Drugs

Postmarket Drug and Biologic Safety Evaluations

Important Update [July 21, 2017]: Information FDA Considers During Postmarket Safety Evaluations (PDF 79KB).

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 quarterly 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, 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) appear in the table and are marked as “NME.” The table also includes all biological products, including biosimilar 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

Please see the Drug and Biologics Safety Surveillance Best Practice Statement (PDF 79KB) for more information.

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)

Drug Safety Evaluations Completed From January 1, 2017 to March 31, 2017
Product Name: Trade (active ingredient)
with Dosage form NDA/BLA Number ("NME" indicates New Molecular Entity)  Approval Date
Major IndicationsSummary of Findings from EvaluationActions taken and Ongoing Surveillance Activities

Cosentyx
(secukinumab)
injection, for subcutaneous use
 

BLA 125504 (NME)
 

January 21, 2015

For treating adults with:

  • Plaque psoriasis
  • Psoriatic arthritis
  • Ankylosing spondylitis

Five potential safety issues were identified from postmarketing adverse event reports:

  • Sepsis and infection-related deaths
  • Neutropenia-related serious infection
  • Eczema
  • Lichen planus/lichenoid mucositis
  • Medication errors and device-related events

FDA is evaluating adverse event reports of sepsis and infection-related deaths, neutropenia-related serious infection, eczema, lichen planus/lichenoid mucositis, medication errors, and device-related events to determine if regulatory action is required.

Cysview Kit
(hexaminolevulinate hydrochloride)
intravesical solution for bladder instillation only
 

NDA 022555
 

May 28, 2010

For cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy

No new safety issues were identified.

No regulatory actions required at this time.

Dysport
(abobotulinumtoxinA)
injection, for intramuscular use
 

BLA 125274 (NME)
 

April 29, 2009

For treating:

  • Cervical dystonia in adults
  • Upper limb spasticity in adults
  • Lower limb spasticity in pediatric patients 2 years of age and older
  • For cosmetic use to temporarily improve the appearance of moderate to severe glabellar lines

Two potential safety issues were identified from postmarketing adverse event reports:

  • Anaphylaxis
  • Dry eyes

FDA is evaluating adverse event reports of dry eyes to determine if regulatory action is required.
On June 14, 2017, a labeling supplement was approved that included the addition of information in the “Adverse Reactions; Postmarketing Experience” section of labeling pertaining to reports of hypersensitivity reactions, including anaphylaxis.

Edurant
(rilpivirine)
tablets, for oral use
 

NDA 202022 (NME)
 

May 20, 2011

For treating human immunodeficiency virus type 1 (HIV-1) infection, in combination with other antiretroviral agents, in treatment-naïve patients with HIV-1 ribonucleic acid or RNA less than or equal to 100,000 copies/milliliter

No new safety issues were identified.

No regulatory actions required at this time.

Epaned Kit
(enalapril maleate)
oral solution
 

NDA 204308
 

August 13, 2013

For treating:

  • Hypertension in adults and children older than one month
  • Symptomatic heart failure
  • Asymptomatic left ventricular dysfunction

No new safety issues were identified.

No regulatory actions required at this time.

Esomeprazole strontium
delayed-release
capsules, for oral use
 

NDA 202342
 

August 6, 2013

  • For treating gastroesophageal reflux disease in adults
  • For reducing risk of nonsteroidal anti-inflammatory drug-associated gastric ulcer in adults
  • For eradicating H. pylori to reduce the risk of duodenal ulcer recurrence in adults
  • For treating pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults

 

No new safety issues were identified.

No regulatory actions required at this time.

Glyxambi
(empagliflozin and linagliptin)
tablets, for oral use
 

NDA 206073
 

January 30, 2015

For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate

No new safety issues were identified.

No regulatory actions required at this time.

MenHibrix             (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)
 

BLA 125363
 

June 14, 2012

Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b

No new safety issues were identified.

No regulatory actions required at this time.

Meropenem for Injection USP and Sodium Chloride Injection USP in Duplex container, for intravenous use
 

NDA 202106
 

April 30, 2015

For treating:

  • Complicated skin and skin structure infections
  • Complicated intra-abdominal infections
  • Bacterial meningitis

No new safety issues were identified.

No regulatory actions required at this time.

