Postmarketing Drug Safety Evaluations

  

What is FDA posting?

This web site provides summary information about ongoing and completed postmarketing safety evaluations of adverse drug experience reports made to FDA for New Drug Applications (NDAs) and Biologic 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 postmarketing 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 web site with specified types of drug safety information.

In response to the statutory requirement, FDA developed the Postmarket Drug Safety Information for Patients and Providers web site, which has links to a wide variety of drug safety information, including this web page.

What information is provided on this web site?

The web site includes the table below which lists the names of products, application number, approval date, approved indication, summary of evaluation findings, and actions taken and ongoing surveillance activities.

What information does FDA consider for these postmarketing 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 FDA's Adverse Event Reporting System (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?

FDA analyses for the safety evaluations include:

Data mining analysis of all adverse event reports in the AERS or VAERS databases Review serious adverse event reports Medication error analysis Product utilization analysis Risk management review Analysis of post-approval safety data from clinical trials and other studies, when applicable

Beginning not later than 18 months after approval, scientists from CDER's Office of Surveillance and Epidemiology and Office of New Drugs jointly review the relevant data, summarize findings and, when necessary, develop a plan to further investigate potential new safety issues. 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 will compile the postmarket safety evaluations and post these summaries as quarterly reports going forward.

Postmarketing Drug Safety Evaluation Summaries

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 Postmarketing Drug Safety Evaluations completed from October 2010 through December 2010:   
 

Akten
(Lidocaine hydrochloride ophthalmic gel 3.5%)

A local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures. 

No unlabeled or unexpected serious adverse events were identified. No labeling changes required at this time.

Apriso
(Mesalamine)

For the maintenance of remission of ulcerative colitis in adults. No unlabeled or unexpected serious adverse events were identified.

No labeling changes required at this time.

Cimzia
(Certolizumab pegol)

For reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

For treatment of adults with moderately to severely active rheumatoid arthritis.

Adverse event reports of medication errors involving preparation and administration of Cimzia in vial form were identified and reviewed. FDA is continuing to evaluate this issue to determine if regulatory action is required.

Epiduo 
(Adapalene and Benzoyl peroxide)

For the topical treatment of acne vulgaris in patients 12 years of age and older.

No unlabeled or unexpected serious adverse events were identified. No labeling changes required at this time.

Gelnique
(Oxybutynin chloride)

January 27, 2009

Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. No unlabeled or unexpected serious adverse events were identified. No labeling changes required at this time.

Ixiaro 
(Japanese Encephalitis Virus, Vaccine, Inactivated, Adsorbed)

Prevention of disease caused by Japanese encephalitis virus in persons 17 years of age or older. No new safety concerns were identified. No labeling changes required at this time.

Keppra XR
(Levetiracetam)

For adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age or older with epilepsy. Adverse event reports of medication errors in patients who were switched from Keppra to Keppra XR were identified. FDA is continuing to evaluate this issue to determine if regulatory action is required.

Lexiscan
(Regadenoson)    

April 10, 2008

Lexiscan is a pharmacologic stress agent indicated for radionuclide perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

Serious adverse event reports of cardiovascular events, respiratory events, headache/migraine headache, and infusion site reactions were identified.

All non-cardiovascular event reports were reviewed and there was no association of the adverse events with Lexiscan.

No labeling changes required at this time.

FDA is continuing to evaluate cardiovascular events to determine if regulatory action is required.

Rapaflo
(Silodosin)  

NDA 022206 

October 8, 2008

An alpha-1 adrenergic receptor antagonist, indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). No unlabeled or unexpected serious adverse events were identified. No labeling changes required at this time.

Toviaz
(Fesoterodine fumarate)

NDA 022030

Serious adverse event reports of confusion, loss of consciousness, and seizure were identified.  A subsequent safety review found that all cases were confounded and there was no association of these serious adverse events with Toviaz.

Serious adverse event reports of angioedema, which had been previously identified, are now included in the Warnings and Precautions section of the labeling for Toviaz.

No labeling changes required at this time.

Triesence
(Triamcinolone acetonide injectable suspension)

NDA 022048 

November 29, 2007

Treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

Visualization during vitrectomy. No labeling changes required at this time.

Trilipix

NDA 022224 

December 15, 2008

In combination with a statin to reduce triglycerides and increase HDL cholesterol in patients with mixed dyslipidemia and coronary heart disease or a coronary heart disease risk equivalent who are on optimal statin therapy to achieve their LDL cholesterol goal.

As monotherapy to reduce triglycercides in patients with severe hypertriglyceridemia.

As monotherapy to reduce high LDL cholesterol, total cholesterol, triglycerides and Apo B, and to increase HDL cholesterol in patients with primary hyperlipidemia or mixed dyslipidemia.

Adverse event reports of hepatic failure were identified and reviewed.  None of these cases were fatal, and FDA determined that liver injury is adequately described in the current label. 

Adverse event reports of paradoxical decreases in high-density lipoprotein cholesterol were also noted.  These cases lacked clinical details and information regarding concomitant drug use.

No labeling changes required at this time.

FDA is continuing to evaluate the issue of paradoxical decreases in high-density lipoprotein cholesterol to determine if regulatory action is required.
 

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