Document Detail


Safety of EMBEda (morphine sulfate and naltrexone hydrochloride) extended-release capsules: review of postmarketing adverse events during the first year.
MedLine Citation:
PMID:  22616317     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: EMBEDA@ (morphine sulfate and naltrexone hydrochloride) extended-release capsules, indicated for management of chronic, moderate-to-severe pain, contain pellets of morphine sulfate with a core of sequestered naltrexone, an opioid antagonist.
OBJECTIVE: To review postmarketing adverse event (AE) reports received during first year following approval.
METHODS: All postmarketing AEs reported to the manufacturer were reviewed.
RESULTS: During the reporting period, approximately 97,000 prescriptions for EMBEDA were dispensed. One hundred eighty-two case reports containing 429 events were reviewed; 33 (18 percent) were reported as serious and 149 (82 percent), as non-serious. Of 429 AEs reported, the most common were drug ineffective (7 percent), headache (6 percent), drug withdrawal syndrome (6 percent), and nausea (4 percent). Seven cases involved oral overdose; of these, two suicide attempts resulted in fatalities. Product tampering was confirmed in six cases; suspected in five. No cases of confirmed tampering resulted in fatality; none resulted in symptoms typically associated with opioid overdose. Three were associated with opioid withdrawal symptoms, suggesting that naltrexone released during tampering potentially blocked the opioid effects. Twenty-five cases involving reported withdrawal or symptoms of withdrawal were reviewed; most were associated with dose interruption, capsule manipulation, history of drug abuse, or intolerance to a new opioid regimen.
CONCLUSIONS: Results suggest that the safety profile of EMBEDA is consistent with that of an extended-release morphine formulation. Reports of exposure to tampered product yielded either withdrawal reactions or events not typical of opioid abuse. The clinical effects of EMBEDA in the context of misuse and abuse require further clinical and epidemiological exploration.
Authors:
Vincent C Badalamenti; Jill W Buckley; Eric T Smith
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of opioid management     Volume:  8     ISSN:  1551-7489     ISO Abbreviation:  J Opioid Manag     Publication Date:    2012 Mar-Apr
Date Detail:
Created Date:  2012-05-23     Completed Date:  2012-06-14     Revised Date:  2012-09-21    
Medline Journal Info:
Nlm Unique ID:  101234523     Medline TA:  J Opioid Manag     Country:  United States    
Other Details:
Languages:  eng     Pagination:  115-25     Citation Subset:  IM    
Affiliation:
Pharmacovigilance, Worldwide Safety and Regulatory Operations, Pfizer Inc., Cary, North Carolina, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Adverse Drug Reaction Reporting Systems*
Aged
Aged, 80 and over
Analgesics, Opioid / adverse effects*,  therapeutic use
Capsules
Delayed-Action Preparations
Drug Combinations
Female
Humans
Male
Middle Aged
Morphine / adverse effects*,  therapeutic use
Naltrexone / adverse effects*,  therapeutic use
Narcotic Antagonists / adverse effects*,  therapeutic use
Overdose
Pain / drug therapy
Substance Withdrawal Syndrome / etiology
Young Adult
Chemical
Reg. No./Substance:
0/Analgesics, Opioid; 0/Capsules; 0/Delayed-Action Preparations; 0/Drug Combinations; 0/Narcotic Antagonists; 0/morphine, naltrexone combination; 16590-41-3/Naltrexone; 57-27-2/Morphine
Comments/Corrections
Comment In:
J Opioid Manag. 2012 Jul-Aug;8(4):207   [PMID:  22941847 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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