Drugs

Postmarket Drug and Biologic Safety Evaluations

Important Update [July 21, 2017]: Information FDA Considers During Postmarket Safety Evaluations (PDF -  79KB).
Important Update [October 6, 2017] The October 6, 2017 posting will serve as the final “Postmarket Drug and Biologic Safety Evaluations” posting (posted in accordance with the previous requirement in section 505(r) as added by section 915 of FDAAA): 915 Web Statement (Last Posting) (PDF  - 12KB).

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 April 1, 2017 to June 30, 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

Aptensio XR
(methylphenidate hydrochloride)
extended-release capsules, for oral use
 

NDA 205831
 

April 17, 2015

For treating attention deficit hyperactivity disorder

The potential safety issue of dystonia was identified from postmarketing adverse event reports.

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

Aptiom (eslicarbazepine acetate)
tablets, for oral use
 

NDA 022416 (NME)
 

November 8, 2013

For treating partial-onset seizures as monotherapy or adjunctive therapy

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

  • Hematologic events
  • Syndrome of inappropriate ntidiuretic hormone secretion (SIADH)
  • Atrioventricular block

On September 13, 2017, an efficacy supplement for Aptiom was approved and included the addition of SIADH to the existing “Warnings and Precautions” subsection describing the risk for hyponatremia, and the addition of a new “Warnings and Precautions” subsection describing the risk for hematologic adverse reactions.  It was determined that no regulatory actions related to atrioventricular block are required at this time.

Bexsero
(Meningococcal Group B Vaccine)
 

BLA 125546
 

January, 23, 2015

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

No new safety issues were identified.

No regulatory actions required at this time.

Corlanor (ivabradine) tablets, for oral use
 

NDA 206143 (NME)
 

April 15, 2015

For reducing the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction less than or equal to 35 percent, who are in sinus rhythm with resting heart rate greater than or equal to 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use

No new safety issues were identified.

No regulatory actions required at this time.

Epiduo Forte
(adapalene and benzoyl peroxide) gel, 0.3%/2.5% is for topical use
 

NDA 207917
 

July 15, 2015

For the topical treatment of acne vulgaris

No new safety issues were identified.

No regulatory actions required at this time.

Gardasil 9
(Human Papillomavirus 9-valent Vaccine, Recombinant)
 

BLA 125508
 

December 10, 2014

Prevention of  cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18, 31, 33, 45, 52, and 58 and genital warts (condyloma acuminata) caused by HPV types 6 and 11

No new safety issues were identified.

No regulatory action required at this time.

Injectafer
(ferric carboxymaltose)
injection, for intravenous use
 

NDA 203565
 

July 25, 2013

An iron replacement product for treating iron deficiency anemia in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron;
  • who have non-dialysis dependent chronic kidney disease

No new safety issues were identified.

No regulatory actions required at this time.

Jevtana (cabazitaxel)  
injection, for intravenous use
 

NDA 201023 (NME)
 

June 17, 2010

For treating hormone-refractory metastatic prostate cancer

The potential safety issue of tumor lysis syndrome was identified from postmarketing adverse event reports.

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

Noxafil
(posaconazole)
delayed-release tablets, for oral use
 

NDA 205053
 

November 25, 2013

For use as a prophylaxis of invasive Aspergillus and Candida infections in patients (13 years of age and older) who are at high risk of developing these infections

No new safety issues were identified.

No regulatory actions required at this time.

Opdivo (nivolumab), solution for injection
 

BLA 125527, 125554 (NME)
 

December 22, 2014

For treating:

  • BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent
  • BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single agent
  • Unresectable or metastatic melanoma, in combination with ipilimumab
  • Metastatic non-small cell lung cancer and progression on or after platinum based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo
  • Advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy
  • Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin
  • Recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
  • Locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherapy; have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

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

  • Retinal detachment
  • Severe vision loss
  • Tumor lysis syndrome

 

FDA continues to evaluate adverse event reports of retinal detachment, severe vision loss, and tumor lysis syndrome to determine if regulatory action is required.

