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Postmarket Drug and Biologic Safety Evaluations

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Postmarketing Drug Safety Evaluation Summaries Completed from October 2010 through December 2010

Product Name: Trade (Active Ingredient) NDA/BLA Number Approval Date	Major Indication(s)	Summary of Evaluation Findings	Actions Taken and Ongoing Surveillance Activities
Akten (Lidocaine hydrochloride ophthalmic gel 3.5%) NDA 022221 October 7, 2008	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) NDA 022301 October 31, 2008	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) BLA 125160 April 22, 2008	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.	( 11/2012) The Dosage and Administration section of the labeling for Cimzia was updated August 2012, to include additional instructions about its preparation and administration. Certolizumab pegol (Cimzia) labeling approved 8/2/2012 (PDF - 376KB)
Epiduo (Adapalene and Benzoyl peroxide) NDA 022320 December 8, 2008	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) NDA 022204 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) BLA 125280 March 30, 2009	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) NDA 022285 September 12, 2008	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) NDA 022161 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 October 31, 2008	Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency in adults.	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 unlabeled or unexpected serious adverse events were identified.	No labeling changes required at this time.
Trilipix (Choline fenofibrate) 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.

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