 | For dilating the pupil | No new safety issues were identified. | No regulatory actions required at this time. |
Promacta (eltrombopag) tablets, for oral use NDA 022291 (NME) November 20, 2008 | For treating:
| No new safety issues were identified. | No regulatory actions required at this time. |
Tanzeum (albiglutide) for injection, for subcutaneous use BLA 125431 (NME) April 15, 2014 | For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | Three safety issues were identified from postmarketing adverse event reports:
| FDA continues to evaluate adverse event reports of incorrect techniques of product preparation and administration, as well as pen leakage during administration to determine if regulatory action is required. |
Vazculep (phenylephrine hydrochloride) injection for intravenous use NDA 204300 June 27, 2014 | For treating clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia | One safety issue of product selection error between Vazculep (phenylephrine hydrochloride) and Bloxiverz (neostigmine methylsulfate) was identified from postmarketing adverse event reports. | FDA continues to evaluate medication error reports of wrong product selection to determine if regulatory action is required. |
Zyrtec Allergy (cetirizine hydrochloride) orally disintegrating tablets NDA 022578 September 3, 2010 | For the temporary relief of symptoms due to hay fever or upper respiratory allergies, including:
| No new safety issues were identified. | No regulatory actions required at this time. |
Previous Postmarket Drug and Biologic Safety Evaluation Summaries
April 2016 – June 2016 January 2016 – March 2016 - October 2015 – December 2015
July 2015 – September 2015 April 2015 – June 2015 January 2015 - March 2015 - October 2014 - December 2014
- July 2014 – September 2014
- April 2014 – June 2014
- January 2014 – March 2014
- October 2013 – December 2013
- July 2013 – September 2013
- April 2013 – June 2013
- January 2013 - March 2013
- July 2012 – December 2012
- January 2012 – June 2012
- July 2011 – December 2011
- January 2011 – June 2011
- October 2010 – December 2010 (updated 11/2012)
- January 2010 – September 2010 (updated 5/2011)
- September 2007 – December 2009 [ARCHIVED]
Related Information
Questions and Answers on FDA’s Postmarketing Safety Summaries of Recently Approved Drugs and Biologics
6/15/2010FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals [ARCHIVED]
FDA press release (6/15/2010)FDA Fact Sheet: FDAAA 2007 Section 915 - Enhancing FDA’s Safety Reporting on Recently Approved Therapies (PDF - 53KB)
6/15/2010Postmarket Drug Safety Information for Patients and Providers Postmarketing Safety Evaluation of New Molecular Entities: Final Report
10/15/2009