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)

New!  October — December 2014

 Postmarket Drug and Biologic Safety Evaluations Completed from 
October - December 2014  
Product Name: Trade (active ingredient)
NDA/BLA Number
Approval Date
Major IndicationsSummary of Findings from EvaluationActions taken and Ongoing Surveillance Activities
Flublok
(Influenza Vaccine)
BLA 125285
01/16/13

Active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
Flublok is approved for use in persons 18 years of age and older.

Adverse event reports of hypersensitivity reactions were identified.

On 10/29/14, FDA approved a revision to the Adverse Reactions section of the product label to include anaphylaxis, anaphylactoid reactions, allergic reactions, and other forms of hypersensitivity.

Flucelvax
(Influenza Vaccine)
BLA 125408
11/20/2012

Active immunization for the preventing influenza disease caused by influenza virus subtypes A and type B contained in the vaccine in persons 18 years of age and older

No new safety issues were identified.

No regulatory actions required at this time.

Gablofen
(baclofen injection)
NDA 022462
11/19/2010

Managing severe spasticity of cerebral or spinal origin in adult and pediatric patients, age 4 years and above

No new safety issues were identified.

No regulatory actions required at this time.

Kazano
(alogliptin/metformin)
Tablets
NDA 203414
01/25/2013

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

No new safety issues were identified.

No regulatory actions required at this time.

Linzess (linaclotide)
Capsules
NDA 202811 (NME)
08/30/2012
  • Treating irritable bowel syndrome with constipation (IBS-C)
  • Treating chronic idiopathic constipation (CIC)

No new safety issues were identified.

No regulatory actions required at this time.

Luvox
(fluvoxamine maleate)
Tablets
NDA 021519
12/20/2007

Treating obsessive-compulsive disorder

No new safety issues were identified.

No regulatory actions required at this time.

Oseni (alogliptin/pioglitazone)
Tablets
NDA 022426
01/25/2013

As an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes

No new safety issues were identified.

No regulatory actions required at this time.

Quillivant XR (methylphenidate HCl)
Powder for Oral Suspension
NDA 202100
09/27/2012

Treating Attention Deficit Hyperactivity Disorder (ADHD)

Lack of effect was identified as a new potential issue.

FDA is continuing to evaluate a potential lack of effect issue to determine if regulatory action is required.

Sodium Nitrite Injection
NDA 203922
02/14/2012

Sequential use with Sodium Thiosulfate treating acute cyanide poisoning that is judged to be life-threatening

No new safety issues were identified.

No regulatory actions required at this time.

Sodium Thiosulfate Injection
NDA 203923
02/14/2012

Sequential use with sodium nitrite for treating acute cyanide poisoning that is judged to be life-threatening

No new safety issues were identified.

No regulatory actions required at this time.

Xeljanz (tofacitinib)
Tablet
NDA 203214 (NME)
11/06/2012

Treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).

No new safety issues were identified.

No regulatory actions required at this time.

 

Page Last Updated: 04/29/2015
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