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)

New! April 1 – June 30, 2014

 

 Postmarket Drug and Biologic Safety Evaluations Completed from 
April 1 – June 30, 2014  

Product Name: Trade (active ingredient)
NDA/BLA Number
Approval Date

Major Indications

Summary of Findings from Evaluation

Actions taken and Ongoing Surveillance Activities

Advil Allergy and Congestion Relief (ibuprofen, 200 mg/phenylephrine HCl, 10 mg/chlorpheniramine maleate, 4 mg) tablets
NDA 022113
12/21/11

Temporary relief of symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
• runny nose
• itchy, watery eyes
• itching of the nose or throat
• sneezing
• nasal congestion
• sinus pressure
• headache
• minor aches and pains
• fever

No new safety concerns were identified.

No regulatory action required at this time.

Belviq (lorcaserin hydrochloride) tablets, 10 mg
NDA 022529 (NME)
6/27/12

Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) 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, dyslipidemia, type 2 diabetes).

No new safety concerns were identified. 

No regulatory action required at this time.

Absorica (isotretinoin) capsules, 10, 20, 30, and 40 mg
NDA 021951
5/25/12

Treatment of severe (many) recalcitrant nodular acne (inflammatory lesions with a diameter of 5 mm or greater) in patients 12 years of age and older.  It is reserved for patients unresponsive to conventional therapy, including systemic antibiotics. It is indicated only for those female patients who are not pregnant.

No new safety concerns were identified. 

No regulatory action required at this time.

Dymista (azelastine hydrochloride and fluticasone propionate) nasal spray, 137 μg/50 μg
NDA 202236
5/1/12

Relief of symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

No new safety concerns were identified. 

No regulatory action required at this time.

Indomethacin for injection
NDA 022536
3/17/10

To close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective.

No new safety concerns were identified.

No regulatory action required at this time.

Jentadueto (linagliptin and metformin hydrochloride) tablets
NDA 201281
1/30/12

An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin
and metformin is appropriate.

No new potential safety issues identified.

No regulatory action required at this time. Ongoing surveillance
of pancreatitis,
angioedema and
pancreatic malignancy
for the linagliptin
component continues.

Omontys (peginesatide) injection
NDA 202799 (NME)
3/27/12

Treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

No new safety concerns were identified.  

No regulatory action required at this time.

Picato (ingenol mebutate) gel, 0.015% and 0.05%
NDA 202833 (NME)
1/23/12

Treatment of AK lesions on the head (face and scalp) gel, 0.015% is to be applied topically to a 25 cm² treatment area once daily for 3 consecutive days. Treatment of AK lesions on the non-head (trunk and extremities) locations, gel, 0.05%, is to be applied topically to a 25 cm² treatment area once daily for 2 consecutive days.

Medication errors and use inconsistent with labeling, resulting in skin reactions and eye injuries, were identified as safety concerns. 

FDA is continuing to evaluate the effect of medication errors and use inconsistent with labeling,
resulting in skin reactions and eye injuries, to determine if regulatory action is required.

PrandiMet (repaglinide/metformin HCl fixed-dose combination) tablets
NDA 022386
6/23/08

An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin or who have inadequate glycemic control on a meglitinide alone or metformin alone.

No new safety concerns were identified. 

No regulatory action required at this time.

Prepopik (sodium picosulfate, magnesium oxide and citric acid) for oral solution, 10 mg sodium picosulfate/sachet
NDA 202535 (NME)
7/6/12

Cleansing of the colon as a preparation for colonoscopy in adults

No new safety concerns were identified. 

No regulatory action required at this time.

Suprenza (phentermine hydrochloride) oral disintegrating tablet
NDA 202088
6/13/11

Short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

No new safety concerns were identified. 

No regulatory action required at this time.

Trelstar (triptorelin pamoate for injectable suspension), 3.75 mg, 11.25 mg, and 22.5 mg
NDA 022437
3/10/10

Palliative treatment of advanced prostate cancer.

No new safety concerns were identified.

No regulatory action required at this time.

Vascepa (icosapent ethyl) capsules, 1 gram
NDA 202057
7/26/12

An adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

No new safety concerns were identified. 

No regulatory action required at this time.

Xiaflex (collagenase clostridium histolyticum)
BLA 125338 (NME)
2/2/10

The treatment of adult patients with Dupuytren’s contracture with a palpable
cord. The treatment of adult men with Peyronie’s disease with a palpable plaque and
curvature deformity of at least 30 degrees at the start of therapy.

Adverse event reports
of serious skin
laceration requiring
skin graft were
identified in patients with Dupuytren’s contracture.

FDA has requested labeling to be updated.

Zuplenz (ondansetron) oral soluble film, 4 mg and 8 mg

NDA 022524

7/2/10

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy.
 

• Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
• Prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to abdomen, or daily fractions to the abdomen

• Prevention of postoperative nausea and/or vomiting

No new safety concerns were identified. 

No regulatory action required at this time.

 

Page Last Updated: 01/02/2015
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