Drugs

Postmarket Drug and Biologic Safety Evaluations

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

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 October 1, 2016 to December 31, 2016
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

Argatroban
injection in 5% dextrose, for intravenous infusion only


NDA 201743
 

May 9, 2011

  • For use as prophylaxis or for treating thrombosis in adult patients with heparin-induced thrombocytopenia (HIT)
  • For use as an anticoagulant in patients with or at risk for HIT undergoing percutaneous coronary intervention

No new safety issues were identified.

No regulatory actions required at this time.

Benlysta
(belimumab)
injection, for intravenous use only
 

BLA 125370 (NME)
 

March 9, 2011

For treating adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy

No new safety issues were identified.

No regulatory actions required at this time.

Bloxiverz
(neostigmine methylsulfate)
injection, for intravenous use
 

NDA 204078
 

May 31, 2013

For reversing the effects of non-depolarizing neuromuscular blocking agents after surgery

No new safety issues were identified.

No regulatory actions required at this time.

Ceftazidime for injection USP and dextrose
injection USP,
for intravenous use
 

NDA 050823
 

June 13, 2011

For treating the following infections caused by susceptible isolates of the designated microorganisms:

  • lower respiratory tract infections
  • skin and skin-structure infections
  • bacterial septicemia
  • bone and joint infections
  • gynecologic infections
  • central nervous system infections

A safety issue of status epilepticus was identified from postmarketing adverse event reports.

FDA continues to evaluate the safety issue of status epilepticus to determine if regulatory action is required.

Coartem
(artemether and lumefantrine)
tablets, for oral use
 

NDA 022268 (NME)
 

April 7, 2009

For treating acute, uncomplicated malaria infections due to Plasmodium falciparum in patients of 5 kg bodyweight and above

A safety issue of hemolytic anemia, possibly associated with post-artemisinin delayed hemolysis, was identified from postmarketing adverse event reports.

FDA is evaluating adverse event reports of hemolytic anemia to determine if regulatory action is required.

Dotarem
(gadoterate meglumine) injection, for intravenous use
 

NDA 204781 (NME)
 

March 20, 2013

For use with magnetic resonance imaging in brain (intracranial), spine and associated tissues in patients 2 years of age and older to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity

No new safety issues were identified.

No regulatory actions are required at this time.

Harvoni
(ledipasvir and sofosbuvir)
tablets, for oral use
 

NDA 205834 (NME)
 

October 10, 2014

For use with or without ribavirin for treating patients with chronic hepatitis C virus genotype 1, 4, 5, or 6 infection

No new safety issues were identified.

No regulatory actions required at this time.

Hysingla ER
(hydrocodone bitartrate)
extended-release tablets, for oral use
 

NDA 206627
 

November 20, 2014

For managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

No new safety issues were identified.

No regulatory actions required at this time.

Invokamet
(canagliflozin and metformin hydrochloride)
tablets, for oral use
 

NDA 204353
 

August 8, 2014

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

A safety issue of nephrolithiasis was identified from postmarketing adverse event reports.

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

Jardiance
(empagliflozin)
tablets, for oral use
 

NDA 204629 (NME)
 

August 1, 2014

For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Two safety issues were identified from postmarketing adverse event reports:

  • Acute kidney injury
  • Pancreatitis

In December 2016, the “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling” sections of the prescribing information and the patient package insert were updated to include information regarding acute kidney injury.
FDA has completed its review of pancreatitis and has determined that no regulatory action is needed at this time.

Kcentra
(prothrombin complex concentrate (human))
 

BLA 125421
 

April 29, 2013

For the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding or need an urgent surgery/invasive procedure

Reports of product label confusion and wrong dose administration were identified.

FDA is evaluating this issue to determine if regulatory action is required.

Lymphoseek
(technetium Tc 99m tilmanocept)
injection, for subcutaneous, intradermal, subareolar, or peritumoral use
 

NDA 202207 (NME)
 

March 13, 2013

A radioactive diagnostic agent for use with or without scintigraphic imaging:

  • to locate lymph nodes draining a primary tumor site in patients with solid tumors as part of intraoperative management;
  • to guide sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma

No new safety issues were identified.

No regulatory actions required at this time.

Movantik
(naloxegol)
tablets, for oral use
 

NDA 204760 (NME)
 

September 16, 2014

For treating opioid-induced constipation in adult patients with chronic non-cancer pain

No new safety issues were identified.

No regulatory actions required at this time.

Namzaric
(memantine and donepezil hydrochlorides) extended-release capsules, for oral use
 

NDA 206439
 

December 23, 2014

For the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily

No new safety issues were identified.

No regulatory actions required at this time.

Paricalcitol
injection, for intravenous use
 

NDA 201657
 

October 21, 2014

An active vitamin D2 analog for preventing and treating secondary hyperparathyroidism associated with chronic kidney disease Stage 5

No new safety issues were identified.

No regulatory actions required at this time.

Rytary
(carbidopa and levodopa)
extended-release capsules, for oral use
 

NDA 203312
 

January 7, 2015

For treating Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication

No new safety issues were identified.

No regulatory actions required at this time.

Soolantra
(ivermectin)
cream, 1%, for topical use
 

NDA 206255
 

December 19, 2014

For treating inflammatory lesions of rosacea

Two safety issues were identified from postmarketing adverse event reports:

  • Contact dermatitis
  • Allergic contact dermatitis

FDA is evaluating adverse event reports of contact dermatitis and allergic contact dermatitis to determine if regulatory action is required.

Subsys
(fentanyl)
sublingual spray
 

NDA 202788
 

January 4, 2012

For managing breakthrough pain in adult opioid tolerant cancer patients

A safety issue of a burning sensation at the application site was identified from postmarketing adverse event reports.

FDA is evaluating adverse event reports of a burning sensation at the application site to determine if regulatory action is required.

Testosterone
gel, for topical use
 

NDA 203098
 

January 31, 2013

For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

No new safety issues were identified.

No regulatory actions required at this time.

Tobi Podhaler
(tobramycin)
inhalation powder, for oral inhalation use
 

NDA 201688
 

March 22, 2013

For managing cystic fibrosis patients with Pseudomonas aeruginosa

No new safety issues were identified.

No regulatory actions required at this time.

Trulicity
(dulaglutide)
injection, for subcutaneous use
 

BLA 125469 (NME)
 

September 18, 2014

For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

A safety issue of device malfunction was identified from postmarketing adverse event reports.

FDA continues to evaluate reports of device malfunction to determine if regulatory action is required.

Xigduo XR (dapagliflozin and metformin hydrochloride
extended-release) tablets, for oral use
 

NDA 205649
 

October 29, 2014

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

No new safety issues were identified.

No regulatory actions required at this time.

 

 

Page Last Updated: 03/31/2017
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