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U.S. Department of Health and Human Services

Drugs

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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 2013 - December 2013

 

 Postmarket Drug and Biologic Safety Evaluations Completed from 
October 2013 through December 2013  

 

 

New Molecular Entities and Biological Products   

Product Name: Trade
(Active Ingredient)
NDA/BLA Number
Approval Date
Major Indication(s)Summary of Evaluation FindingActions Taken and Ongoing Surveillance Activities

Afinitor
(Everolimus)

NDA 022334

March 30, 2009

For the treatment of patients with:

Breast Cancer:
In postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.

Pancreatic Cancer:
In adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic.  Afinitor is not indicated for the treatment of patients with functional carcinoid tumors.

Renal Cancer:
In adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.

In adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery.

In pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected.

Adverse event reports of liver failure, pulmonary hypertension, and Pneumocystis jiroveci pneumonia were identified.

Adverse event and literature reports of heart failure and left ventricular dysfunction were identified.

Medication error reports of wrong technique were identified.

FDA is continuing to evaluate liver failure, pulmonary hypertension, Pneumocystis jiroveci pneumonia, heart failure, left ventricular dysfunction, and medication error reports of wrong technique events to determine if regulatory actions are required.

Ella
(Ulipristal acetate)

NDA 022474

August 13, 2010

Emergency contraceptive for the prevention of pregnancy following unprotected intercourse of a known or suspected contraception failure.

Not intended for routine use as a contraceptive.

Adverse event reports of exposure during pregnancy and use beyond the recommended time frame of 5 days (120 hours) after unprotected intercourse were identified.

No regulatory action required at this time.

Ixempra
(Ixabepilone)

NDA 022065

October 16, 2007

For the treatment of patients with breast cancer:

In combination with capecitabine in patients with metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane.

As monotherapy in patients with metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine.

No new safety concerns were identified.

No regulatory action required at this time.

Onfi
(Clobazam)

NDA 202067

October 21, 2011

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

Adverse event reports of urinary retention and hypothermia, some possibly associated with shock, were identified.

FDA is continuing to evaluate urinary retention and hypothermia events to determine if regulatory action is required.

 

All Other Products   

Product Name: Trade
(Active Ingredient
NDA/BLA Number
Approval Date
Major Indication(s)Summary of Evaluation FindingsActions Taken and Ongoing Surveillance Activities

Gelnique
(Oxybutynin) gel, 3%

NDA 202513

December 7, 2011

For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Adverse event reports of hallucination in pediatric and elderly patients were identified.

FDA is continuing to evaluate hallucination events to determine if regulator action is required.

Lamisil oral granules
(Terbinafine hydrochloride)

NDA 022071

September 28, 2007

For the treatment of tinea capitis in patients 4 years of age and older.

No new safety concerns were identified.

No regulatory action required at this time.

Morphine sulfate injection, USP

NDA 202515

November 14, 2011

For the management of pain not responsive to non-narcotic analgesics.

No new safety concerns were identified.

No regulatory action required at this time.

Neudexta
(Dextromethorphan plus quinidine)

NDA 021879

October 29, 2010

For the treatment of pseudobulbar affect.

No new safety concerns were identified.

No regulatory action required at this time.

Opana ER
(Oxymorphone hydrochloride) extended-release tablets

NDA 201655

December 9, 2011

For the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

Adverse event reports of anaphylactic reactions and rash were identified

FDA is continuing to evaluate anaphylactic reactions and rash events to determine if regulatory actions are required.

Sklice lotion, 0.5%
(Ivemectin)

NDA 202736

February 7, 2012

For the topical treatment of head lice infestations in patients 6 month of age and older.

No new safety concerns were identified.

No regulatory action required at this time.