Drugs

Postmarket Drug and Biologic Safety Evaluations

What is FDA posting?

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 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, the report will be presented in two tables. The first table lists 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), and all biological products. The second table lists all other 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 April 1, 2016 to June 30, 2016
Product Name: Trade (active ingredient)
with Dosage form NDA/BLA Number ("NME" indicates New Molecular Entity)  Approval Date
Major IndicationsSummary of Findings from EvaluationActions taken and Ongoing Surveillance Activities

Asmanex HFA
(mometasone furoate) inhalation aerosol, for oral inhalation

NDA 205641

April 25, 2014

For 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.

Bivigam

(immune globulin intravenous (human), 10% liquid)

BLA 125389

December 19, 2012

For treating primary humoral immune deficiency.No new safety issues were identified.No regulatory action is required at this time.

Farxiga (dapagliflozin) tablet, for oral use

NDA 202293 (NME)

January 8, 2014

 

For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Adverse event reports of acute kidney injury and severe dehydration were identified.FDA updated the “Warnings and Precautions” section of the package insert and the Medication Guide to include information about the risk of acute kidney injury. FDA continues to monitor for adverse event reports of severe dehydration to determine if further evaluation is required.

Forfivo XL (bupropion hydrochloride) extended-release tablet, for oral use

NDA 022497

November 10, 2011

For treating patients with major depressive disorder.A potential signal for abuse by inappropriate routes of administration was identified.FDA is evaluating the need for regulatory action.

Granix (tbo filgrastim) injection, for subcutaneous use

BLA 125294 (NME)

August 29, 2012

For reducing the duration of severe neutropenia in patients with non-myeloid malignancies who receive myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Five safety issues were identified from postmarketing adverse event reports:

  • Kidney injury (glomerulonephritis)
     
  • Acute febrile neutrophilic dermatosis (Sweet syndrome)
  • Asthenia
  • Diarrhea
  • Fatigue
FDA is evaluating the need for regulatory action.

Nexium 24HR (esomeprazole magesium) delayed-release capsule, for oral use

NDA 204655

March 28, 2014

For treating frequent heartburn (occurs 2 or more days a week) in adults 18 years of age and older.

No new safety issues were identified.

No regulatory actions required at this time.

Onfi (clobazam) oral suspension

NDA 203993

December 14, 2012

For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

No new safety issues were identified.

No regulatory actions required at this time.

Otezla (apremilast) tablet, for oral use

NDA 205437 (NME)

March 21, 2014

For treating:

  • Adult patients with active psoriatic arthritis
  • Patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

No new safety issues were identified.

No regulatory actions required at this time.

Oxtellar XR (oxcarbazepine) extended-release tablet, for oral use

NDA 202810

October 19, 2012

  • For use as an adjunctive therapy in the treatment of partial seizures in adults.
  • For use as an adjunctive therapy in the treatment of partial seizures in children 6 years of age to 17 years of age.

No new safety issues were identified.

No regulatory actions required at this time.

Sodium chloride injection, USP, 0.9%

NDA 202832

January 6, 2012

For diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injections.

No new safety issues were identified.

No regulatory actions required at this time.

Xartemis XR (oxycodone hydrochloride and acetaminophen) extended-release tablet, for oral use

NDA 204031

March 11, 2014

For managing acute pain for which non-opioid analgesics are inadequate.

No new safety issues were identified.

No regulatory actions required at this time.

Xtandi (enzalutamide) capsule, for oral use

NDA 203415 (NME)

August 31, 2012

For treating patients with metastatic castration-resistant prostate cancer.

Five safety issues were identified from postmarketing adverse event reports:

  • Hypersensitivity
  • Anemia
  • Rash
  • Nausea
  • Vomiting
FDA continues to evaluate adverse event reports of hypersensitivity, anemia, rash, nausea, and vomiting to determine if regulatory action is required.

 

Page Last Updated: 10/04/2016
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