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)

 

 Postmarket Drug and Biologic Safety Evaluations Completed from 
January - March 2015  
Product Name: Trade (active ingredient)
NDA/BLA Number
Approval Date
Major IndicationsSummary of Findings from EvaluationActions taken and Ongoing Surveillance Activities

Abilify Maintena (aripiprazole) Injection
NDA 202971
February 28, 2013

Schizophrenia

No new safety issues were identified.

No regulatory actions required at this time.

Adrenalin (epinephrine) Injection
NDA 204200
December 7, 2012

  • Emergency treatment of allergic reactions (Type 1) including anaphylaxis.

  • Induction and maintenance of mydriasis during intraocular surgery. 

No new safety issues were identified.

No regulatory actions required at this time.

Eliquis (apixaban)
Tablet
NDA 202155 (NME)
December 28, 2012

 

  • Reduction of risk of stroke and systemic embolism in Non-valvular atrial fibrillation

  • Prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery

  • Treatment of DVT

  • Treatment of pulmonary embolism (PE)

  • Reduction in the risk of recurrence of DVT and PE

No new safety issues were identified.

No regulatory actions required at this time.

Makena
(hydroxyprogesterone caproate) Injection
NDA 021945
February 3, 2011

To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

No new safety issues were identified.

No regulatory actions required at this time.

Nesina
(alogliptin) Tablet
NDA 022271 (NME)
January 25, 2013

An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

We identified adverse event reports of diarrhea, constipation, nausea, and ileus.

We are continuing our evaluation of these potential safety issues to determine if regulatory action is required.

Nithiodote
(sodium nitrate, sodium thiosulfate pentahydrate)
Injection
NDA 201444
January 14, 2011

Sequential use for treating acute cyanide poisoning that is judged to be life-threatening.

No new safety issues were identified.

No regulatory actions required at this time.

Osphena
(ospemifene) Tablets
NDA 203505 (NME)
February 26, 2013

Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

No new safety issues were identified.

No regulatory actions required at this time.

Phenylephrine Hydrochloride (phenylephrine hydrochloride)
10mg/ml solution for infusion
NDA 203826
December 20, 2012

For increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation.

No new safety issues were identified.

No regulatory actions required at this time.

Provenge
(sipuleucel-T)
Intravenous infusion
BLA 125197
April 29, 2010

Treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

No new safety issues were identified.

No regulatory actions required at this time.

Skyla
(levonorgestrel-releasing intrauterine system)
NDA 203159
January 9, 2013

For the prevention of pregnancy for up to 3 years.

No new safety issues were identified.

No regulatory actions required at this time.

Suclear
(sodium sulfate, potassium sulfate and magnesium sulfate oral solution; and PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride)
Oral solution
NDA 203595
January 18, 2013

Used for cleansing the colon as a preparation for colonoscopy in adults.

No new safety issues were identified.

No regulatory actions required at this time.

Tecfidera
(dimethyl fumarate)
Delayed-action capsule
NDA 204063 (NME)
March 27, 2013

Indicated for treating adult patients with relapsing forms of multiple sclerosis.

We identified 4 safety issues:

  • acute pancreatitis (adverse event and literature reports)

  • acute renal failure (adverse event reports)

  • gastrointestinal hemorrhage, ulceration, perforation, and obstruction (adverse event reports)

  • underdosing and wrong frequency (medication error and literature reports)

     

We continue to evaluate all of these safety issues to determine if regulatory actions are required.

Topicort (desoximetasone) Topical spray, 0.25%
NDA 204141
April 11, 2013

A corticosteroid indicated for treating plaque psoriasis in patients 18 years of age or older.

No new safety issues were identified.

No regulatory actions required at this time.

Uceris
(budesonide)
Extended-release tablet
NDA 203634
1/14/2013

Indicated for inducing remission in patients with active, mild to moderate ulcerative colitis.

No new safety issues were identified.

No regulatory actions required at this time.

Vimpat
(lacosamide)
Oral solution
NDA 022255
April 20, 2010

Used as monotherapy or adjunctive therapy in patients with partial onset seizures.

No new safety issues were identified.

No regulatory actions required at this time.

Votrient
(pazopanib hydrochloride)
Tablets
NDA 022465 (NME)
October 19, 2009

  • For treating patients with advanced renal cell carcinoma (RCC).

  • For treating patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.

Limitation of Use: The efficacy of VOTRIENT for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated.

We identified 5 potential safety issues from adverse event reports of:

  • Retinal detachment

  • Interstitial lung disease

  • Acute renal failure

  • Pericardial effusion

  • Hyperthyroidism

     

The sponsor revised the labeling to include retinal detachment in the postmarketing experience section.
We are continuing our evaluation of the other 4 potential safety issues to determine if regulatory action is required.

Xarelto (rivaroxaban)
Tablet
NDA 202439
November 4, 2011

  • To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

  • For treating deep vein thrombosis (DVT), pulmonary embolism (PE), and for reducing the risk recurring DVT and PE.

  • For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

No new safety issues were identified.

No regulatory actions required at this time.

 

 

 

 

 

 

 

Page Last Updated: 06/30/2015
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