Drug Safety Information for OPANA ER (Oxymorphone hydrochloride)

Safety-related Labeling Changes for OPANA (OXYMORPHONE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for OPANA ER (OXYMORPHONE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for OPANA (OXYMORPHONE HYDROCHLORIDE) Rx Drug: FDA Link

Required post-approval safety study:

A prospective, observational study designed to quantify the serious risks of misuse, abuse, and addiction associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed ER/LA opioid analgesics. This study must address at a minimum the following specific objectives: a. Estimate the incidence of misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain. Examine the effect of product/formulation, dose and duration of opioid use, prescriber specialty, indication, and other clinical factors (e.g., concomitant psychotropic medications, personal or family history of substance abuse, history of psychiatric illness) on the risk of misuse, abuse, and addiction. b. Evaluate and quantify other risk factors for misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain, including but not limited to the following: demographic factors, psychosocial/behavioral factors, medical factors, and genetic factors. Identify confounders and effect modifiers of individual risk factor/outcome relationships. Due Date: 2020-03-31

Required post-approval safety study:

Deferred pediatric study of safety and pharmacokinetics (single- and multipledose) under PREA for the relief of moderate to severe pain in patients requiring a continuous, around-the-clock opioid treatment for an extended period of time in pediatric patients ages 7 to 17 years. Due Date: 2020-04-30

Original FDA Drug Approval Date for OPANA ER: 2006-06-22

Adverse Drug Reactions for OPANA ER* (Oxymorphone hydrochloride)

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 OPANA ER
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug abuse	681
2	Drug ineffective	626
3	Toxicity to various agents	333
4	Nausea*	268
5	Drug effect decreased	250
6	Wrong technique in drug usage process	234
7	Vomiting	203
8	Intentional drug misuse	178
9	Incorrect route of drug administration	169
10	Withdrawal syndrome	158
11	Malaise	158
12	Overdose	151
13	Death	149
14	Pain*	144
15	Headache	137
16	Feeling abnormal	129
17	Drug diversion	129
18	Completed suicide	118
19	Cardiac arrest	117
20	Diarrhoea	115

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

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

	Reason	# of FDA Reports
1	Pain*	3442
2	Product used for unknown indication	3344
3	Drug abuse	1050
4	Back pain*	748
5	Breakthrough pain	444
6	Arthralgia	138
7	Pain in extremity	112
8	Fibromyalgia*	107
9	Neck pain	91
10	Drug diversion	78

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

Types of Adverse Events for OPANA ER

Total Reports Filed with FDA: 14962

Number of FDA Adverse Event Reports by Patient Age for OPANA ER

Total Reports Filed with FDA: 14962*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Oxymorphone hydrochloride (Opanaer, Oxymorphone, Opana, Numorphan, Opana er)

Charts are based on 14962 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.