Neostigmine methylsulfate 
injection, for intravenous use
 

NDA 203629
 

January 8, 2015

For the reversal of the effects of nondepolarizing neuromuscular blocking agents after surgery

No new safety issues were identified.

No regulatory actions required at this time.

Pazeo
(olopatadine hydrochloride ophthalmic solution) 0.7%, for topical ophthalmic administration
 

NDA 206276
 

January 30, 2015

For treating ocular itching associated with allergic conjunctivitis

No new safety issues were identified.

No regulatory actions required at this time.

Perjeta
(pertuzumab)
injection, for intravenous use
 

BLA 125409 (NME)
 

June 8, 2012

  • For use in combination with trastuzumab and docetaxel for treating patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
  • For use in combination with trastuzumab and docetaxel as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 centimeters or node positive) as part of a complete treatment regimen for early breast cancer. 

Two potential safety issues were identified from postmarketing adverse event reports:

  • Angioedema
  • Tumor lysis syndrome

FDA continues to evaluate adverse event reports of angioedema and tumor lysis syndrome to determine if regulatory action is required.

Phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10%
 

NDA 207926
 

January 15, 2015

For dilating the pupil

No new safety issues were identified.

No regulatory actions required at this time.

Pomalyst
(pomalidomide) capsules, for oral use
 

NDA 204026 (NME)
 

February 8, 2013

For use in combination with dexamethasone to treat patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy

Three potential safety issues were identified from postmarketing adverse event reports:

  • Ischemic colitis
  • Pancreatitis
  • Progressive multifocal leukoencephalopathy

FDA is evaluating adverse event reports of ischemic colitis, pancreatitis, and progressive multifocal leukoencephalopathy to determine if regulatory action is required.

Potassium chloride
oral solution
 

NDA 206814
 

December 22, 2014

For the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient

No new safety issues were identified.

No regulatory actions required at this time.

Savaysa
(edoxaban)
tablets, for oral use
 

NDA 206316 (NME)
 

January 8, 2015

  • For reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation

 

  • For treating deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial therapy with a parenteral anticoagulant therapy

No new safety issues were identified.

No regulatory actions required at this time.

Saxenda
(liraglutide)
injection, for subcutaneous use
 

NDA 206321
 

December 23, 2014

For use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia)

No new safety issues were identified.

No regulatory actions required at this time.

Simponi Aria
(golimumab)
injection, for intravenous use
 

BLA 125433 (NME)
 

July 18, 2013

For treating adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate

No new safety issues were identified.

No regulatory actions required at this time.

Toujeo
(insulin glargine injection) U-300, for subcutaneous use
 

NDA 206538
 

February 25, 2015

A long-acting human insulin analog for improving glycemic control in adults with diabetes mellitus

No new safety issues were identified.

No regulatory actions required at this time.

Trumenba
(Meningococcal Group B Vaccine)
 

BLA 125549
 

October 29, 2014

For active immunization to prevent invasive disease caused by Neisseria meningitides serogroup B in individuals 10 through 25 years of age

No new safety issues were identified.

No regulatory actions required at this time.

Viekira Pak
(ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets)
co-packaged for oral use
 

NDA 206619 (NME)
 

December 19, 2014

For treating adult patients with chronic hepatitis C virus genotype 1 infection

No new safety issues were identified.

No regulatory actions required at this time.

Xofigo
(radium Ra-223 dichloride)
injection, for intravenous use
 

NDA 203971 (NME)
 

May 15, 2013

For treating castration-resistant prostate cancer in patients with symptomatic bone metastases and no known visceral metastatic disease

No new safety issues were identified.

No regulatory actions required at this time.

Yervoy (ipilimumab)
injection, for intravenous use
 

BLA 125377 (NME)
 

March 25, 2011

  • For treating unresectable or metastatic melanoma
  • For use as an adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 millimeter who have undergone complete resection, including total lymphadenectomy

Six potential safety issues were identified from postmarketing adverse event reports:

  • Neutropenia and/or febrile neutropenia
  • Thrombocytopenia
  • Retinal detachment
  • Blindness
  • Rhabdomyolysis
  • Acute febrile neutrophilic dermatosis

FDA continues to evaluate adverse event reports to determine if regulatory action is required.

 

 

2007-2014 reports are in the FDA Archive

 

Page Last Updated: 07/24/2017
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