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Questions and Answers on FDA’s Postmarketing Safety Summaries of Recently Approved Drugs and Biologics

Postmarket Drug and Biologic Safety Evaluations

What is FDA Posting?
Why is FDA posting this summary information?
What information is provided on this website?
What information does FDA consider for these postmarket safety evaluations?
How is the information analyzed?
Postmarket Drug Safety Evaluation Summaries

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.

Note: For the purposes of this website, all further references to drugs means human drug and biologic products regulated by CDER or CBER, unless otherwise specified.

What information is provided on this website?

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

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 Safety Evaluation Summaries

(previous Postmarket Drug Safety Evaluations)

New! Postmarket Drug Safety Evaluations completed from January 2012 through June 2012:

Product Name: Trade (Active Ingredient) NDA/BLA Number Approval Date	Major Indication(s)	Summary of Evaluation Findings	Actions Taken and Ongoing Surveillance Activities
Agriflu (Influenza Virus Vaccine) BLA 125297 November 27, 2009	Active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.	No new safety concerns were identified.	No regulatory actions required at this time.
Asclera (Polidocanol) NDA 021201 March 30, 2010	To sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Atelvia (Risedronate sodium) NDA 022560 October 8, 2010	For the treatment of osteoporosis in postmenopausal women.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Butrans (Buprenorphine transdermal system) NDA 021306 June 30, 2010	For the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Cambia (Diclofenac potassium) NDA 022165 June 17, 2009	For the acute treatment of migraine attacks with or without aura in adults 18 years of age or older.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Cefepime for injection, USP and Dextrose injection USP in Duplex Container, for intravenous use (Cefepime hydrochloride) NDA 050821 May 6, 2010	For the treatment of the following infections caused by susceptible strains of the designated microorganisms: Moderate to severe pneumonia; empiric therapy for febrile neutropenic patients; uncomplicated and complicated urinary tract infections; moderate to severe uncomplicated skin and skin structure infections; and complicated intra-abdominal infections (used in combination with metronidazole)	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Cervarix [Human Papillomavirus Bivalent (types 16 and 18) Vaccine, recombinant] BLA 125259 October 16, 2009	Active immunization of females 9 through 25 years of age for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18: cervical cancer; cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ; and cervical intraepithelial neoplasia (CIN) grade 1.	No new safety concerns were identified.	No regulatory actions required at this time.
Cetraxal (Ciprofloxacin otic solution) 0.2% NDA 021918 May 1, 2009	For the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Differin (Adapalene) NDA 022502 March 17, 2010	For the topical treatment of acne vulgaris in patients 12 years and older.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Exalgo (Hydromorphone HCl) NDA 021217 March 1, 2010	For the management of moderate to severe pain.	Adverse event reports of serotonin syndrome, anaphylactic shock and other allergic and hypersensitivity reactions, and medication errors were identified.	The adverse reactions section of the labeling for Exalgo was updated in August 2012 to include additional information about urticaria. FDA is continuing to evaluate serotonin syndrome, anaphylactic shock and other allergic and hypersensitivity reactions, and medication errors to determine if further regulatory action is required.
Hizentra (Immune Globulin Subcutaneous (Human) 20% Liquid) BLA 125350 March 4, 2010	For the treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.	No new safety concerns were identified.	No regulatory actions required at this time.
Jalyn (Dutasteride and tamsulosin HCl) NDA 022460 June 14, 2010	For the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Lastacaft (Alcaftadine ophthalmic solution) NDA 200603 October 28, 2010	For the prevention of itching associated with allergic conjunctivitis.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM₁₉₇Conjugate Vaccine) BLA 125300 February 19, 2010 (ages 11-55 years) January 28, 2011 (ages 2-10 years)	Active immunization to prevent invasive meningococcal disease caused by Neiseria meningitides serogroups A, C, Y and W-135 when administered to individuals 2 through 55 years of age.	No new safety concerns were identified.	No regulatory actions required at this time.
Natazia (Estradiol valerate and estradiol valerate/dienogest) NDA 022252 May 6, 2010	For the prevention of pregnancy. For the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Norvir (Ritonavir) NDA 022417 February 10, 2010	For the treatment of HIV in combination with other anti-retroviral agents.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Nucynta (Tapentadol HCl) NDA 022304 November 20, 2008	For the relief of moderate to severe acute pain in patients 18 years of age or older.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Oleptro (Trazodone HCl) NDA 022441 February 2, 2010	For the treatment of major depressive disorder (MDD) in adults.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Orabloc (Articaine) NDA 022466 February 26, 2010	For local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Oravig (Miconazole) NDA 022404 April 16, 2010	For the local treatment of oropharyngeal candidiasis in adults.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
OxyContin (Oxycodone HCl) NDA 022272 April 5, 2010	For the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.	Adverse event reports of choking, intestinal obstruction, medication residue in the stool, GI bleeding, and lack of (or reduced) efficacy were identified.	The Dosage and Administration section of the labeling for OxyContin was updated in November 2010 to include additional information to ensure complete swallowing. The Warnings and Precautions section of the labeling for OxyContin was updated October 2011 to include additional information about difficulty swallowing and gastrointestinal effects. FDA is continuing to evaluate choking, intestinal obstruction, medication residue in the stool, GI bleeding, and lack of (or reduced) efficacy issues to determine if further regulatory action is required.
