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)

 July 2013 – September 2013

 

 Postmarket Drug and Biologic Safety Evaluations Completed from 
July 2013 through September 2013  

 

New Molecular Entities and Biological Products   

Product Name: Trade (Active Ingredient) NDA/BLA Number Approval Date	Major Indication(s)	Summary of Evaluation Findings	Actions Taken and Ongoing Surveillance Activities
Kedbumin (Albumin (Human)) BLA 125384 June 3, 2011	Treatment of: hypovolemia; hypoalbuminemia; Ovarian Hyperstimulation Syndrome (OHSS); Adult Respiratory Distress Syndrome (ARDS); burns; hemodialysis patients undergoing long term dialysis or who cannot tolerate substantial volumes of salt solution; prevention of central volume depletion after paracentesis due to cirrhotic ascites; in cardiopulmonary bypass as part of the priming fluids.	No new safety concerns were identified.	No regulatory action required at this time.
Xarelto (Rivaroxaban)  NDA 022406  July 1, 2011	For the reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. For the treatment of deep vein thrombosis (DVT). For the treatment of pulmonary embolism (PE). For the reduction in the risk of recurrence of deep vein thrombosis and of pulmonary embolism following initial 6 months treatment for DVT and/or PE.	Adverse event reports of thrombocytopenia and venous thromboembolic events were identified.	FDA is continuing to evaluate thrombocytopenia and thromboembolic events to determine if regulatory action is required.
Zytiga (Abiraterone) NDA 202379 April 28, 2011	For the treatment of patients with metastatic castration-resistant prostate cancer in combination with prednisone.	Adverse event reports of pneumonitis, pulmonary embolism and rhabdomyolysis events were identified.	FDA is continuing to evaluate pneumonitis, pulmonary embolism and rhabdomyolysis 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 Findings	Actions Taken and Ongoing Surveillance Activities
Actoplus Met XR (Pioglitazone HCl and metformin HCl) extended-release NDA 022024 May 12, 2009	As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with pioglitazone and metformin or who have inadequate glycemic control on pioglitazone alone or metformin alone.	No new safety concerns were identified.	No regulatory actions required at this time.
Caldolor (Ibuprofen) injection NDA 022348 June 11, 2009	For the management of:   – mild to moderate pain in adults    – moderate to severe pain in adults as an adjunct to opioid analgesics. For the reduction of fever in adults.	Adverse event reports of infusion-site reactions were identified.	FDA is continuing to evaluate infusion-site reactions to determine if regulatory action is required.
Combivent Respimat (Albuterol sulfate / ipratropium bromide) NDA 021747 October 7, 2011	For use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.	No new safety concerns were identified.	No regulatory actions required at this time.
Cycloset (Bromocriptine mesylate) NDA 020866 May 5, 2009	As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.	No new safety concerns were identified.	No regulatory actions required at this time.
Edarbyclor (Azilsartan kamedoxomil and chlorthalidone) NDA 202331 December 20, 2011	For the treatment of hypertension, to lower blood pressure:    – in patients not adequately controlled with monotherapy   – as initial therapy in patients likely to need multiple drugs to help achieve blood pressure goals.	Adverse event reports of decreased blood sodium/hyponatremia and angioedema were identified.	FDA is continuing to evaluate decreased blood sodium/hyponatremia and angioedema to determine if regulatory action is required.
Gemcitabine HCl injection, USP   NDA 200795   August 4, 2011	For the treatment of patients with: Ovarian Cancer: In combination with carboplatin of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. Breast Cancer: First-line treatment in combination with paclitaxel of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. Non-Small Cell Lung Cancer: First-line treatment in combination with cisplatin of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer. Pancreatic Cancer: First-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas.	No new safety concerns were identified.	No regulatory actions required at this time.