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 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, the report will be presented in two tables. The first table lists 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), and all biological products. The second table lists all other 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 January 1, 2016 to March 31, 2016
Product Name: Trade (active ingredient)
with Dosage form NDA/BLA Number Approval Date
Major IndicationsSummary of Findings from EvaluationActions taken and Ongoing Surveillance Activities

Adrenalin
(epinephrine injection) for intramuscular and subcutaneous use

NDA 204640

December 18, 2013

For emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.Adverse event reports of cardiomyopathy were identified.The Overdosage section of the label was updated to include information on cardiomyopathy.

Aleve PM

(naproxen sodium 220 mg/diphenhydramine hydrochloride 25 mg)

NDA 205352

January 16, 2014

For relief of occasional sleeplessness when associated with minor aches and pains.Potential for misuse of product for sleep without pain, resulting in inappropriate exposure to Nonsteroidal Anti-inflammatory Drugs (NSAIDs).FDA is evaluating this potential safety issue to determine if regulatory action is required.

Anoro Ellipta (umeclidinium bromide and vilanterol) inhalation powder, for oral inhalation

NDA 203975

New Molecular Entity (NME)

December 18, 2013

 

For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).No new safety issues were identified.No regulatory actions required at this time.

Aubagio (teriflunomide) tablet, for oral use

NDA 202992 (NME)

September 12, 2012

For treating patients with relapsing forms of multiple sclerosis.No new safety issues were identified.No regulatory actions required at this time.

Imbruvica (ibrutinib) capsule, for oral use

NDA 205552 (NME)

November 13, 2013

For treating patients with:
  • Mantle cell lymphoma
  • Chronic lympocytic leukemia
  • Waldenström’s macroglobulinemia

Three safety issues were identified from adverse event reports:

  • Central nervous system hemorrhage
  • Hepatic failure
  • Visual disturbances
The Warnings and Precautions section as well as the Adverse Reactions section of the label were updated to include information about intracranial hemorrhage, hepatic failure, and visual disturbance. No further regulatory actions required at this time.

Incruse Ellipta (umeclidinium bromide) inhalation powder, for oral inhalation

NDA 205382

April 30, 2014

For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

No new safety issues were identified.

No regulatory actions required at this time.

Morphine Sulfate injection, for intravenous or intramuscular use

NDA 204223

October 30, 2013

For the management of pain not responsive to non-narcotic analgesics.

Two safety issues were identified from adverse event reports:

  • Medication errors
  • Sleep apnea
  • FDA continues to evaluate: medication error reports of syringe malfunction to determine if regulatory action is required.
  • sleep apnea to determine if regulatory action is required.

Olysio (simeprevir) capsule, for oral use

NDA 205123 (NME)

November 22, 2013

For treating chronic hepatitis C virus (HCV) (genotype 1 or 4) infection as a component of a combination of antiviral treatment regimen.

Two safety issues were identified from adverse event reports:

  • Angioedema
  • Anaphylaxis
No regulatory actions required at this time.

Sovaldi (sofosbuvir) tablet, for oral use

NDA 204671 (NME)

December 6, 2013

For treating chronic hepatitis C virus (HCV) (genotype 1, 2, 3, or 4) infection as a component of a combination antiviral treatment regimen.

No new safety issues were identified.

No regulatory actions required at this time.

Spherusol (Coccidioides immitis spherule derived skin test antigen) solution for intradermal injection

BLA 125354

July 29, 2011

For detecting delayed-type hypersensitivity to Coccidioides immitis in individuals 18 to 64 years of age with a history of pulmonary coccidioidomycosis.No new safety issues were identified.No regulatory actions required at this time.

 

Page Last Updated: 07/05/2016
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