Otrexup
(methotrexate)
injection, for subcutaneous use only
 

NDA 204824
 

October 11, 2013

  • For managing severe, active rheumatoid arthritis in selected adults or children with active polyarticular juvenile idiopathic arthritis, who have had insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents
  • For controlling symptoms of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation

 

Potential device-related safety issues were identified from postmarketing adverse event reports.

No regulatory action required at this time.

ProAir RespiClick (albuterol sulfate) inhalation powder, for oral inhalation use
 

NDA 205636
 

March 31, 2015

  • For treating or preventing bronchospasm in patients 4 years of age and older with reversible obstructive airway disease

 

  • For preventing exercise-induced bronchospasm in patients 4 years of age and older

No new safety issues were identified.

No regulatory actions required at this time.

Tuzistra XR
(codeine polistirex and chlorpheniramine polistirex)
extended-release oral suspension, CIII
 

NDA 207768
 

April 30, 2015

For relief of cough symptoms associated with upper respiratory allergies or a common cold

No new safety issues were identified.

No regulatory actions required at this time.

Velphoro
(sucroferric oxyhydroxide)
chewable tablets, for oral use
 

NDA 205109
 

November 27, 2013

For the control of serum phosphorus levels in patients with chronic kidney disease on dialysis

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

  • Tooth discoloration
  • Rash

On August 3, 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 tooth discoloration and rash.

Zarxio
(filgrastim-sndz)
injection, for subcutaneous or intravenous use
 

BLA 125553
 

March 6, 2015

  • For decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever
  • For reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
  • For reducing the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation
  • For mobilizing autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
  • For reducing the incidence and duration of sequelae of severe neutropenia (e.g. fever, infections, orophyaryngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia

No new safety issues were identified.

No regulatory actions required at this time.

Zortress
(everolimus)
tablets, for oral use
 

NDA 021560
 

April 20, 2010

For the prophylaxis of organ rejection in adult patients

No new safety issues were identified.

No regulatory actions required at this time.


 

 

Drug Safety Evaluations Completed July 1, 2017 to September 30, 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

Finacea
(azelaic acid) foam, 15% for topical use
 

NDA 207071
 

July 29, 2015

For the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea

No new safety issues were identified.

No regulatory actions required at this time.

Humalog (insulin lispro) injection, for subcutaneous or intravenous use
 

NDA 205747
 

May 26, 2015

A concentrated (200 units/ml) rapid acting human insulin analog for improving glycemic control in adults and children with diabetes mellitus

No new safety issues were identified.

No regulatory actions required at this time.

Ibrance (palbociclib) capsules, for oral use
 

NDA 207103 (NME)
 

February 3, 2015

For treating hormone receptor (HR)-positive, human epidermal growth receptor 2 (HER-2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women; or fulvestrant in women with disease progression following endocrine therapy

No new safety issues were identified.

No regulatory actions required at this time.

Prezcobix
(darunavir and cobicistat)
tablets, for oral use
 

NDA 205395
 

January 29, 2015

For use in combination with other antiretroviral agents for treating HIV-1 infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions

No new safety issues were identified.

No regulatory actions required at this time.

Stiolto Respimat
(tiotropium bromide and olodaterol)
inhalation spray, for oral inhalation use
 

NDA 206756
 

May 21, 2015

For long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease

No new safety issues were identified.

No regulatory actions required at this time.

Triumeq (abacavir, dolutegravir, and lamivudine)
tablets, for oral use
 

NDA 205551
 

August 22, 2014

For treating human immunodeficiency virus (HIV-1) infection

The potential safety issue of anxiety was identified from postmarketing adverse event reports.

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

Viberzi (eluxadoline) 
tablets, for oral use
 

NDA 206940 (NME)
 

May 27, 2015

For treating irritable bowel syndrome with diarrhea in adults

The potential safety issue of hypersensitivity reactions, including anaphylaxis, was identified from postmarketing adverse event reports.

FDA continues to evaluate adverse event reports of hypersensitivity reactions, including anaphylaxis, to determine if regulatory action is required.

 

 

2007-2014 reports are in the FDA Archive

 

Page Last Updated: 10/06/2017
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