Pancreaze (Pancrelipase (amylase, lipase, protease)) NDA 022523 April 12, 2010	For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine, Diphtheria CRM₁₉₇ Protein) BLA 125324 December 30, 2011	Active immunization for children 6 weeks through 5 years of age (prior to the 6^th birthday) for the prevention of invasive disease caused by Streptococcus Pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, and for the prevention of otitis media caused by Streptococcus Pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F	Adverse event reports of cyanosis, pallor, and hypotonia were identified. Adverse event reports of Kawasaki disease were identified.	FDA is continuing to evaluate the cyanosis, pallor, and hypotonia events to determine if the current labeling, which includes Hypotonic hyporesponsive episode (HHE) in the Adverse Reactions section, is adequate. FDA intends to initiate a larger study of Kawasaki’s disease risk following PCV13 vaccination in the Post-licensure Rapid Immunization Monitoring System.
Prilosec (Omeprazole magnesium) NDA 022056 March 20, 2008	Adults: For the treatment of duodenal ulcer, gastric ulcer and Pathological Hypersecretory Conditions; For the treatment of patients with H. pylori infection and duodenal ulcer disease in combination with clarithromycin plus/minus amoxicillin. Adults and children: For the treatment of gastroesophageal reflux disease (GERD) and treatment and/or maintenance of healing of erosive esophagitis.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Prolia (Denosumab) BLA 125320 June 1, 2010	For the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. To increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.	Adverse event reports of suppression of bone turnover, severe hypocalcemia, elevated parathyroid (PTH) levels, influenza-like illness, and medication errors were identified. Reproductive/developmental toxicity identified in animal studies.	The Contraindications and Use in Specific Populations sections of the labeling for Prolia were updated in May 2012 to include information about fetal harm if Prolia is administered to a pregnant woman and to change the pregnancy category to “X.” The Adverse Reactions section of the labeling for Prolia was updated in May 2012 to include additional information about severe hypocalcemia. FDA is continuing to evaluate suppression of bone turnover, elevated parathyroid (PTH) levels, influenza-like illness, and medication errors issues to determine if regulatory action is required.
Sprix (Ketorolac tromethamine) nasal spray NDA 022382 May 14, 2010	For the short term (up to 5 days) management of moderate to moderately severe pain.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Staxyn (Vardenafil HCl) NDA 200179 June 17, 2010	For the treatment of erectile dysfunction.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Suprep (Sodium sulfate, potassium sulfate, magnesium sulfate) NDA 022372 August 5, 2010	For cleansing of the colon in preparation for colonoscopy in adults.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
TobraDex ST (tobramycin and dexamethasone) ophthalmic suspension 0.3%/0.05% NDA 050818 February 13, 2009	For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Tribenzor (Olmesartan medoxomil, amlodipine and hydrochlorothiazide) NDA 200175 July 23, 2010	For the treatment of hypertension. Tribenzor is not indicated for initial therapy.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Veltin (Clindamycin phosphate and tretinoin) NDA 050803 July 16, 2010	For the treatment of acne vulgaris in patients 12 years or older.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Victoza (Liraglutide [rDNA origin] injection) NDA 022341 January 25, 2010	As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.	Adverse event reports of hypersensitivity reactions including anaphylaxis and necrotizing pancreatitis were identified. Increased risk of toxicity in patients who discontinue drug then restart drug at therapeutic doses without dose titration suggested by findings identified in animal studies. Reports involving improper pen storage, wrong injection technique, and device malfunctions were identified.	The Warnings and Precautions and Contraindications sections of the labeling for Victoza were updated in April 2012 to include additional information about serious hypersensitivity reactions including anaphylaxis. The Indications and Usage section of the labeling for Victoza was updated in April 2012 to include additional information about pancreatitis. FDA is continuing to evaluate pancreatitis to determine if further regulatory action is required. The Dosage and Administration section of the labeling for Victoza was updated in April 2012 to include additional information about resuming Victoza after a dose is missed. FDA is continuing to evaluate the patient instructions for use about improper pen storage, wrong injection technique, and device malfunctions.
Vimovo (Esomeprazole magnesium/naproxen) NDA 022511 April 30, 2010	For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patient at risk of developing NSAID-associated gastric ulcers.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Voluven (6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection) NDA BN070012 December 27, 2007	A plasma volume substitute indicated for the treatment and prophylaxis of hypovolemia in adults and children (It is not a substitute for red blood cells or coagulation factors in plasma).	In post-market clinical trials in adults with severe sepsis, patients treated with Voluven needed renal replacement therapy more often than patients treated with normal saline, although the difference was not statistically significant.	The Clinical Studies section of the labeling for Voluven was updated to include results of the post-market clinical trial, including information about kidney injury and the need for renal replacement therapy. FDA is continuing to evaluate this issue to determine if further regulatory action is required.
Xerese (acyclovir and hydrocortisone) topical cream 5%/1% NDA 022436 July 31, 2009	For the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older).	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Zyclara topical cream (Imiquimod) NDA 022483 March 25, 2010	For the topical treatment of clinically typical visible or palpable, actinic keratoses (AK), of the full face or balding scalp in immunocompetent adults. For the treatment of external genital and perianal warts/condyloma acuminate in patients 12 years or older.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.
Zymaxid (gatifloxacin ophthalmic solution) 0.5% NDA 022548 May 18, 2010	For the treatment of bacterial conjunctivitis.	No unlabeled or unexpected serious adverse events were identified.	No regulatory actions required at this time.

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