Drugs
Postmarketing Drug and Biologic Safety Evaluations
This website provides summary information about ongoing and completed postmarketing safety evaluations of adverse experience reports made to FDA for New Drug Applications (NDAs) and Biologic 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 postmarketing 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 website includes the table below which lists the names of products, application number, approval date, approved indication, summary of evaluation findings, and actions taken and ongoing surveillance activities. 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.
What information does FDA consider for these postmarketing 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 FDA's Adverse Event Reporting System (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?
FDA analyses for the safety evaluations include:
Data mining analysis of all adverse event reports in the AERS or VAERS databases
Review serious adverse event reports
Medication error analysis
Product utilization analysis
Risk management review
Analysis of post-approval safety data from clinical trials and other studies, when applicable
Beginning not later than 18 months after approval, scientists from CDER's Office of Surveillance and Epidemiology and Office of New Drugs jointly review the relevant data, summarize findings and, when necessary, develop a plan to further investigate potential new safety issues. 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 will compile the postmarket safety evaluations and post these summaries as quarterly reports going forward.
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 Adverse Event Reporting System (AERS), please refer to FDA's website on Postmarket Drug Safety Information for Patients and Providers or Safety and Availability (Biologics).
Postmarketing Drug Safety Evaluation Summaries
(previous Postmarketing Drug Safety Evaluations)
Postmarketing Drug Safety Evaluations completed from July 2011 through December 2011:
Product Name: Trade (Active Ingredient) NDA/BLA Number | Major Indication(s) | Summary of Evaluation Findings | Actions Taken and Ongoing Surveillance Activities |
|---|---|---|---|
| Acuvail NDA 022427 June 28, 2010 | For the treatment of pain and inflammation following cataract surgery. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| AK-FLUOR NDA 022186 August 8, 2008 | For diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Banzel NDA 021911 November 14, 2008 | For adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Bepreve
| For the treatment of itching associated with allergic conjunctivitis. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Codeine Sulfate
NDA 022402
July 16, 2009 | For the treatment of mild to moderate pain where the use of an opioid analgesic is appropriate. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Effient NDA 022307 July 10, 2009 | For the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows:
| Adverse event reports of hypersensitivity (allergic reactions) and intracranial hemorrhage were identified. | Hypersensitivity was added to the Warnings and Precautions, Patient Counseling Information, and Medication Guide sections of the labeling in September 2011. |
| Embeda NDA 022321 August 13, 2009 | For management of moderate to severe pain when a continuous, around- the-clock opioid analgesic is needed for an extended period of time. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| InterSol Solution
NDA BN080041 December 9, 2009 | An isotonic solution to replace a proportion of the plasma used in the storage of AMICUS™-derived leukoreduced apheresis platelets. | No new safety concerns were identified. | No regulatory actions required at this time. |
| Intuniv (Guanfacine hydrochloride)
NDA 022037 September 2, 2009 | For the treatment of Attention Deficit Hyperactivity Disorder as monotherapy and as adjunctive therapy to stimulant medications. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Invega Sustenna (Paliperidone palmitate)
NDA 022264 July 31, 2009 | For the acute and maintenance treatment of schizophrenia in adults. | Adverse event reports of medication errors involving use of the device (syringe) were identified. | FDA is continuing to evaluate this issue to determine if regulatory action is required. |
| Livalo (Pitavastatin)
NDA 022363 August 3, 2009
| For patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase high-density lipoprotein cholesterol. | Adverse event reports of interstitial lung disease, hepatitis, and jaundice were identified. | FDA is continuing to evaluate interstitial lung disease issues to determine if regulatory action is required. |
| Lysteda NDA 022430 November 13, 2009 | For the treatment of cyclic heavy menstrual bleeding.
| No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Metozolv ODT
September 4, 2009
| For the relief of symptomatic gastroesophageal reflux for short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Multaq
NDA 022425 July 1, 2009 | To reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation. | Adverse event reports of heart failure, liver failure, pneumonitis, pulmonary fibrosis, and increase in creatinine were identified. | Drug Safety Communication |
| Onglyza (Saxagliptin)
NDA 022350 July 31, 2009
| As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. | Adverse event reports of hypersensitivity (allergic reactions) and pancreatitis were identified. | Hypersensitivity reaction was added to the Contraindications, Warning and Precautions, Adverse Reactions, and Patient Counseling sections of the labeling in November 2011. |
| OraVerse
NDA 022159 May 9, 2008 | For reversal of soft-tissue anesthesia. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Oxaliplatin injection (Oxaliplatin injection)
NDA 022160 May 22, 2009 | For adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor and treatment of advanced colorectal cancer. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time.
|
Pennsaid
NDA 020947 November 4, 2009 | For the treatment of signs and symptoms of | Two medication errors reporting incorrect route of administration were reported. | A medication error review is being performed. No other regulatory actions required at this time. |
| Relistor
NDA 021964 April 24, 2008 | For the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. | Adverse event reports of drug withdrawal syndrome were identified. | FDA is continuing to evaluate this issue to determine if regulatory action is required. |
| Renvela
NDA 022318 August 12, 2009 | For the control of serum phosphorus in patients with chronic kidney disease on dialysis. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Saphris (Asenapine maleate) NDA 022117 August 13, 2009 | For the treatment of schizophrenia and acute treatment, as monotherapy or adjunctive therapy, of manic or mixed episodes associated with bipolar I disorder. | Adverse event reports of hypersensitivity (allergic reactions) were identified. | Drug Safety Communication Hypersensitivity was added to the Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling sections of the labeling in August 2011. |
| Silenor (Doxepin hydrochloride) NDA 022036 March 17, 2010 | For the treatment of insomnia characterized by difficulties with sleep maintenance. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Simponi (Golimumab) BLA 125289 April 4, 2009 | For the treatment of:
| No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Sumavel Dosepro (Sumatriptan succinate)
July 15, 2009 | For the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Twynsta (Amlodipine besylate and telmisartan)
| For the treatment of hypertension alone or with other antihypertensive agents and as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Valturna (Aliskiren hemifumarate and valsartan)
| For the treatment of hypertension in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Welchol (Colesevelam hydrocholoride)
| As an adjunct to diet and exercise to:
| Adverse event reports of dysphagia (difficulty in swallowing) Welchol oral suspension were identified. | Dysphagia associated with the oral suspension and tablet was added to the Adverse Reactions section of the labeling in January 2012. [Dysphagia associated with the tablet was added to the Warning and Precautions section of the labeling in July 2011.] |
| Zegerid OTC (Omeprazole/Sodium bicarbonate)
| For the treatment of heartburn (not more than 14 days). | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Zenpep (Pancrelipase)
| For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
Zirgan
NDA 022211
| For the treatment of acute herpetic keratitis (dendritic ulcers). | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
Previous Postmarketing Drug Safety Evaluation Summaries
Related Information
Questions and Answers on FDA’s Postmarketing Safety Summaries of Recently Approved Drugs and Biologics
6/15/2010FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals
FDA press release (6/15/2010)FDA Fact Sheet: FDAAA 2007 Section 915 - Enhancing FDA’s Safety Reporting on Recently Approved Therapies (PDF - 53KB)
6/15/2010Postmarket Drug Safety Information for Patients and Providers
