Drug Safety Information for MOVANTIK (Naloxegol oxalate)

FDA Safety-related Labeling Changes for MOVANTIK (NALOXEGOL OXALATE) Rx Drug: Safety Information Link

Required post-approval safety study:

A post-marketing, observational epidemiologic study comparing MOVANTIK (naloxegol) to other treatments of opioid induced constipation in patients with chronic non-cancer pain. The study�s primary outcome is a composite of major adverse cardiovascular events (MACE): cardiovascular (CV) death, nonfatal myocardial infarction, and nonfatal stroke. Secondary outcomes include, but are not limited to, CV death, nonfatal myocardial infarction, and nonfatal stroke separately. Specify concise case definitions and validation algorithms for the primary and secondary outcomes. Justify the choice of appropriate comparator population(s) and estimated background rate(s) relative to MOVANTIK (naloxegol)-exposed patients clearly define the primary comparator population for the primary objective. Design the study around a testable hypothesis to assess, with sufficient sample size and power, MACE risk among MOVANTIK (naloxegol) users relative to comparator(s) considering important potential confounders including lifestyle risk factors and over the counter (OTC) medications with potential for cardiovascular effects, with a pre-specified statistical analysis method. For the MOVANTIK (naloxegol)-exposed and comparator(s), clearly define the new user clean period, including any exclusion and inclusion criteria. Ensure an adequate number of patients with at least 12 months of MOVANTIK (naloxegol) exposure at the end of the study. Due Date: 2023-12-31

Original FDA Drug Approval Date for MOVANTIK: 2014-09-16

Adverse Drug Reactions for MOVANTIK* (Naloxegol oxalate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with MOVANTIK
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Abdominal pain	7
2	Drug withdrawal syndrome	7
3	Pain	6
4	Nausea	6
5	Anxiety	5
6	Drug intolerance	5
7	Diarrhoea	5
8	Constipation	5
9	Drug ineffective	3
10	Vomiting	3
11	Frequent bowel movements	3
12	Blood pressure increased	2
13	Hyperhidrosis	2
14	Abdominal pain upper	2
15	Back pain	2
16	Convulsion	2
17	Muscle spasms	2
18	Abdominal distension	2
19	Chills	2
20	Adverse event	2

* This side effect also appears in "Top 10 Side Effects of MOVANTIK " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking MOVANTIK
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Constipation	82
2	Steroid therapy	2
3	Wheelchair user	2
4	Frequent bowel movements	2

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for MOVANTIK

Total Reports Filed with FDA: 111

Number of FDA Adverse Event Reports by Patient Age for MOVANTIK

Total Reports Filed with FDA: 111*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Naloxegol oxalate (Movantik)

Charts are based on 111 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.